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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EuroPCR 2022: Mitral replacement

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EACTS 2022: Tendyne™ vs on-pump MVR

EACTS 2022 Symposium: When can Tendyne™ TMVR be a relevant substitute for on-pump MVR?

EACTS 2022: SMV repair vs replacement

EACTS 2022 Symposium: Surgical Mitral Valve Repair versus Replacement in the Modern Era of Transcatheter Valve Interventions.

ESC 2022: How do I manage my patient with functional mitral regurgitation.mp4

ESC 2022: FMR

ESC 2022: How do I manage my patient with functional mitral regurgitation?

SES_PLV_21_11_22_LL_1015_ID125_57_Abbott.mp4

PCRLV 2021: Transcatheter mitral valve replacement

PCRLV 2021: Transcatheter mitral valve replacement: patient selection & hemodynamic stability

EACTS 2021: Transcatheter mitral valve implantation

EACTS 2021: Transcatheter mitral valve implantation: patient selection & medical management

Tendyne™: Animation

Tendyne™ Procedural Animation: Quality Time Secured

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.