|St. Jude's Amplatzer plug was found to provide no definitive benefit over drug treatment--image courtesy of St. Jude.|
The success of St. Jude Medical's ($STJ) heart plug device hinged on the idea that it helped prevent repeat strokes, but two new studies found that the Amplatzer PFO Occluder showed no definitive benefit over standard drug therapy.
The studies, unveiled Thursday at the TCT conference in Miami, looked at 12 years of data on stroke patients born with patent foramen ovale (PFO), a hole between the heart's upper chambers. Neither study found St. Jude's hole-plugging device to significantly reduce the risk of a second stroke, although the company-sponsored trial found that the Amplatzer plug was effective after adjusting the data to account for drop outs and differing treatments.
In any case, the results suggest Amplatzer isn't a cure-all for stroke patients with PFO, and St. Jude's shares dropped 3.6% to $38.27 at market close Thursday, Bloomberg reports. St. Jude is seeking FDA approval for an expanded indication for the tech, but that's not very likely in light of these study results, an analyst told the news service.
St. Jude rakes in about $100 million annually with the plug, and about 9,000 patients get the procedure each year. Doctors tend to use plugs like the Amplatzer in PFO patients who have had strokes, figuring that the passage could allow blood clots to reach the brain. Conventional wisdom began to shift in 2010, however, when an independent study found identical repeat stroke rates in patients who underwent the procedure and in those who used traditional therapies.
- read St. Jude's release
- here's the Bloomberg story