Tendyne™ - Patients who benefit

TENDYNE^™
MITRAL VALVE
REPLACEMENT
TRANSCATHETER MITRAL VALVE
REPLACEMENT (TMVR)

Tendyne™ TMVR System is first-in-class technology designed to eliminate Mitral Regurgitation (MR),
offering selected patients with MR (≥ grade 3) a novel option for mitral valve replacement.

PATIENTS WHO BENEFIT

MR IS THE MOST COMMON VALVULAR HEART DISEASE AND IS SIGNIFICANTLY UNDERTREATED³

More patients are suffering from MR than any other valve disease, and only a small percentage of them are treated.²*^† Significant MR is 4 times more prevalent than significant aortic stenosis.^3,4

^†Patients treated defined as undergoing surgery or transcatheter procedure.

*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.

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, including:⁵*
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.

Greater MR reduction is associated with higher survival
Real-world evidence shows a significant relationship between degree of residual MR and survival after transcatheter mitral repair.
Tendyne™ is an option for select MR patients who may benefit from MR elimination.⁶
POST-PROCEDURAL MITRAL REGURGITATION⁶
FROM UNITED STATES TVT REGISTRY

TENDYNE™ TMVR OFFERS PATIENTS WITH SEVERE MR (GRADE ≥3) A NEW OPTION FOR SAFE AND
EFFECTIVE MITRAL VALVE REPLACEMENT

When heart teams consider that conventional surgery or Transcatheter Edge-to-Edge Repair (TEER) is not indicated in patients with Primary or Secondary MR, TMVR therapy is the preferred option if the patient is deemed clinically and anatomically suitable.

Tendyne™ Mitral Valve System is indicated for the treatment of the native mitral valve without prior mitral valve intervention in patients with:

Moderate-to-severe or severe mitral valve regurgitation (MR Grade ≥3+)
A life expectancy less than 5 years
Left ventricular end systolic diameter (LVESD) size >3 cm
Left ventricular ejection fraction (LVEF) ≥ 30%
Left ventricular end-diastolic dimension (LVEDD) ≤ 7.0 cm, who do not have severe mitral annular calcification and are deemed not suitable for surgical repair or replacement by a multi-disciplinary heart team.

IDENTIFYING PATIENTS FOR TENDYNE™ THERAPY

TENDYNE™ ECHO
SCREENING GUIDEDownload

TENDYNE™ CT
IMAGING GUIDE Download

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Transcatheter Mitral Valve implant : procedural and post-procedural echo guiding

Transcatheter Mitral Valve implant

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Anatomical overview of the AV Valves

Anatomical overview of the AV Valves and structures

Screening Transmission | Mitral focus

Screening Transmission | Mitral focus

F. Maisano, M. Swaans, M. Adam. M. Weber

TriClip - AVVS 1 year 1 minute Tricuspid - Video

The most significant moments of the past year | Tricuspid focus

MitraClip - AVVS 1 year 1 minute Mitral - Video

The most significant moments of the past year | Mitral focus

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AV Valves Summit 2024 | Closing of Day 2

F. Maisano, M. Metra, M. Sitges, R. S. Von Bardeleben

Trending Controversies | AV Valves

Trending Controversies | AV Valves

R. S. Von Bardeleben, M. Sitges, D. Tchetche, M. Swaans, M. Taramasso, C. Trani, K. Gatenby, M. Adamo, M. Barreiro, A. Linke, V. Ninios, J. Odenstedt, S. Berti, N. Ajmone Marsan

Case Parade | Mitral focus

Case Parade | Mitral focus

M. Sitges, V. Ninios, J. Van der Heyden, K. Gatenby, D. Arzamendi, M. Shuvy, M. Adam

Review the Trends | Mitral focus

Review the Trends | Mitral focus

M. Metra, F. Maisano, N. Karam, R.S. Von Bardeleben, F. Bedogni, S. Samargandy

References

Tendyne™ IFU.
Data on file at Abbott.
Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005–1011.
doi.org/10.1016/S0140-6736(06)69208-8.
United States Census Bureau, 2010. Age and sex composition. Issued May 2011:1–16.
Mirabel M, Lung 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.
doi.org/10.1093/eurheartj/ehm001.
Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol. 2017;70(19):2315–27. doi.org/10.1016/j.jacc.2017.09.015.
Sorajja P, Moat N, Badhwar V, et al. Initial feasibility study of a new transcatheter mitral prosthesis: the first 100 patients. J Am Coll Cardiol. 2019;73(11):1250–1260.
doi.org/10.1016/j.jacc.2018.12.066.
Gammie JS, Chikwe J, Badhwar V, et al. Isolated Mitral Valve Surgery: The Society of Thoracic Surgeons Adult Cardiac Surgery Database Analysis. Ann Thorac Surg. 2018;106(3):716–27.
doi.org/10.1016/j.athoracsur.2018.03.086.