NMT Medical, Inc. announced US FDA has granted the Pre-Market Approval (PMA) enabling commercial sale of the STARFlex cardiac septal repair implant for patients with ventricular septal defects (VSD). During a minimally invasive procedure, the STARFlex implant can be placed in the heart to close the VSD using a catheter. This avoids 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 US. 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 US market."