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| Second-generation CoreValve TAVR--Courtesy of Medtronic |
Analysts said Edwards Lifesciences ($EW) widened the lead over Medtronic with the FDA approval its Sapien 3 TAVR, but the industry bigwig struck back just days later, receiving approval of a second-generation version of its own TAVR, the CoreValve Evolut R.
The approval shows the FDA is serious about approving devices faster, at least in the case of transaortic valve replacements for high-risk patients, many of whom are ineligible for open heart surgery. The approval comes four months after it earned a CE mark; that's compared to a 7-year lag for the original CoreValve, which was FDA-approved in 2014.
As in the case of Edwards' Sapien 3, the FDA's approval of the Evolut R came faster than expected. Leerink analysts predicted it would come 6 months after the Sapien 3 decision, not a week later.
Leerink analysts said the approvals mean Edwards and Medtronic now have a 2-3 year lead over Boston Scientific's Lotus and St. Jude's Portico, which have CE marks, but not FDA approval. They continue to view the Sapien 3 "as a best-in-class valve and the likely market leader."
Medtronic told FierceMedicalDevices that the two competing devices have roughly even market share in Europe, where they've faced off since February, citing BibaMedTech Insights.
The Evolut R is a repositionable TAVR, while Edwards told FierceMedicalDevices that the Sapien 3 is not, giving it a possible advantage. Since it's repositionable, the latest generation of CoreValve can be retrieved and moved in reverse using its revamped delivery catheter once the valve is initially positioned, allowing cardiologists to make minor adjustments, resulting in fewer complications like paravalvular leak.
During the Evolut R's CE mark trial, the feature was used in one-fourth of the patients to give the doctor "a second shot at things," Dr. Ian Meredith of Australia's MonashHeart medical clinic, who's also a consultant for Medtronic ($MDT), told FierceMedicalDevices in a previous interview.
Other new features of the device include an extended sealing skirt on the 26mm and 29mm valve sizes, "intended to further promote valve sealing at the annulus." The sealing skirt is valve tissue that extends to the bottom of the valve.
The 23mm version "is most often implanted into a failed aortic bioporsthesis valve (valve-in-valve replacement) where an extended skirt is not necessary," the company told FierceMedicalDevices. In fact, CoreValve was the first platform to get an expanded indication from the FDA for the replacement of patients' failed artificial aortic valves. Edwards does not yet have permission do so in the U.S.
During the CE mark study of the Evolut R, patients who would have had a 7% of chance of dying within 30 days if they received open heart surgery had a 100% survival rate after 30 days.
But the results also reflect the effectiveness of all TAVRs as a new paradigm for treating heart failure. They deliver transaortic valve replacements via a catheter often inserted through the thigh, replacing invasive open heart surgery. "I think the future is that everyone who needs a valve will get a transcatheter valve," Dr. Catherine Otto, an echocardiologist at the University of Washington who doesn't do the procedure, recently told the The New York Times. "It's going to become the standard."
Indeed, FDA's enthusiasm for TAVRs bodes well for companies trying to enter the U.S. market, like St. Jude Medical and Boston Scientific, as well as for expanded indications among the two established devices for use in intermediate-risk patients.
- read the release
Editors Note: The statistic about the device's European market share was corrected to say it is roughly even with the Sapien 3.