A Medical Device Daily
NDO Surgical (NDO; Mansfield, Massachusetts) reported that the FDA has cleared its Plicator II multiple implant technology. Plicator II technology offers improved outcomes for harder-to-treat gastroesophageal reflux disease (GERD) patients, according to the company.
NDO said that FDA clearance of the Plicator technique was based on a review of a multi-center, 40-patient clinical trial in which 80% of treated patients experienced superior GERD symptom control at six-months post-treatment. About 70% of treated patients recorded six-month GERD health-related quality-of-life scores that were better than the scores recorded while patients were being treated for GERD with proton pump inhibitor medications.
“This clearance and the subsequent launch of next-generation Plicator technology strengthen our global leadership position in endoscopic, anti-reflux surgery,” said Bernard Haffey, president/CEO of NDO.
NDO makes flexible endoscopic technologies that enable surgical procedures through the body’s natural openings.