|St. Jude's Amplatzer PFO Occluder.--Courtesy of St. Jude Medical|
It's been a long road for St. Jude Medical ($STJ) with its stroke prevention device, but the company is celebrating a milestone after an FDA panel recommended the product for approval.
A group of doctors by a 15 to 1 vote said that a study of St. Jude's Amplatzer PFO Occluder demonstrated "reasonable assurance" that the device is safe for use, the Star Tribune reports. The panel also voted 11-5 that the device's benefits outweigh its risks, and 9 to 7 that it is effective for its intended use.
St. Jude's device helps prevent recurring ischemic strokes in individuals who have had at least one other unexplained stroke and who have a hole between the upper chambers of their heart, or a patent foramen ovale (PFO). The product offers an alternative to traditional therapy, which consists of lifelong treatment with anti-platelet drugs or blood thinners.
"We've searched long and hard for new ways to prevent the risk of recurrent strokes in patients with a PFO, as these strokes can often be debilitating. For these patients, closure with the Amplatzer PFO Occluder is an important treatment option, and today is an important step toward approval of this technology in the United States," St. Jude CMO Dr. Mark Carlson told the Star Tribune in an email.
St. Jude has a lot to gain from FDA approval of its Amplatzer device. PFO occluders could represent an annual market opportunity of up to $350 million for the company, barring serious side effect rates, Wells Fargo analyst Larry Biegelsen wrote in a note to investors seen by the newspaper.
But PFO-closure devices also represent "one of the most controversial areas of cardiovascular devices/medicine over the past 10+ years, with strong proponents and equally strong critics," Biegelsen pointed out in his note. St. Jude's journey with Amplatzer illustrates this point.
The company picked up its stroke prevention device through its $1.3 billion acquisition of Minnesota med tech AGA Medical in 2010. St. Jude finished out a study of Amplatzer that lasted 13 years from start to finish. It took 8 years to enroll 980 patients, who were followed for about 5 years each.
FDA panel members debated the results of that trial at their recent meeting. The study failed to meet its primary endpoint of reducing the rate of stroke so only a quarter of the first 25 strokes happened in patients who had the device implanted.
But 9 individuals who received or were supposed to receive devices in the trial had nonfatal ischemic strokes 5 years after procedures, compared to 16 nonfatal strokes in the control group that did not get the device. And 4.5% of patients with the device showed serious side effects related to the implant or procedure.