Acquisition further expands neurovascular device portfolio
NATICK, Mass., Dec. 3 /PRNewswire-FirstCall/ --
Boston Scientific Corporation (NYSE: BSX) announced today that it has
completed the acquisition of Smart Therapeutics Inc., a development company
focused on self-expanding technologies for intracranial therapies. Smart
recently received approval from the U.S. Food and Drug Administration to
market the Neuroform(TM) Microdelivery Stent System as a Humanitarian Use
Device (HUD). HUD approval was required to satisfy certain conditions of the
closing of the acquisition. The Neuroform stent is now available in the U.S.
and Europe. Terms of the acquisition were not disclosed.
The Neuroform Microdelivery Stent is an ultra-thin, self-expanding nitinol
stent, which is delivered through a micro-catheter and is specially designed
to bridge the opening of "wide neck" aneurysms. Wide neck aneurysms are among
the most difficult to treat. The Neuroform stent, combined with the GDC(R)
coil, allows physicians to treat a broader range of aneurysms less invasively.
If an untreated aneurysm ruptures in an artery that feeds blood to the brain,
it can lead to stroke or death.
The Neuroform stent was first used in the U.S. at Baylor College of
Medicine and Methodist Hospital in Houston, TX in September to treat three
patients with wide neck intracranial aneurysms.
"All three patients are doing wonderfully," said Michel Mawad, M.D.,
Chairman of the Radiology Department at Baylor and Chief of Radiology Services
at Methodist. "We would not have been able to treat these cases without this
device."
Smart was founded by Arani Bose, M.D., a neuro-interventional radiologist
who believed that devices should be specifically designed to treat diseases of
the neuro-vascular system. Smart's promising clinical results from a European
study led to a CE Mark for the Neuroform stent in May. The procedures
conducted to date have demonstrated that the micro-catheter delivery system
enables physicians to place the stent in the vast majority of enrolled
patients who would otherwise have had metal clips placed on the aneurysm
during an open surgical procedure.
"Our goal was to extend the range of aneurysm morphologies that can be
treated using less-invasive, endovascular techniques," said Dr. Bose. "We
believe this exciting new device is an ideal complement to GDC coils for the
treatment of brain aneurysms."
Smart is developing other technologies including a stent to treat
narrowing of the arteries around the brain and a device that retrieves clots
that can cause strokes. While all of Smart's technologies are likely to see
their first use in the intracranial anatomy, their novel designs may find
applications in other parts of the vasculature.
"The encouraging clinical results we've seen thus far are a testament to
the outstanding work of the Smart team," said Adam Elsesser, Chief Executive
Officer of Smart Therapeutics. "We are looking forward to accelerating the
development of our technologies now that we are part of Boston Scientific."
The Neuroform stent is the latest in a series of efforts by Boston
Scientific to advance the treatment of neurovascular aneurysms. Results
released in October from the International Subarachnoid Aneurysm Trial (ISAT)
demonstrated that less-invasive endovascular treatment with detachable
platinum coils produces better outcomes for patients suffering from ruptured
brain aneurysms than neurosurgical clipping. Published in the peer-reviewed
medical journal The Lancet, the study showed that the risk of death or
significant disability at one year for patients treated endovascularly with
coils was 22.6 percent lower than for those treated neurosurgically with
clipping. Results from interim analysis of the data was so compelling that
the trial was halted early after enrolling 2,143 of the planned 2,500 patients
because the Trial Steering Committee determined it was no longer ethical to
randomize patients to neurosurgical clipping.
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties.
This press release contains forward-looking statements. The Company
wishes to caution the reader of this press release that actual results may
differ from those discussed in the forward-looking statements and may be
adversely affected by, among other things, regulatory approvals, competitive
offerings, intellectual property and other factors described in the Company's
filings with the Securities and Exchange Commission.
SOURCE Boston Scientific Corporation
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Related links:
http://www.bsci.com
CONTACT:
Milan Kofol, +1-508-650-8569, Investor
Relations, or Paul Donovan, +1-508-650-8541, Media Relations,
both of Boston Scientific Corporation
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