TSMVR : Trans-septal Mitral Valve Replacement

An Overview of the Innovative HighLife TSMVR Solution

What is the HighLife TSMVR Solution?

This breakthrough investigational treatment is intended for adult patients suffering from moderate to severe symptomatic Mitral Regurgitation, whether primary or secondary, who are considered to be at high surgical risk and therefore not viable candidates for other therapies such as transcatheter mitral valve repair or surgery.

CAUTION: INVESTIGATIONAL DEVICE, FOR CLINICAL INVESTIGATIONS ONLY.

Technology

The HighLife TSMVR is a dual component system consisting of a bovine pericardial valve and a ring that sits below the native mitral valve. Upon delivery, the valve centers itself inside the ring and finds equilibrium with this sub-annular component in a stable position.

HighLife Valve is an investigational device and is not for sale in any geography.

The HighLife valve is available in two configurations: either as a standard valve or as a Clarity valve. The Clarity valve specifically targets patients with LVOT (Left Ventricular Outflow Tract) obstruction risk. It is currently being tested in feasibility studies around the world.

How does it work

What are the advantages of the HighLife TSMVR Solution?

HighLife's unique solution design enables:
Self-centering and self-aligning valve
Allowing an easy and safe delivery
Respect for Patient anatomy
Atraumatic for the patient thanks to its unique design
Efficient Sealing
Prevents paravalvular leaks from occurring thanks to the unique valve in ring concept
Adapting to Every Patient
The valve can be implanted in a wide range of native annuli
Stepwise procedure
A step-by-step procedure designed for operators to follow in a controlled and sequential way

Physician Feedback

Check these videos to learn more about physicians’ experience with HighLife devices and procedure

  • Prof. Z. Huczek – Poland

    Prof. Zenon Huczek from Medical University of Warsaw shares his feedbacks on treatment options for MR patients, and his experience with HighLife procedure and outcomes for the patients.
  • Dr. D. Tchétché – France

    Dr Didier Tchétché from Clinique Pasteur – Toulouse shares his experience with the HighLife devices and procedure.
  • Prof. C. Dubois – Belgium

    Prof. Christophe Dubois from UZ Leuven discusses the cases performed and successful outcomes of his patients.
  • Prof. S. Worthley – Australia

    Prof Stephen Worthley from Macquarie Hospital University in Sydney describes the procedure, proctoring experience and results he has witnessed.

Clinical Trials

The HighLife TSMVR solution is currently being validated through a number of clinical trials conducted world-wide. Learn more about our clinical trials.

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