FDA Grants PMA for NMT's StarFlex

April 9, 2009—NMT Medical, Inc. (Boston, MA) announced that the US Food and Drug Administration (FDA) has granted premarket approval for the commercial sale of the company's catheter-based StarFlex cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD).

According to NMT, the StarFlex is the company's next-generation VSD-repair implant device, replacing its CardioSeal implant. StarFlex features the addition of a unique self-centering mechanism, which accommodates easier implantation as well as the treatment of larger defects. StarFlex has been used in its CLOSURE I patent foramen ovale/stroke and transient ischemic attack pivotal study and has been available in Europe for several years. Plans for the US market product launch will be finalized in the next several weeks, the company stated.