Food and Drug Administration advisers voted 11-0 with one abstention yesterday that the benefits outweigh the risks of the transcatheter heart valve, which can be implanted with minimal incisions, for patients considered high-risk yet who are capable of handling surgery. The FDA isn’t required to follow the advisory panel’s advice.
Patients who used Sapien experienced double the stroke risk in the first 30 days after the implant procedure, compared with those who had open-heart surgery, FDA staff said in a June 11 report. If Sapien, which was approved in November for inoperable patients, is cleared as an alternative to surgery, FDA staff said long-term follow-up is warranted.
While the panel supported the device, “there are a number of caveats that are inescapable” Warren Laskey, temporary panel chairman and chief of the division of cardiology at the University of New Mexico School of Medicine in Albuquerque, said during the meeting.
Among the caveats are the increased stroke risk, which panel members agreed should be studied in post-approval analysis, he said.
The panel also voted 10-2 that Sapien from Irvine, California-based Edwards is safe and 12-0 that the device is effective.
Market of $2.5 Billion
The market for transcatheter valves may total $2.5 billion in the U.S., said Jason Mills, a San Francisco-based analyst with Canaccord Adams Inc. The initial FDA approval of Sapien in November boosted Edwards’s sales 67 percent in the first quarter to $122 million, Michael Mussallem, the company’s chairman and chief executive officer, said in an April 24 earnings call.
The device is meant to treat aortic stenosis. The debilitating condition is caused by a narrowing valve that restricts the ability of blood to enter the aorta, the main artery that carries blood from the heart, according to the National Institutes of Health.
“A broader indication for high-risk patients would enable multidisciplinary heart teams to choose the approach best suited to their patients’ needs,” Mussallem said in a statement after the panel’s vote. “We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis.”
The FDA may decide on approval in October if reviewers follow the same timeline they did when they cleared the valve for inoperable patients. Advisers met in July to consider the device for inoperable patients and approved it in November.
Agency staff raised concerns in the report with the way Edwards selected and categorized patients in a trial, making evaluation of the results difficult. The staff said a large imbalance of people in the surgery group withdrew from the trial or died before the procedure, creating the potential for selection bias. Almost 11 percent of patients chosen for the surgery group didn’t have an operation.
Categorizing of patients who were eligible for surgery versus those who weren’t at different trial sites also appeared to vary and 30 percent of patient enrollment was by researchers who had a financial conflict of interest, FDA staff said.
Studying high-high risk patients is difficult and while reviewers should keep potential bias in mind, Magnus Ohman, a panel member and a cardiologist at Duke University Medical Center in Durham, North Carolina, said he was satisfied with the trial results.
“I wouldn’t find a specific target here and say this is what you’ve got to do differently in the future,” Ohman said during the meeting.
The stroke rate was increased through the year of follow-up for patients who received the device through an incision in the chest compared with those who had Sapien implanted using an incision in the leg. Early research found Sapien caused more strokes in patients after a year than surgery, yet after another year stroke rates evened out, according to Edwards.
Edwards proposed a post-approval study to follow patients in the trial and to create a registry for new patients, according to the FDA. Agency staff said the patients already in the trial should be followed for at least five years.
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