reaching every heart’s
potential

Patient well-being is at the core of everything we do. 

And it’s where our unwavering focus will always
be. Because like you, we’re relentlessly
dedicated to restoring healthy hearts that are
filled with possibilities. And ready to make a 
lifetime of cherished memories.

 

Our SolutionsAbbott Structural Heart

EXPLORE THE INTERACTIVE HEART MODEL BELOW
TO LEARN ABOUT OUR STRUCTURAL HEART PORTFOLIO

Learn how to navigate the Heart Model
Use arrows to navigate 
between therapies
Click to see more details about each therapy solution
Click to zoom in
Click on button to learn more about the therapy
ok, got it!
MitraClip
MITRACLIP TMVr IS NOW APPROVED FOR MORE PATIENTS

MitraClipTM is now approved for select heart failure patients with secondary mitral regurgitation, backed by groundbreaking data from the COAPT study.
 

Learn more

Amplatzer PFO Occluder
THE LEADING PFO
CLOSURE DEVICE5

AmplatzerTM PFO Occluder created the category of PFO occlusion, sustained leadership over decades of use, and was the first device supported by positive PFO trial results.
 

Learn more

Trifecta GT
Hemodynamics Matter
Because Patients’ Lives Matter

The TrifectaTM valve with Glide Technology (GT) and Linx anticalcification (AC) technology offers patients exceptional hemodynamics6-11,* and excellent performance.12
 

Learn more

Every Heart has 
a Story

The testimonials relate to accounts of individuals’ responses to treatments. The patients’ accounts are genuine, typical and documented. However, it does not provide any indication, guide, warranty, or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

  • Betty: “Feeling Lucky” to be Treated with MitraClip

    “A couple years ago my doctor said to just “live with it,” [my symptoms]—but it wasn’t living, it was existing. I would have ended up in a nursing home.” After the MitraClipTM procedure “I’m doing anything and everything I want; I’m back to living again.”

  • Alan: Finally “Getting the Care” He Needed with AMPLATZER PFO Occluder

    “It’s scary,” said Alan, who had had a stroke due to a patent foramen ovale, and who didn’t know if and when he might have a recurrent stroke. After AmplatzerTM PFO closure “He’s like a new man,” his wife, Emma, remarked about Alan, who’s back to walking 12 miles a day as a mail carrier. “And I owe everyone a massive thank you,” Alan said.

  • Jozef: “Finding Just the Right Device” Helped Turn His Life Around

    Over time Jozef’s ventricular septal defect (VSD) precipitated endocarditis which in turn led to heart failure and kidney failure. After receiving the AmplatzerTM VSD Occluder Jozef, amazed at his energy and ability to walk long distances again, said “I feel joy deep inside me—inside my heart.”

  • Betty: “Feeling Lucky” to be Treated with MitraClip

    “A couple years ago my doctor said to just “live with it,” [my symptoms]—but it wasn’t living, it was existing. I would have ended up in a nursing home.” After the MitraClipTM procedure “I’m doing anything and everything I want; I’m back to living again.”

  • Alan: Finally “Getting the Care” He Needed with AMPLATZER PFO Occluder

    “It’s scary,” said Alan, who had had a stroke due to a patent foramen ovale, and who didn’t know if and when he might have a recurrent stroke. After AmplatzerTM PFO closure “He’s like a new man,” his wife, Emma, remarked about Alan, who’s back to walking 12 miles a day as a mail carrier. “And I owe everyone a massive thank you,” Alan said.

  • Jozef: “Finding Just the Right Device” Helped Turn His Life Around

    Over time Jozef’s ventricular septal defect (VSD) precipitated endocarditis which in turn led to heart failure and kidney failure. After receiving the AmplatzerTM VSD Occluder Jozef, amazed at his energy and ability to walk long distances again, said “I feel joy deep inside me—inside my heart.”

AP2947149-WBU Rev. C

References

*For References 3-8, information is taken from pericardial valve IFUs, not from a head-to-head clinical trial. Information provided for educational purposes only.

  1. MitraClip NTR/XTR System Instructions for Use.
  2. Data on file at Abbott.
  3. Avalus bioprosthesis [package insert]. Minneapolis, MN: Medtronic; table 8.
  4. Intuity Elite valve system [package insert]. Irvine, CA: Edwards Lifesciences; table 13.6.
  5. Carpentier-Edwards PERIMOUNT Manga Ease aortic heart valve [package insert]. Irvine, CA: Edwards Lifesciences; table 7.
  6. Perceval sutureless heart valve [package insert]. London, UK: LivaNova; table 12.
  7. Edwards pericardial aortic bioprosthesis [package insert for Resilia valve]. Irvine, CA: Edwards Lifesciences; table 9.
  8. TrifectaTM valve [package insert]. Chicago, IL: Abbott; table 9.
  9. Bavaria JE, et al. The St Jude Medical TrifectaTM aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014;147:590-597.
     
Important safety information
  • MitraClip

    MITRACLIP CLIP DELIVERY SYSTEMS
    INDICATION FOR USE

    • The MitraClip™ NTR/XTR System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
    • The MitraClip™ NTR/XTR System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

    CONTRAINDICATIONS

    The MitraClip™ NTR/XTR System is contraindicated in patients with the following conditions:

    • Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
    • Active endocarditis of the mitral valve
    • Rheumatic mitral valve disease
    • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

    WARNINGS

    • DO NOT use MitraClip™ outside of the labeled indication.
    • The MitraClip™ Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
    • Read all instructions carefully.  Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip™ System to avoid user injury.
    • Use of the MitraClip™ should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.
    • The Clip Delivery System is provided sterile and designed for single use only.  Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device or other serious injury or death.
    • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.

    PRECAUTIONS

    • Note the product “Use by” date specified on the package.
    • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
    • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation
      • Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
      • 30-day STS predicted operative mortality risk score of
        • ≥8% for patients deemed likely to undergo mitral valve replacement or
        • ≥6% for patients deemed likely to undergo mitral valve repair
      • Porcelain aorta or extensively calcified ascending aorta.
      • Frailty (assessed by in-person cardiac surgeon consultation).
      • Hostile chest
      • Severe liver disease / cirrhosis (MELD Score > 12)
      • Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
      • Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery(IMA) at high risk of injury, etc.
      • Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF < 20% or an LVESD > 60 mm.  MitraClip® should be used only when criteria for clip suitability for DMR have been met.
      • The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
    • Secondary Mitral Regurgitation
      • Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
      • The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

    POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

    The following ANTICIPATED EVENTS have been identified as possible complications of the
    MitraClipTM procedure.

    Death; Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding;
    Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast
    media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClipTM to the intended site; Failure to retrieve MitraClipTM System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClipTM System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence

  • Epic

    EPICTM/ EPICTM SUPRA STENTED PORCINE TISSUE VALVES
    INDICATION FOR USE


    The EpicTM valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. The EpicTM Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    None known.

    WARNINGS

    • Valve size selection is based on the size of the recipient annulus, and for supra-annular aortic placement, the anatomy of the sinotubular space. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. The use of an inappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude MedicalTM Bioprosthetic Heart Valve Sizer Set Model B1000 with the Epic and Epic Supra valves.
    • Accelerated deterioration due to calcific degeneration of the Epic and Epic Supra valve may occur in:
      • children, adolescents, or young adults;
      • patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure); or
      • individuals requiring hemodialysis.
    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Do not use if:
      •  the valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration;
      • the expiration date has elapsed;
      • the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging; or
      • the storage solution does not completely cover the valve.

    PRECAUTIONS

    • The safety and effectiveness of the EpicTM and EpicTM Supra valves has not been established for the following specific populations:
      • patients who are pregnant
      • nursing mothers
      • patients with chronic renal failure
      • patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • patients with chronic endocarditis
      • patients requiring pulmonic or tricuspid valve replacement
      • children, adolescents, or young adults
    • Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, deformed, or damaged sizer set components.
    • Do not pass the flanged portion of the valve replica sizing tool through the annulus.
    • Do not place the non-sterile exterior of the valve container in the sterile field.
    • Do not expose the valve to solutions other than the formaldehyde valve storage solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the valve.
    • Do not add antibiotics to either the formaldehyde valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in sterile isotonic saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5 °C to 25 °C range.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Do not lacerate the valve tissue. If a valve is damaged, the valve must be explanted and replaced.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    •  Do not use cutting edge needles, unprotected forceps, or sharp instruments as they may cause structural damage to valve.
    • Never handle the leaflet tissue.
    • Position the mitral valve in a manner to avoid commissure obstruction of the left ventricular outflow tract, and minimize any potential of commissure contact with the ventricular wall.
    • Position the aortic valve so that the stent posts do not obstruct the coronary ostia.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.

    ADVERSE EVENTS

    The clinical investigation of the Epic valve supports the safety and effectiveness of the Epic valve and the Epic Supra valve. Between January 2003 and March 2006, seven-hundred and sixty-two (762) subjects were implanted with 791 Epic Valve(s) at 19 investigational sites in the United States (U.S.), and three sites in Canada. Five-hundred and fifty-seven (557) subjects received isolated aortic replacement, 176 received isolated mitral replacement, and 29 received replacement of both the aortic and mitral valves. The cumulative follow-up for all subjects was 773.51 patient-years with a mean follow-up of 1.02 patient-years (s.d. = 0.71 patient-years, range 0 – 3.10 patient-years).

    Potential Adverse Events

    Adverse events potentially associated with the use of bioprosthesis heart valves (in alphabetical order) include: 

    • angina
    • cardiac arrhythmias
    • endocarditis
    • heart failure
    • hemolysis
    • hemolytic anemia
    • hemorrhage, anticoagulant/antiplatelet-related
    • leak, transvalvular or paravalvular
    • myocardial infarction
    • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
    • prosthesis regurgitation
    • stroke
    • structural deterioration (calcification, leaflet tear, or other)
    •  thromboembolism
    •  valve thrombosis

    It is possible that these complications could lead to:

    •  reoperation
    •  explantation
    •  permanent disability
    •  death
  • Trifecta GT

    TRIFECTATM VALVE WITH GLIDETM TECHNOLOGY (GT)
    INDICATION FOR USE


    The TrifectaTM Valve with GlideTM Technology is intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.

    CONTRAINDICATIONS

    None known.

    WARNINGS

    • For single use only. Do not reuse or resterilize. Attempts to resterilize the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not oversize. Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. If the native annulus measurement falls between the two valve sizes, use the smaller size valve. Use only the Model TF2000 TrifectTM Sizers for sizing the valve. Implantation of an oversized valve may result in stent deformation, valvular incompetence, valve damage, diminished tissue durability, and/or damage to the surrounding tissues.
    • Passage of a diagnostic catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
    • Accelerated deterioration of the valve may occur in:
      • Children, adolescents, or young adults
      • Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
      • Individuals requiring hemodialysis
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
      • The expiration date has elapsed.
      • The tamper-evident jar seal is damaged, broken, or missing or if fluid is leaking from the packaging.
      • The storage solution does not completely cover the valve.
    • Use only the TrifectaTM Model TF2000 sizers1 for sizing the valve.
    • The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.

    PRECAUTIONS

    • Safety and effectiveness of the valve has not been established for the following specific populations:
      • Patients who are pregnant
      • Nursing mothers
      • Patients with chronic renal failure
      • Patients with aneurysmal aortic degenerative conditions (e.g., cystic medial necrosis, Marfan’s syndrome)
      • Patients with chronic endocarditis
      • Patients requiring pulmonic or tricuspid valve replacement
      • Children, adolescents, or young adults
    • Sizer sets are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
    • Do not place the non-sterile exterior of the valve jar in the ssterile field.
    • Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
    • Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped,  the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline  used to irrigate the valve.
    • Do not add antibiotics to either the valve storage solution or the rinse solution.
    • Do not apply antibiotics to the valve.
    • Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
    • Do not implant the valve without thoroughly rinsing as directed.
    • Position the valve so that the stent posts do not obstruct the coronary ostia or come in direct contact with the aortic wall.
    • Never handle the leaflet tissue.
    • Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact,  thoroughly flush any skin exposed to the solution with water. In case of contact with eyes with water and seek appropriate medical care.
    • Use caution when placing sutures through the  sewing cuff to void lacerating the valve tissue.  If a valve is damaged, the valve must be replaced.
    • Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
    • Do not attempt to repair a valve. Damaged valves must not be used.
    • Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve.
    • Use caution when tying knots to avoid bending  the stent posts.

    ADVERSE EVENTS

    The TrifectaTM Valve with GlideTM Technology is based upon the TrifectaTM Valve design. Therefore, a previous clinical investigation of the TrifectaTM Valve supports the safety of the TrifectaTM Valve with GlideTM Technology. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta valve in the aortic position at 31 investigational sites in the United States (18), Canada (7), and Europe (6). Data are presented on the one thousand and fourteen (1014) subjects who met eligibility criteria. The cumulative follow-up for all subjects was 924.18 patient-years with a mean follow-up of 0.91 years (SD = 0.49 years, range 0 - 2.38 years).

    Adverse events potentially associated with the use of bioprosthetic heart valves include:

    • angina
    • cardiac arrhythmias
    • endocarditis
    • heart failure
    • hemolysis
    • hemolytic anemia 
    • hemorrhage
    • leak, transvalvular or paravalvular
    • myocardial infarction
    • nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
    • prosthesis regurgitation
    • stroke
    • structural deterioration (calcification, leaflet tear, or other)
    • thromboembolism
    • valve thrombosis

    It is possible that these complications could lead to:

    • reoperation
    • explantation
    • permanent disability
    • death

    See the Clinical Study section of these instructions for adverse event data collected in the TrifectaTM Valve clinical investigation.

    1. TF2000 sizers are included in sizer set models TF2000 and TF2000-2.

  • Regent

    SJM REGENTTM MECHANICAL HEART VALVE
    INDICATION FOR USE


    The SJM RegentTM Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

    CONTRAINDICATIONS

    The SJM RegentTM Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

    WARNINGS

    • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
    • Do not use if:
      • The valve has been dropped, damaged, or mishandled in any way.
      • The expiration date has elapsed.
      • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
    • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
    • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM RegentTM Mechanical Heart Valve sizes, use the smaller size SJM RegentTM Mechanical Heart Valve.
    • Use only St. Jude MedicalTM mechanical heart valve sizers.
    • The outer tray is not sterile, and should not be placed in the sterile field.
    • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
    • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude MedicalTM leaflet tester to gently test valve leaflet mobility.
    • Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
    • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
    • Use only the valve holder/rotator packaged with the SJM RegentTM Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
    • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM RegentTM Mechanical Heart Valve can be rotated.
    • Do not pass catheters or other instruments through St. Jude MedicalTM mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
    • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

    PRECAUTIONS

    • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
    • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM RegentTM Mechanical Heart Valve.
    • Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
    • To avoid structural damage, the valve must be rotated in the fully closed position.
    • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
    • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

    POTENTIAL ADVERSE EVENTS

    Complications associated with replacement mechanical heart valves include, but are not limited to:

    hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

    Any of these complications may require reoperation or explantation of the device.

  • Amplatzer PFO

    AMPLATZERTM PFO OCCLUDER
    INDICATION FOR USE


    The AMPLATZERTM PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

    CONTRAINDICATIONS

    • Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
    • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
    • Patients with anatomy in which the AMPLATZERTM PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
    • Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
    • Patients with active endocarditis or other untreated infections.

    WARNINGS

    • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO Closure following standard of care.
    • Do not use this device if the sterile package is open or damaged.
    • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
    • Patients who are allergic to nickel can have an allergic reaction to this device.
    •  This device should be used only by physicians who are trained in standard transcatheter techniques. 
    •  Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
    • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
    • Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7. 

    PRECAUTIONS

    • The safety and effectiveness of the AMPLATZERTM PFO Occluder has not been established in patients (with):
      • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
      • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
      • Unable to take antiplatelet therapy
      • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
      • Acute or recent (within 6 months) myocardial infarction or unstable angina
      • Left ventricular aneurysm or akinesis
      • Mitral valve stenosis or severe mitral regurgita- tion irrespective of etiology
      • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation 
      • Mitral or aortic valve vegetation or prosthesis
      • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
      • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
      • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
      • Uncontrolled hypertension or uncontrolled diabetes mellitus
      • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
      •  Arterial dissection as cause of stroke
      • Index stroke of poor outcome (modified Rankin score greater than 3)
      • Pregnancy at the time of implant
      •  Multi-organ failure
    • Use on or before the last day of the expiration month that is printed on the product packaging label.
    • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
    • The AMPLATZERTM PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
    • Store in a dry place.
    • Pregnancy – Minimize radiation exposure to the fetus and the mother.
    • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

    ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus Allergic drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vessel perforation

  • Amplatzer Septal Occluder

    AMPLATZERTM SEPTAL OCCLUDER AND DELIVERY SYSTEM
    INDICATION FOR USE


    The AMPLATZERTM Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

    CONTRAINDICATIONS

    The AMPLATZERTM Septal Occluder is contraindicated for the following:

    •  Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery. 
    •  Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
    •  Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
    •  Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi). 
    • Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
    •  Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

    WARNINGS

    • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
    • Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
    • Use on or before the expiration date noted on the product packaging.
    •  This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
    • Do not use the device if the packaging sterile barrier is open or damaged.
    •  Do not release the AMPLATZERTM Septal Occluder from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device inter- feres with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment. 
    •  Implantation of this device may not supplant the need for CoumadinTM in patients with ASD and paradoxical emboli.
    • The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
    •  Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do not inflate the balloon beyond the cessation of the shunt (such as, stop-flow). DO NOT OVERINFLATE.
    •  Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at increased risk of erosion.
    •  Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.

    PRECAUTIONS

    • The use of this device has not been studied in patients with patent foramen ovale.
    •  Use standard interventional cardiac catheteriza- tion techniques to place this device.
    •  Placement of the AMPLATZERTM Septal Occluder may impact future cardiac interventions, for ex- ample transeptal puncture and mitral valve repair.
    • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
    • MR Conditional to 3.0 Tesla
      Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical testing, the AMPLATZERTM device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118 μT. The AMPLATZERTM device should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla. In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events may occur during or after a procedure placing this device may include, but are not limited to:

    Air embolus; Allergic dye reaction; Anesthesia reactions; Apnea; Arrhythmia; Cardiac tamponade; Death; Embolization; Fever Hypertension/ hypotension; Infection including endocarditis; Need for surgery; Pericardial effusion; Perforation of vessel or myocardium; Pseudoaneurysm including blood loss requiring transfusion; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation

  • Amplatzer VSD Occluders

    AMPLATZERTM MUSCULAR VSD OCCLUDER
    INDICATION AND USAGE


    The AMPLATZERTM Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. High-risk anatomical factors for transatrial or transarte- rial surgical closure include patients:

    • Requiring left ventriculotomy or an extensive right ventriculotomy.
    • With a failed previous VSD closure.
    • With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”).
    • With posterior apical VSDs covered by trabeculae.

    CONTRAINDICATIONS

    The AMPLATZERTM Muscular VSD Occluder is contraindicated for the following:

    • Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
    • Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
    • Patients with perimembranous (close to the aortic valve) VSD
    • Patients with post-infarction VSD
    • Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis.)
    • Patients with sepsis (local/generalized)
    • Patients with active bacterial infections
    • Patients with contraindications to antiplatelet therapy or agents

    WARNINGS

    • The AMPLATZERTM Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques.
    • Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon. 
    • Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
    • Use on or before the last day of the expiration month noted on the product packaging.
    • The device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
    • Do not use the device if the packaging sterile barrier is open or damaged.
    • Do not release the AMPLATZERTM Muscular VSD Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
    • Device closure in patients who have suffered a previous thromboembolic stroke should be discussed with the patient or family. In addition, consultation with a neurologist and hematologist is suggested to determine if the benefit of device closure outweighs the risk.

    PRECAUTIONS

    Handling
    Store in a dry place.

    Sizing
    Accurate defect sizing is crucial and mandatory for AMPLATZERTM Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.

    Procedural

    • This device contains nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
    • The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
    • This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
    • Aspirin (eg, 81 mg or 325 mg) or an alternative antiplate- let/ anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional. 
    • Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
    • If TEE is used, the patient’s esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
    • Patients requiring multiple devices and/or concomitant catheterization procedures might require prolonged fluoroscopy times and multiple cineangiograms. The risks of radiation exposure (eg, increased cancer risk) should be discussed in detail with the patient or family and alternatives which do not involve radiation exposure should be reviewed.

    Post-implant

    • Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
    • Endocarditis prophylaxis should be followed according to the American Heart Association recommendations.
    • Any patient who has a residual shunt should undergo an echocardiographic evaluation of the residual shunt every 6 months until complete closure of the defect has been confirmed.
    • Patients should be instructed to avoid strenuous activity for 1 month. Strenuous activities such as contact sports prior to 1 month after implant may cause the device to dislodge and embolize.

    Use in Specific Populations

    • Pregnancy - Care should be taken to minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers - There has been no quantitative assessment of the presence of leachables from the device/ procedure in breast milk, and the risk to nursing mothers is unknown.

    MR Conditional1
    Through non-clinical testing, AMPLATZERTM devices have been shown to be MR Conditional. A patient with an implanted AMPLATZERTM device can be scanned safely immediately after placement of the device under the following conditions:

    • Static magnetic field of 3 tesla or less
    • Spatial gradient magnetic field of 720 G/cm or less
    • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

    During testing, the device produced a clinically non- significant temperature rise at a maximum MR system- reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/ receive body coil.

    MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events may occur during or after a procedure using this device may include, but are not limited to:

    Air embolus; Allergic drug reaction; Allergic dye reaction; Anemia; Anesthesia reactions; Apnea; Arrhythmia; Arterial pulse loss; Atelectasis; Bacterial endocarditis; Blood loss requiring transfusion; Brachial plexus injury; Cardiac arrest; Cardiomyopathy; Chest pain; Cyanosis; Death; Device embolization; Device fracture; Fever; Headache/ migraine; Heart block; Hypotension; Myocardial infarction; Perforation of the vessel or myocardium; Peripheral embolism; Stridor; Stroke; Subaortic stenosis; Thrombus formation on device; Vascular access site injury; Venous thrombosis; Vomiting

    1. MR Conditional as defined in ASTM F 2503-05.

This site uses cookies to improve your experience.

To find out more please read our Privacy and Cookies policy.

Ok

YOU ARE ABOUT TO LEAVE
www.structural­heart­solutions.com

You are now leaving www.structuralheartsolutions.com. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

SIGN UP

Receive updates from Abbott Structural Heart