MitraClipTM TMVr

An Ongoing
Commitment to
Innovation

TAILORED. OPTIMIZED. PROVEN.

At Abbott, we continue to innovate with the fourth generation of MitraClip, MitraClip G4, built on the only proven mitral valve therapy with over 17+ years of experience, an extensive body of clinical evidence, and over 100K patients treated worldwide.

EXPANDED PORTFOLIO OF CLIP SIZES

MitraClip G4 now offers four Clip sizes to help tailor repair based on patient mitral valve anatomy.

  • G4 NT is the original MitraClip NT/NTR Clip size.
  • G4 XT is the equivalent of XTR, with Clip arms that are 3mm longer than G4 NT and allow for easier grasping due to better reach.**

G4 NTW and G4 XTW are the wider versions of NT and XT, respectively. They are 50% wider in the grasping area, which is where the leaflet coaptation is actually restored.**



Designed to further reduce regurgitant volume with a single clip**

TREAT MORE PATIENTS WITH MORE OPTIONS2,3

MitraClip Successfully treats a broad range of valve anatomies in real world USE1,3



Nearly 1 in 5 PATIENTS TREATED have valve anatomies considered complex3

Valve anatomies include: presence of severely degenerative leaflets, wide flail gaps or widths, calcified landing zone, wide jet, primary jet outside of A2/P2, and more.3

  • Long arm clip use was associated with improved MR reduction for severe baseline MR, smaller annular dimensions,
    larger prolapse gaps and complex disease in primary MR.

    – Cardiac Surgeon with over 10 years of MitraClip

ABILITY TO CHOOSE CLIP SIZE BASED ON MITRAL VALVE ANATOMY2,3,*

CLIP SELECTION CONSIDERATIONS

FAVORS
G4 NTW
FAVORS
G4 NT
FAVORS
G4 XTW
FAVORS
G4 XT
Leaflet Length < 9mm++  
Leaflet Length ≥ 9mm  ++
Broad Jet+ + 
Smaller Valve +  
Larger Valve+ ++

MitraClip G4 Clip Selection recommendations are based on the clinical experience of physicians. The EXPAND G4 observational study evaluates adherence to Clip Size Selection Recommendations and their associated outcomes.

MORE OPTIONS TO CONFIRM AND OPTIMIZE LEAFLET GRASPING WITH CONTROLLED GRIPPER ACTUATION (CGA)**

Controlled Gripper Actuation (CGA) provides the option to grasp leaflets simultaneously or independently, enabling the ability to confirm and optimize leaflet grasp.

New gripper
levers
Simultaneous
grasping
Independent
grasping

PREDICTABLE PROCEDURE EXPERIENCE2,**

The innovative Clip Delivery System is a highly maneuverable delivery catheter which delivers the MitraClip implant via a Steerable Guide Catheter.

PRECISION AND CONTROL FROM DELIVERY SYSTEM SPECIFICALLY DESIGNED FOR THE MITRAL VALVE**

INCREASED EFFICIENCY WITH STREAMLINED PROCEDURE*

SIMPLIFIED PROCEDURAL STEPS*
  • 40% reduction in system preparation steps
  • Simplified system deployment with reduced number of steps


“IN OUR INSTITUTE, WE HAVE NOW REDUCED DEVICE TIME TO -20 MIN.”

Echocardiographer with 6 years of MitraClip experience, commenting on MitraClip G4


 

First-in-Class Technology

The MitraClip procedure is performed using femoral venous access and real-time imaging (echocardiography and fluoroscopy), thereby avoiding cardiopulmonary bypass. The MitraClip device grasps and coapts the mitral valve leaflets, resulting in fixed coaptation (approximation) of the mitral leaflets throughout the cardiac cycle.*

  • Transcatheter beating heart procedure
  • Allows for real-time positioning and repositioning to optimize MR reduction
  • Can be used in a standard cath lab or hybrid room

MitraClip™ device features:*

  • Cobalt chromium construction
  • Polyester cover designed to promote tissue growth
  • All implants are safe under labeled MRI scanning conditions§


§ Non-clinical testing has demonstrated that the MitraClip implants are MR conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3.0 T)
Maximum spatial field gradient of 4,000 Gauss/cm (40 T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ­
2 W/kg (Normal operating mode)

MAT-2011215 v1.0 | Item approved for Global OUS use only.

References

*MitraClip G4 Instructions for Use.
** Tests performed by and data on file at Abbott.
†Data on File at Abbott.
‡ The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual’s experience and might not be representative of others.

1. Chehab BM. Contemporary Clinical Outcomes with the Transcatheter Mitral Valve Repair using MitraClip™ G4 System: Core Laboratory Echocardiographic Results in EXPAND G4 Study. Data presented at PCR Valves eCourse 2020.
2. Rottbauer WD. Contemporary Clinical Outcomes with MitraClip™ (NTR/XTR) System: Core-lab Echo Results from +1000 Patient the Global EXPAND Study. Data presented at PCR 2020.
3. Maisano F. Clip Selection Strategy and Outcomes with MitraClip™ (NTR/XTR): Evidence-Based Recommendations from the Global EXPAND Study. Data presented at PCR 2020.

 

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