NMT Medical Inc has received pre-market approval (PMA) from the Food and Drug Administration (FDA) allowing commercial sale of the Company's CardioSEAL cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD) that are not candidates for surgical closure. The CardioSEAL implant is placed in a minimally invasive, catheter-based procedure in the cardiac catherization laboratory. The Company has obtained European approval (CE Mark) for CardioSEAL and the next generation STARFlex implants for atrial level defects.
Commenting on the FDA approval, John E. Ahern, President and Chief Executive Officer of the Company said, "This lifesaving technology treats patients that are quite ill and are not surgically treatable. It's gratifying to be able to provide treatment options to these patients."
Under conditions of the PMA approval, the Company will perform a small post-approval study to follow certain patient groups for a period of five years.
NMT Medical designs, develops and markets innovative medical devices that utilize advanced technologies and are delivered by minimally invasive procedures. The Company's products are designed to offer alternative approaches to existing complex treatments, thereby reducing patient trauma, shortening procedure, hospitalization and recovery times, and lowering overall treatment costs.'