MASSDEVICE ON CALL — A catheter-based procedure to close holes in patients’ hearts proved no better at preventing recurrent strokes than medication alone, according to a study published today in the New England Journal of Medicine.
Researchers compared use of NMT Medical’s StarFlex septal closure system with drug therapy against drug therapy alone, concluding that there were no statistically significant differences in stroke prevention between the 2 options for patients with patent foremen ovale, a hole between the upper chambers of the heart.
An editorial accompanying the study noted that it took 9 years for the results of the study to be made public, during which time 80,000 patients underwent PFO closure at an average price of $10,000 per procedure, according to a press release.
"Even if only half these patients were treated by this method for the purpose of preventing stroke, it would suggest that during that period of time $400 million was spent on a procedure that had no apparent benefit, to say nothing of the potential clinical risks involved," Dr Clairborne Johnston wrote in the editorial.
"The undeniable message here is that too many of these holes are being closed with an off-label procedure, but partly that is because we’ve never had a randomized trial to guide us," lead investigator Dr. Anthony Furlan added in prepared remarks.
The study, intended to demonstrate the superiority of the StarFlex system, enrolled more than 900 patients at 87 U.S. and Canadian sites over 64 months, ending in October 2008.
The StarFlex implant won FDA pre-market approval in April 2009. Boston-based NMT began analyzing its closure trial data a year later, reporting in June 2010 that the device failed to meet clinical endpoints,.
That news sent its stock plunging 79% in a single day. By August 2010, the company’s poor stock performance had drawn a 1st de-listing warning from the NASDAQ stock exchange. NASDAQ finally ran out of patience with NMT and moved to de-list the company’s stock in February 2011.
By April of that year, NMT announced that it didn’t have enough money to pay auditors and wouldn’t file an annual report with the SEC. Later that month, the company began liquidating its assets in an attempt to repay creditors. W. L. Gore & Assoc. picked up NMT’s intellectual property and assets at auction that October.
St. Jude Medical (NYSE:STJ) earlier this year announced that it met a stopping rule in its Respect trial examining whether its catheter-based Amplatzer PFO closure device can prevent "cryptogenic" stroke – or strokes with unknown causes. The study met the number of primary events to meet its protocol requirements, which in turn meant that St. Jude coul close patient enrollment.
The St. Paul-based medical device maker bought the Amplatzer technology along with AGA Medical for $1.03 billion in 2010.
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