Updated November 9, 2011 at 5:30 p.m. to reflect that the trial was conducted by a Danish team, not by Edwards Lifesciences.
Researchers cut short a trial of Edwards Lifesciences (NYSE:EW) Sapien aortic valve replacement device due to adverse events associated with the implant, according to a securities analyst.
In the Danish Staccato trial, five of 34 patients who received the Sapien implant directly into the heart through an incision between two ribs experienced kidney failure, suffered a stroke, or died, Wells Fargo Securities analyst Larry Biegelsen wrote in a note to clients.
That compares to one patient among 38 receiving traditional surgery who had a stroke.
The trial, intended for 200 low-risk patients, was spiked after 72 patients were enrolled, the San Francisco Gate reported.
Biegelsen learned of the canceled trial at the Transcatheter Cardiovascular Therapeutics meeting this week in San Francisco, he wrote.
“The STACCATO study was not sponsored by Edwards Lifesciences and it was stopped locally by the clinical events committee of the trial,” Edwards representative Sarah Huoh told MassDevice in an email. “It is a late-breaking trial scheduled for presentation at TCT on Thursday; at that time, the full results will be disclosed.”
The Sapien device won FDA pre-market approval just last week, becoming the first device enabling coronary valve replacement without open-heart surgery the FDA has given the green light to. Approval was granted for an implantation procedure through the femoral artery in the leg, and only for patients at too high a risk for open-heart surgery.
Implantation directly to the heart is generally reserved for patients whose femoral arteries are too clogged for surgeons to thread the device through to the heart.
The adverse events were likely the result of under-trained cardiologists and poor trial design, Biegelsen said.
On Monday the company announced that the FDA had granted approval to add a new profile of patients to the Partner II trial studying the next-generation Sapien XT valve. The new patient cohort has a lower risk profile for open-heart surgery than previous studies.
Some patients in the Parter II study will receive the implants directly to the heart while others will receive it through the femoral vein, according to a press release.
The data from the Partner II trial is intended to support Sapien XT’s bid for FDA review. Edwards hopes to complete enrollment for the new group of patients by the end of the year.
EW shares were down about 3 percent to $74.21 in morning trading from last night’s close at $76.28.