NMT Medical Inc.’s StarFlex ventricular septum repair implant landed pre-market approval from the federal Food & Drug Administration.
The Boston-based company’s device is designed to be inserted into the hearts of patients with defects in the wall between the ventricular chambers.
The StarFlex implant closes the defect, preventing already-oxygenated blood from returning to the lungs before being pumped back into the body.
It’s also being studied as a possible treatment for stroke or ischemia stemming from patent foramen ovale. The results of that clinical trial are expected to be released during the fourth quarter of 2010.