Healthcare Industry News: Patent foramen ovale
News Release - January 11, 2006
NMT Medical Initiates Enrollment in MIST II Migraine Study in the United StatesClinical Trial will Evaluate the PFO/Migraine Connection
BOSTON, Jan. 11 (HSMN NewsFeed) -- NMT Medical, Inc. (NASDAQ: NMTI ) today announced that the Company has initiated enrollment in its PFO/migraine clinical study in the United States. The study, named MIST II (Migraine Intervention with STARFlex® Technology), will evaluate the safety and effectiveness of NMT's proprietary STARFlex® implant technology for the treatment and prevention of migraine headaches in patients with a Patent foramen ovale (PFO).
A PFO is a common heart defect that may be a potential risk factor for migraine headaches in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. The unfiltered venous blood may contain elements that can trigger migraines in some patients.
John E. Ahern, NMT's President and Chief Executive Officer, said, "Initiating patient enrollment in MIST II is a considerable achievement for NMT. Progress in this trial is an important step forward in defining the Company's technological and clinical research leadership in this emerging field. We believe we are the first company to enroll patients in a PFO/migraine IDE study approved by the U.S. Food and Drug Administration."
MIST II is a prospective, randomized, multi-center, controlled study. The double-blinded trial is designed to randomize approximately 600 migraine patients with a PFO to either PFO closure with NMT's STARFlex® technology or a control arm. More than 40 leading migraine headache specialists and interventional cardiologists have committed to participate in MIST II. Enrollment is currently expected to be complete by the end of 2006. Follow-up with the patients will be over a one-year period.
Stewart Tepper, MD and Mark Reisman, MD are the co-principal investigators of the MIST II clinical trial. Dr. Tepper is Director of The New England Center for Headache in Stamford, Connecticut. Dr. Reisman is Director of Cardiovascular Research at Swedish Medical Center, Seattle, Washington.
Ahern said, "Medical researchers continue to associate the PFO defect with the potential for increased risk of migraine headaches, recurrent stroke and transient ischemic attacks (TIA). NMT maintains its leadership in this emerging opportunity with five separate PFO-related trials currently underway. MIST II is the second PFO/migraine trial initiated by NMT. This pivotal trial was approved by the FDA earlier in the fourth quarter. Prior to that, NMT was the first to receive approval for and to complete enrollment in a PFO/migraine study (MIST) in the United Kingdom. MIST results are currently expected in late March or early April of 2006. In October, the Company also announced approval of MIST III, a study designed to expand data and follow-up on MIST migraine patients. With its ongoing CLOSURE I trial, the Company was the first to receive approval for and enroll patients in an IDE study in the U.S. to evaluate the safety and efficacy of the STARFlex® closure technology to prevent a recurrent embolic stroke and/or TIA in patients with a PFO. In November 2005, the Company announced that it had completed enrollment in the BEST study (BioSTAR(TM) Evaluation STudy). The BioSTAR(TM) implant represents a new generation of biological closure technologies that NMT is developing and evaluating in order to promote a more natural, rapid and complete sealing of heart defects such as PFO."
Ahern concluded, "The enthusiastic response to the Company's migraine trials suggests a large, unmet demand in the medical community. It is NMT's goal to be the first company to provide those migraine patients with a PFO- related treatment option."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops 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 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 20,000 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 MIST II, MIST, MIST III, CLOSURE I and BEST studies -- involve known and unknown risks, uncertainties or other factors which 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 complete enrollment in MIST II, the timing and ultimate outcome of any of the Company's clinical trials, and 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 "Certain Factors That May Affect Future Results" included in Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 and subsequent filings with the U.S. Securities and Exchange Commission.
Source: NMT Medical
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