Tendyne™ TMVI

QUALITY TIME
SECURED

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PATIENTS BENEFIT FROM MORE TREATMENT OPTIONS

MITRAL REGURGITATION IS THE MOST COMMON VALVULAR HEART DISEASE

More patients are suffering from MR than any other valve disease, and only a small percentage of them are treated.1,*,†

  • Significant MR is 4 times more prevalent than significant aortic stenosis2,3

*Calculations are approximations made based on data from Mills J, Furlong C. CANACCORD: Biomedical Devices and Services. Nov 8, 2016 and Millennium Research Group. US Markets for Heart Valve Devices 2014. 2013;   RPUS12HV13:92; and data from Abbott (LRP 20161130; based on LBE4) and Millennium Research Group. US Markets for Heart Valve Devices 2014. 2013;RPUS12HV13:94,153.
Patients treated defined as undergoing surgery or transcatheter procedure.

SOLUTIONS ARE NEEDED BEYOND SURGERY

In one survey, almost 50% of symptomatic patients with severe MR were not candidates for mitral valve surgery due to underlying factors, including4,*:

  • Impaired left ventricle (LV) ejection fraction
  • High operative risk
  • Multiple comorbidities
  • Advanced age

For these patients most in need of intervention, medical management is not enough.

*Based on a survey of severely symptomatic MR patients in New York Heart Association (NYHA) Class ≥ II+ (n = 396); 10% had surgery the following year. The remainder had no surgery and received medical management only.

TRANSCATHETER INTERVENTIONS SAVE LIVES

Landmark COAPT data demonstrates that heart failure patients with secondary MR (grade 3+ or 4+) who remain symptomatic despite guideline-directed medical therapy experience a 33% relative risk reduction in mortality when they undergo intervention with MitraClip™ therapy.5

MR patients who would otherwise be left undertreated can benefit from novel transcatheter therapies.

MORTALITY IN MEDICAL MANAGEMENT VS MitraClip™ THERAPY and Medical Management5

WHILE TREATMENT OF MR HAS EXPANDED WITH REPAIR SOLUTIONS, MR PATIENTS REQUIRE A BROADER SOLUTION SET WITH BENEFIT-TO-RISK PROFILES THAT COVER DIFFERENT NEEDS.

Tendyne™ TMVI offers patients with severe MR who are at high surgical risk a minimally invasive transcatheter option for safe and effective mitral valve replacement.

Safety and effectiveness of the Tendyne device have not been established in pediatric patients.

MAT-2000613 v4.0 | Item approved for Global OUS use only.

References
  1. Abbott data on file.
  2. Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
  3. United States Census Bureau, 2010. Age and sex composition. Issued May 2011:1-16.
  4. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28(11):1358-1365.
  5. Mack M. COAPT: Three-Year Outcomes from a Randomized Trial of Transcatheter Mitral Valve Leaflet Approximation in Patients with Heart Failure and Secondary Mitral Regurgitation. Presented at TCT 2019.

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