source: Boston Scientific Corporation

Boston Scientific Announces Acquisition of
Smart Therapeutics, Inc.
Acquisition further expands neurovascular device portfolio

NATICK, Mass., Dec. 3 -- Boston Scientific Corporation 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™ 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® 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.


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Boston Scientific Corporation

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Boston Scientific Corporation