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| Edwards' Fortis mitral transcatheter heart valve--Courtesy of Edwards |
Edwards Lifesciences ($EW) reports initial success with the first three human implants of its Fortis mitral transcatheter heart valve. Good news is crucial here if the California company is to succeed in both diversifying and broadening its market-leading presence in the transcatheter valve-replacement space.
Those surgeries took place in both February and early March at St. Thomas' Hospital in London. Each patient had major mitral valve disease and would have faced significant risks through conventional surgery, the company said. Fortis is built with treated bovine pericardial tissue (Edwards said it is its most advanced), and it is implanted with a transapical approach (an incision under the left breast to access the arteries). The valve also features a cloth-covered self-expanding frame, which Edwards said helps to minimize paravalvular leak.
Fortis remains investigational, and much more testing is in the cards in the months and years to come. But Michael Mussallem, Edwards' chairman and CEO, said in a statement that he sees mitral valve disease as an underserved segment that's ripe for attention.
"We believe mitral valve disease is undertreated worldwide and there is a particular need among patients who are too high risk to benefit from traditional surgical options," Mussallem said. "Although durable success will not be known without significantly more experience and longer term follow up, we are excited about this potential opportunity that we believe may be very meaningful for patients."
Other companies agree. Italy's Sorin Group, for example, invested in 2012 in HighLife SAS, a French startup developing a transcatheter replacement system to treat mitral regurgitation. And CardiAQ Valve Technologies is developing a transcatheter mitral valve replacement system as an alternative to surgery.
Edwards recently won a CE mark in Europe to use its Sapien XT transcatheter heart valve for valve-in-valve procedures to replace their surgical mitral or aortic valves and face risk from conventional surgery. This valve can be used for transfemoral, transapical and transaortic procedures.
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