Healthcare Industry News: atrial septal defect
News Release - October 4, 2006
NMT Medical's BioSTAR(R) Data to be Presented at the 2006 TCT Scientific SymposiumBioabsorbable Septal Repair Implant Study Results to be Presented at Late-Breaking Clinical Trials Session
BOSTON, Oct. 4 (HSMN NewsFeed) -- NMT Medical, Inc. (Nasdaq: NMTI ), announced today that detailed results from its BEST (BioSTAR® Evaluation STudy) trial are scheduled to be presented at the Late-Breaking Clinical Trials and "First Report" Investigations session at the 2006 Transcatheter Cardiovascular Therapeutics (TCT) 18th Annual Scientific Symposium in Washington, D.C. Data from the study will be presented by lead investigator, Michael Mullen, MD, Interventional Cardiologist at Royal Brompton Hospital, London, on Tuesday, October 24, 2006 at 1:30 p.m. (ET).
The multi-center BEST trial evaluated NMT's new bioabsorbable septal repair implant technology designed to provide biological closure of atrial level defects using the patient's natural healing response in subjects with patent foramen ovale (PFO) or atrial septal defect (ASD). Preliminary BioSTAR® results were presented in May 2006 at EuroPCR. The initial results demonstrated that at 30 days post implant with BioSTAR®, complete closure rate was achieved in 88.5% of the study subjects. At six months, the complete closure rate increased to 96.4%. No major safety issues were observed. As 90%-95% of the implant is absorbed and replaced with healthy native tissue, future procedural access to the left atrium may be possible. The average procedure time to close the septal defect with BioSTAR® was approximately 40 minutes.
NMT also recently announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of BioSTAR® in its pivotal investigational device exemption (IDE) PFO/migraine clinical study, MIST II. The approval was granted, in part, based on the BEST study outcomes. NMT filed for regulatory approval of BioSTAR® in Europe, which the Company expects to receive by year end.
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 cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures. NMT Medical is investigating the potential connection between a common cardiac defect called a PFO and brain attacks such as migraine headaches, stroke and transient ischemic attacks (TIAs). A PFO 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 21,000 PFOs have been closed 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 500,000 Americans experience a TIA.
The Company also serves the pediatric interventional cardiologist with a broad range of cardiac septal repair implants delivered with nonsurgical catheter techniques. For more information about NMT Medical, please visit http://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® program, regulatory approvals for the Company's products in the United States and 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, potential delays 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, 2005, Quarterly Report on Form 10-Q for the period ended June 30, 2006, and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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