A sharply divided FDA advisory panel yesterday recommended that the watchdog agency subject high-tech replacement heart valves to its most-rigorous pre-market approval protocol, meaning the CryoValve allograft made by CryoLife (NYSE:CRY) must undergo the PMA process.
The CryoValve pulmonary valve is the only such device on the U.S. market; CryoLife won clearance via the FDA’s 510(k) program for Class II "moderate-to-high risk" devices. Class III or "high-risk" devices must to use the PMA process, which requires more clinical trial data to back the application.
The FDA’s Circulatory System Devices advisory panel voted 4-2 to recommend re-classifying what the FDA calls "more-than-minimally manipulated" allograft valves. But panel members said the data behind CryoLife’s 510(k) submission were equivalent to what would be required for a PMA, heartwire reported.
CryoLife’s PMA submission for the CryoValve "met all the requirements that we usually look for in recommending approval for a PMA device," according to Dr. Kristen Patton of the University of Washington.
"[T]his discussion would have been dead easy if CryoLife hadn’t done such a good job of actually providing data," added Dr. Magnus Ohman of the Duke University Medical Center. "But going forward we really cannot predict what’s going to happen, and therefore I think it has to stay Class III."
"Because of the stakes here," added panel chairman Dr. Richard Page of the University of Wisconsin School of Medicine & Public Health, "a level of oversight consistent with Cass III PMA is necessary."
But Dr. John Somberg of the Rush University Medical Center questioned whether a Class III label is necessary given the CryoLife experience.
"It seems to me that the 510(k) process has worked," Somberg said, according to heartwire. "So I’m unsure why, with all the problems in the world, and even reducing that to the regulatory world, we are focused in this area where I don’t see a major problem, [instead of the] many areas I have seen major problems. So I’m very loath to change what is working."
Page and other panelists said the FDA should work together to find "the least burdensome path possible for the PMA process to be undertaken and for this device to be available to patients who need it."
Wall Street shrugged at the news, sending CRY shares up 0.1% to $10.40 apiece as of about 1:20 p.m. Eastern today.