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SURGICAL HEART VALVES

MECHANICAL HEART VALVES CLINICAL DATA

Unique design features have established Abbott mechanical heart valves—including the Regent™ and Masters Series—as a gold standard for reliability and performance, while maintaining low complication rates over the long term.

Clinical Data

DEMONSTRATED SAFETY OVER NOTABLY LONG-TERM STUDIES

Abbott mechanical heart valves deliver exceptional hemodynamics and performance while maintaining low complication rates over the long term. The Abbott mechanical heart valves have demonstrated low mortality rate and a low incidence of valve-related events over a period of at least 30 years.^1,2

Saito³

	Aortic Valve Replacement	Mitral Valve Replacement
Retrospective Study	950 patients, 30 years	1,255 patients, 30 years
Thromboembolism	0.56%/pt-year	0.99%/pt-year
Thrombosis	0.02%/pt-year	0.03%/pt-year
Bleeding Event	0.27%/pt-year	0.43%/pt-year

READ THE SAITO ABSTRACT

Johnson⁴

	Aortic Valve Replacement	Mitral Valve Replacement
Retrospective Study	584 patients, 30 years	439 patients, 30 years
Thromboembolism	1.7%/pt-year	2.9%/pt-year
Thrombosis*	0.2%/pt-year	0.1%/pt-year
Bleeding Event	2.4%/pt-year	2.0%/pt-year

*Calculated values.

READ THE JOHNSON ABSTRACT

MAT-2115558 v3.0 | Item approved for U.S. use only.

References

Pibarot P, Dumesnil JG. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000;36(4):1131-1141. doi.org/10.1016/s0735-1097(00)00859-7
Bach DS, Sakwa MP, Goldbach M, et al. Hemodynamics and early clinical performance of the St. Jude Medical Regent mechanical aortic valve. Ann Thorac Surg. 2002;74(6):2003-2009.
Saito S, Tsukui H, Iwasa S, et al. Bileaflet mechanical valve replacement: an assessment of outcomes with 30 years of follow-up. Interact Cardiovasc Thorac Surg. 2016;23(4):599-607. doi: 10.1093/icvts/ivw196
Johnson S, Stroud MR, Kratz JM, et al. Thirty-year experience with a bileaflet mechanical valve prosthesis. J Thorac Cardiovasc Surg. 2018;157(1):213-222. doi: 10.1016/j.jtcvs.2018.09.002

Important Safety Information

Important Safety Information

Regent
MASTERS SERIES

Rx Only
REGENT™ MECHANICAL HEART VALVE
INDICATION FOR USE

The SJM Regent™ 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 valve.
CONTRAINDICATIONS

The SJM Regent™ Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.
POTENTIAL ADVERSE EVENTS
Complications are 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, heart failure or death. Any of these complications may require reoperation or explantation of the device.
Rx Only
MASTERS SERIES MECHANICAL HEART VALVE
INDICATION FOR USE

The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.
CONTRAINDICATIONS
The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.
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, failure or death. Any of these complications may require reoperation or explantation of the device.