US OKs American Medical's prolapse repair technology:
This article was originally published in Clinica
Executive Summary
The US FDA has given American Medical Systems the all-clear to sell its minimally invasive technology for repairing vaginal prolapse. The Apogee system, which repairs vaginal vault prolapse using graft material, is designed to improve patient outcomes compared with traditional abdominal or laparoscopic techniques, said the Minnetonka, Minnesota company. Scheduled for commercial release later this year, it will join the firm's other prolapse product, the Straight-In Sacral Colpopexy system. Over 36 million women in the US and Europe suffer from vaginal prolapse, with over six million of those cases being severe, the firm added. Because current procedures are lengthy and complex, only 350,000 surgical repairs are performed annually.