FDA wants reanalysis of St. Jude heart implant
An FDA panel is asking St. Jude Medical ($STJ) to take a closer look at the data on its Amplatzer heart implant after a small number of patients have developed serious complications, MassDevice reports.
Doctors have discovered erosion of cardiac structures in fewer than .1% of patients with Amplatzer implants, which are septial occluders made to seal holes in the heart's upper chambers. The condition, while rare, usually takes place in the first year of treatment, with two-thirds of affected patients developing cardiac perforation within days, according to MassDevice.
Because of the small number of patients affected during Amplatzer's more than 10 years on the market, the panel is not urging immediate action, and the members acknowledged that St. Jude has taken the trend seriously. Instead, the circulatory devices committee wants St. Jude to re-examine the data on the device for clues as to what's causing the rare but serious complications.
The panel is also recommending case-controlled, post-market surveillance that augments existing studies and has multiple outcomes, hopefully rooting out the problem causing the rare complications. St. Jude, in a statement to MassDevice, said it's confident in its current monitoring practices, but will work with the agency and whatever it decides.
St. Jude acquired the Amplatzer tech in its 2010 buyout of AGA Medical for $1.3 billion, a move that boosted the company's vascular device sales significantly, in part because of the septial occluder.
- read the MassDevice report