An international study concludes that a catheter-based procedure to
close a hole in the heart may be no better at preventing recurrent strokes than
medication alone.
SOURCE: March 15, 2012 by MassDevice
staff
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.
ONLINE SOURCE: http://www.massdevice.com/news/study-heart-hole-closure-no-better-meds-preventing-stroke-massdevicecom-call
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