Overcoming Obstacles to TMVR Device Approval

I recently contributed an article and perspective for MD+DI regarding challenges ahead for TMVR, or transcatheter mitral valve replacement. Although the technology has not seen the rapid clinical success and adoption of its cardiological cousin, TAVR, or transcatheter aortic valve replacement, I’m optimistic that developments for this technology and its clinical trials will give hope to millions of people who are unable to undergo even minimally invasive mitral valve repair. Getting there, however, will likely require medical device companies to consider these approaches:

  1. let innovation take its course
  2. secure long-term results with long-term planning
  3. preempt ambiguous results with clearly defined endpoints

If you haven’t been following this fascinating field, the promise of TMVR is of an implant that can be delivered through blood vessels to the space between the left atrium and the left ventricle, to stop mitral valve regurgitation (leaking). Related technology is available for non-surgical replacement of the aortic valve, mere millimeters away, but no transcatheter mitral valve replacement device has claimed FDA approval.

Since 2000, at least 30 devices have entered or are prepping for clinical trials in this space. Set backs are largely because of variance in the shape of the valve from patient to patient, as well as the variety of causes of valve regurgitation, neither of which are major issues with TAVR.

The former problem is largely a design issue, and medical device companies have developed several different strategies to tackle these physiological challenges.

The latter concern falls into the hands of CROs who are helping design and manage clinical trials. Successful trials that lead to approval should stratify patients between primary and secondary heart disease and screen the patients for long-term implications. The Mitral Valve Academic Research Consortium also recommends 10 clinical endpoints for all TMVR trials to clearly define study results, from mortality to functional performance and echocardiographic assessments.

If you’d like to explore the issues and challenges of TMVR and TAVR more deeply, I recommend reading Novella’s white paper, “Innovations in Heart Valve Technology.”

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