Cardiology CE Mark Structural Heart

Edwards secures CE mark for Pascal tricuspid valve repair device

Dive Brief:

  • Edwards Lifesciences on Monday announced it won a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation, in which blood flows backward into the heart’s atrium rather than forward through the right ventricle and into the lungs.
  • European approval for the device comes just over a month after rival Abbott scored a CE mark for a tricuspid valve version of its MitraClip device that offers a catheter-based alternative to open heart surgery for mending leaky valves.
  • Edwards’ CE mark for Pascal in tricuspid patients is a key step forward in the company’s growth strategy targeting transcatheter treatments for mitral and tricuspid valve disease.

Dive Insight:

Following enthusiasm for transcatheter aortic valve replacement (TAVR) treatments, percutaneous procedures to address disorders of the heart’s mitral and tricuspid valves are evolving frontiers. Many patients who suffer from tricuspid regurgitation are considered at high risk for open heart surgery, making a minimally invasive approach to treating the condition an attractive option.

Pascal’s new indication in Europe is for percutaneous reconstruction of the tricuspid valve through leaflet repair. Edwards also has a CE mark for its Cardioband annular reduction approach to tricuspid valve repair.

A leader in TAVR, Edwards has projected that tricuspid and mitral valve treatments could represent a $3 billion market opportunity by 2024. However, the COVID-19 crisis forced device makers including Edwards to pause enrollment in important clinical studies while hospitals focused on combating the pandemic. Edwards in late March said it had stopped enrolling patients in its mitral and tricuspid valve pivotal trials and has since noted the procedures require a stay in the intensive care unit.

Neither Abbott’s nor Edwards’ tricuspid treatments are approved in the United States. In September, Edwards received FDA’s green light to begin a U.S. pivotal trial of Pascal in patients with severe tricuspid valve regurgitation.

In mitral valve repair, Abbott’s MitraClip has a lead on Pascal, having become commercially available in Europe in 2008 and in the United States in 2013. Edwards is just beginning to roll out Pascal for mitral repair in Europe, after receiving a CE mark for the system in February 2019.

In the United States, Edwards is evaluating Pascal in clinical trials in patients with primary mitral valve disease, stemming from the structure of the valve, and in secondary mitral valve disease, which can develop in heart failure patients when the left chamber becomes enlarged, preventing the mitral leaflets from closing normally.

The company is also working to develop a transcatheter replacement treatment, called Evoque, for the tricuspid valve. In tricuspid valve replacement, it faces competition from startup Cardiovalve, which in February won a breakthrough device designation for its technology from FDA as well as clearance to begin an early feasibility study.

Edwards also said on its first-quarter earnings call it planned to share updates on Pascal, Cardioband and Evoque at the EuroPCR meeting scheduled for this week, which was ultimately canceled.​


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