BOSTON--(BUSINESS WIRE)--NMT Medical, Inc. (NASDAQ: NMTI - News), 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, today announced that it received Pre-Market Approval (PMA) from the U.S. Food and Drug Administration (FDA) enabling commercial sale of the Company’s STARFlex® cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD). The STARFlex® implant can be placed in the heart to close the VSD using a catheter during a minimally invasive procedure, avoiding the need for the alternative treatment of open-heart surgery, which is considered a high-risk, invasive procedure.
Commenting on the FDA approval, Frank Martin, NMT’s President and Chief Executive Officer said, “The approval of STARFlex® for VSD is welcome news for NMT and our customers, along with their patients, as we can now offer this next generation implant. STARFlex® will replace our CardioSEAL® implant, which had previously received FDA approval for VSD treatment. STARFlex® features the addition of a unique self-centering mechanism, which accommodates easier implantation as well as the treatment of larger defects.”
“It will be rewarding to provide this innovative treatment option to these VSD patients, and we are excited about its commercial introduction in the United States. STARFlex® has been used in our CLOSURE I patent foramen ovale (PFO)/stroke and transient ischemic attack pivotal study and has been widely used in Europe for several years,” Martin continued. “Over the next several weeks, we will be finalizing our plans for launching the product in the U.S. market.”
VSD is an opening between the right and left ventricle in the lower chambers of the heart and is the most common type of congenital heart defect. When there is a large opening between these ventricles, a large amount of oxygen-rich (red) blood from the heart’s left side is forced through the defect into the right side. It is then pumped back to the lungs, even though it has already been filtered and refreshed with oxygen. This is inefficient, because oxygenated blood displaces blood that needs oxygen, which means the heart must pump more blood and may enlarge from the added work. In addition, high blood pressure may occur in the lungs’ blood vessels. Over time, this increased pulmonary hypertension may permanently damage the blood vessel walls and could lead to heart failure.
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 30,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
Stroke is a 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, including any statements relating to the approval and introduction of STARFlex® into the U.S. market, which 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 might cause such a difference include, but are not limited to, those discussed under the heading “Risk Factors” included in the Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company’s Annual Report Form 10-K for the year ended December 31, 2008 and subsequent filings with the U.S. Securities and Exchange Commission.
NMT Medical, Inc.
Richard Davis, 617-737-0930
Chief Operating Officer