NMT Medical Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant

BOSTON--(HSMN NewsFeed)--NMT Medical, Inc. (NASDAQ: NMTI ), 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.”

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