St. Jude's heart-plug future hinges on study data

St. Jude faces boom-or-bust study results for its Amplatzer plug--courtesy of St. Jude

St. Jude Medical ($STJ) pulls in about $100 million a year with its Amplatzer heart plug, often used to close up holes in the heart after a stroke, but a soon-to-be-released study could prove the procedure to be meaningless, Bloomberg reports.

One in 5 adults are born with patent foramen ovale--a hole between the heart's upper chambers--and while the condition is generally harmless, doctors tend to use plugs like the Amplatzer in patients who have had strokes, figuring that the passage could allow blood clots to reach the brain.

The new study, to be released this week, takes a look at whether that's actually the case, using between 9 and 12 years of data, according to Bloomberg. If the procedure has little effect on repeat strokes, Amplatzer sales are likely to plunge, but if the data points in the other direction, St. Jude is set for a huge boon, the news service reports. Right now, the device isn't indicated for stroke prevention in the U.S., and positive results would support a potentially lucrative FDA application, the company told Bloomberg.

Physicians remain divided on the issue in light of a 2010 study that kicked off the speculation, finding identical repeat stroke rates in patients who underwent the procedure and those who used traditional therapies.

Right now, about 9,000 patients get the procedure each year, but that number could skyrocket with positive results and an expanded indication, Wells Fargo analyst Larry Biegelsen told Bloomberg. Biegelsen estimates the potential market for heart-closure devices at $400 million.

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Correction: An earlier version of this story featured an incorrect photo. We regret the error.