TSMVR : Trans-septal Mitral Valve Replacement
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.
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?
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.
Publications
- Transseptal implantation of the HighLife self-expandable mitral valve in a patient with severe secondary mitral regurgitation and heart failure(W. Wojakowski et al.) – Polish Heart Journal
- Transcatheter Mitral Valve Implantation Using the HighLife System(M. Barbanti et al.) – JACC: Cardiovascular Interventions Vol. 10, No. 16, 2017
- The HighLife Transcatheter Mitral Valve Implantation System(R. Lange, N. Piazza) – Eurointerventions Volume 11, supplement W
- HighLife Transcatheter Mitral Valve Replacement(R. Lange, N. Piazza) – Eurointerventions Volume 12, supplement Y