St. Jude device to close heart holes fails to stop stroke
NEW YORK. October 28. KAZINFORM St. Jude Medical Inc. (STJ)'s device to plug openings in the heart after a stroke failed to definitively prevent repeat incidents in patients under age 60 compared with non-surgical drug treatment, two studies found.
The data calls into question broader use of the procedure and the product, used for nearly two decades at a cost of about $20,000 for each of about 9,000 surgeries done yearly, Bloomberg reports.
Neither study determined that St. Jude's Amplatzer PFO Occluder significantly reduced risk of a second stroke. One, funded by the St. Paul Minnesota-based company, found the device was beneficial once researchers adjusted the data to consider different dropout rates and types of treatment. The twin reports suggest the surgery isn't a panacea for those who inexplicably suffer a stroke, and then must rely on lifelong use of blood thinners to avoid another one, doctors said.
"If there is a huge treatment effect, none of these trials have been able to show it," said Deepak Bhatt, chief of cardiology at the VA Boston Healthcare System and a professor at Harvard Medical School , in an interview.
The studies were presented independently today at the Transcatheter Cardiovascular Therapeutics conference in Miami. St. Jude fell 3.6 percent to $38.27 at the close in New York . The company has gained 12 percent this year.
The St. Jude plug, made up of two wire-mesh discs filled with a polyester fabric, is threaded into the heart via a vein in the leg, and clamped like a cuff-link through the hole. In the U.S., about 40,000 people would be potential candidates if the results were positive, said Larry Biegelsen , an analyst at Wells Fargo Securities in New York.
Anecdotal Results
"We need a definitive trial of this approach if it's going to be broadly used for PFO closure," Bhatt said in an interview at the meeting. "Anecdotally, there are patients who seem to benefit. It's unfortunate that none of the trials have been able to absolutely nail that down."
The Amplatzer plug device generates less than $100 million a year. The potential market for the heart closure device to prevent strokes is about $400 million, Biegelsen wrote in a Sept. 24 note to investors.
St. Jude will file for U.S. Food and Drug Administration approval of the device in the next month or two, said Glenn Novarro , an analyst for RBC Capital Markets in New York.
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