NMT Medical, Inc's Catheter Device Misses Goal In Study
Published: Nov 15, 2010
CHICAGO, IL and BOSTON, MA--(Marketwire - November 15, 2010) -
The multicenter study included more than 900 patients, randomized 1 to 1 in each arm of either device closure or best medical therapy. Study patients, who averaged 46 years of age ranging from 18 to 60, had experienced cryptogenic stroke or TIA and had a PFO documented by transesophageal echocardiogram (TEE). More than half of the enrolled patients had a large or moderate shunt as a result of PFO, with nearly 40% having an Atrial Septal Aneurysm -- considered to be a higher risk patient profile.
The primary endpoint was the two-year incidence of stroke or TIA, all cause mortality for the first 30 days, and neurological mortality 31 days to 2 years. The final trial results did not demonstrate superiority of PFO closure with STARFlex® plus medical therapy over medical therapy alone. At the two-year follow up period, the recurrent event rate with STARFlex® was 5.9% versus 7.7% for best medical therapy, which is not statistically significant. The rate of recurrent stroke was approximately 3% in both arms. The effective closure rate of the procedure was 86.7%, based on review by a core laboratory, and is in line with other transcatheter closure devices. The results also demonstrated that recurrent stroke and TIA had multiple possible causes, often unrelated to paradoxical embolism.
Principal Investigators of CLOSURE I were Anthony Furlan, MD Chairman of the Department of Neurology, University Hospitals Case Medical Center, Cleveland and Mark Reisman, MD Chief Scientific Officer, Swedish Heart & Vascular Institute, Seattle.
Dr. Furlan said, "Completing CLOSURE I was a major milestone for the entire medical community. Our team of more than 160 stroke neurologists and interventional cardiologists is the first to examine the stroke/PFO connection in a randomized controlled study. The data from this study will be invaluable for helping physicians make better informed treatment decisions for their patients with cryptogenic stroke or TIA and a documented PFO. Data from CLOSURE I also will be essential for designing future studies in cooperation with the U.S. Food and Drug Administration (FDA) to better understand the connection between PFO and stroke/TIA, and for better identifying patient populations with paradoxical embolism who may benefit from PFO closure."
Dr. Reisman said, "CLOSURE I is the first randomized controlled clinical study to demonstrate measurable and meaningful results regarding the safety and efficacy of treating a PFO for the stroke and TIA indication. We look forward to analyzing the data further to refine our knowledge in this area."
Richard E. Davis, Chairman, President and Chief Executive Officer of NMT, said, "Although CLOSURE I did not satisfy its predetermined endpoints, the results of the study will help to further the understanding of PFO treatment in preventing recurrent stroke and TIA. The study was well-designed and well-executed, thanks to all of the participating clinical sites. In addition, there are a number of important CLOSURE I secondary and tertiary studies, including migraine, which we are in the process of analyzing. Currently, we are working with the FDA to evaluate our possible next steps relating to stroke/TIA and expect to have a plan relating to a potential follow-up study within the next few weeks."
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 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 embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. 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 34,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
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 Company's CLOSURE I study and potential follow-up study, its ongoing clinical trials and development programs, the Company's plans and ability to raise additional financing, the success of its new direct sales strategy, expansion of the Company's cardiovascular business and market opportunities, including stroke, TIA and any other new applications for the Company's technology or products, 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, 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, 2009, Form 10-Q for the quarter ended September 30, 2010 and subsequent filings with the U.S. Securities and Exchange Commission.
Richard E. Davis
Chief Executive Officer
NMT Medical, Inc.