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| Edwards Lifesciences' Sapien XT valve has been available overseas for years but has yet to win FDA approval.--Courtesy of Edwards Lifesciences |
Around the world, thanks to the CE mark, cardiologists are treating patients with cutting-edge, life-saving devices like Medtronic's ($MDT) CoreValve and Edwards Lifesciences' ($EW) Sapien XT. Meanwhile, in the U.S., physicians are stuck with using first-generation implants as they wait through the FDA's rigorous--and time-consuming--approval process.
As Reuters reports, many cardiologists are frustrated with the delay as they watch next-generation devices report stellar results in patients overseas. Transcatheter aortic valve replacement, a less-invasive procedure, has changed the game in interventional cardiology, but, in the U.S., only Edwards' first-generation Sapien is approved, and well-performing devices like the CoreValve and Boston Scientific's ($BSX) Lotus are likely years away from stateside use.
And the lag in approval times has slashed the revenues of medical device companies, which have lost hundreds of millions in would-be sales, Reuters notes, not to mention the considerable cost of funding large-scale, FDA-targeted clinical trials.
In response, most large manufacturers begin their clinical operations overseas, working toward a CE mark so that they can get some return on investment before diving into the FDA process. And while that makes business sense, from the cardiologists' perspective, the Europe-first model only further delays the U.S. availability of the latest therapies.
The FDA, for its part, has committed to moving the system along without compromising its world-class standards for safety and effectiveness. The agency has recently launched a modular approval program, in which devicemakers report data incrementally to speed up the investigation process. Furthermore, as part of its latest user fee agreement, the agency has agreed to review and decide on 80% of PMA applications within 180 days of filing and 93% of 510(k)s within 90 days.
However, in the short term, cardiologists still face the frustration of treating patients with now-dated technology while knowing there are more effective and just-as-safe options available elsewhere, and, when dealing with heart disease, it's hard to exaggerate the importance of time, Columbia University cardiologist Martin Leon told Reuters.
"With this disease, if you wait two or three years, 60% or 80% of (patients) are dead," Leon said. "So not to have the most updated version of the device to treat more patients like this doesn't seem to be a particularly good idea."
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