- Edwards Lifesciences reported this week six-month data from an ongoing clinical trial of Pascal, its CE-marked transcatheter mitral valve repair system which the company hopes will eventually rival Abbott's MitraClip in the U.S. market.
- Of 54 patients with moderate to severe or severe mitral regurgitation (MR) at baseline, about 98% saw their MR condition improve to mild to moderate or better. And 81% saw their MR fall into the range of mild, trace, or absent, six months after receiving treatment with Pascal, the company said at the EuroPCR meeting Wednesday.
- At the 30-day mark, the major adverse events rate was about 6.5%, with one case of death but no incidence of stroke or myocardial infarction.
Despite gaining a CE mark for Pascal in February, structural heart giant Edwards remains a step behind Abbott in the U.S. mitral valve repair market. Abbott said strong demand for MitraClip, approved by FDA in 2013, contributed to the nearly 25% growth in U.S. structural heart sales it saw in the first quarter.
That demand was bolstered by an expanded indication for the device to cover patients with secondary (also called functional) mitral regurgitation, supported by a 614-patient trial with 24-month follow-up. While primary MR is related to a valve leak, secondary MR is linked to coronary heart disease-related issues. Abbott is in the process of seeking an expanded national coverage determination from CMS to reflect the broader label.
Abbott has sued Edwards in federal court in Delaware, claiming its technology infringes on five MitraClip patents.
Edwards' next step is to begin enrolling an FDA-greenlighted pivotal trial comparing Pascal to MitraClip for treatment of moderate to severe or severe functional MR in symptomatic heart failure patients, the company said this week. That study will build on yet another MR trial by Edwards, which the company said is currently enrolling patients with symptomatic primary mitral regurgitation.
Edwards further invested in valve repair opportunities when, in March, it acquired certain assets of Mitralign, a Massachusetts company developing a transcatheter annuloplasty system to treat mitral and tricuspid regurgitation.
Abbott presented 30-day data for its TriClip tricuspid repair device this week at EuroPCR, with a U.S. pivotal trial in the works. In February, Edwards launched an early feasibility study to assess the safety and performance of Pascal in tricuspid regurgitation. The company's Cardioband tricuspid valve reconstruction system received CE mark in April 2018 and is also in an early feasibility study in the U.S.