Healthcare Industry News: atrial septal defect
News Release - June 28, 2007
NMT Medical Receives CE Mark Approval for BioSTAR(R)Market Launch of New Bioabsorbable Implant Closure Technology is Expected in the Third Quarter of 2007
BOSTON--(HSMN NewsFeed)--NMT Medical, Inc. (Nasdaq: NMTI ) announced today that it has received CE Mark approval in Europe for its BioSTAR® bioabsorbable septal repair implant technology and Rapid Transport(TM) delivery system. The CE Mark is required in order to commercialize a product in the European Union and other select countries.
NMT's President and Chief Executive Officer John E. Ahern said, "Receiving CE Mark approval for BioSTAR® in Europe is an important achievement for NMT and we are enthusiastic about the potential impact of our bioabsorbable implants. BioSTAR® also recently received Canadian regulatory approval and we anticipate initiating a market launch for BioSTAR® in both Europe and Canada early in the third quarter. Our first priority will be to accommodate the doctors currently using our STARFlex® implant, as well as their patients, who have been eagerly awaiting the BioSTAR® launch. In addition, BioSTAR® has been approved for use in MIST II, our pivotal patent foramen ovale (PFO)/migraine trial in the U.S."
BioSTAR® is designed to provide biological closure of atrial level defects using the patient's natural healing response. Data has shown that 90 to 95% of the implant is absorbed over time and replaced with healthy native tissue. The clinical data from the prospective multi-center BEST (BioSTAR® Evaluation STudy) trial, published in the October 2006 edition of the peer-reviewed journal Circulation, demonstrated that BioSTAR® provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months.
"BioSTAR® represents the first implant in a new generation of bioabsorbable technologies that NMT is developing in order to improve the treatment of structural heart disease," said Ahern. "As demonstrated by the BEST clinical trial, we believe the unique biomaterial, drug and device combination used in BioSTAR® enhances positive septal closure outcomes.
We currently believe that receiving the CE Mark further underscores the advanced design and proven effectiveness of BioSTAR®. We continue to remain focused on strengthening NMT's leadership position in this field by bringing to market the most innovative and technologically advanced products."
The BioSTAR® bioabsorbable septal repair implant will be offered in three sizes: 23mm, 28mm and 32mm. Equipped with the latest available Rapid Transport(TM) delivery system, the average procedure time to close a septal defect with BioSTAR® is approximately 40 minutes. BioSTAR® incorporates a purified acellular collagen matrix delivered on the proven STARFlex® alloy framework. The collagen used in BioSTAR® also is a platform for timed release of biological response modifiers (genes, cells, proteins and drugs). An elutable heparin substrate has been included in the BioSTAR® design and provides a means to minimize the thrombus formation that occasionally occurs in all intra-cardiac devices.
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT Medical is currently investigating the potential connection between a common heart defect that allows a right to left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as migraine headaches, embolic stroke and transient ischemic attacks (TIAs). A common right to left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 24,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
The prevalence of migraines in the United States is about 10%. Of the 28 million migraine sufferers in America, those who experience aura and have a PFO may represent a three million patient subset. Stroke is the third leading cause of death in the United States and the leading cause of disability in adults. Each year, 750,000 Americans suffer a new or recurrent stroke and an additional 500,000 Americans experience a TIA.
For more information about NMT Medical, please visit www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements - including statements regarding the BEST and MIST II trials, the Company's BioSTAR® programs, regulatory approvals for the Company's products in the United States, Europe and elsewhere abroad, and the Company's investment in product development - involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company's ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the year ended December 31, 2006, Quarterly Report on Form 10-Q for the period ended March 31, 2007 and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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