Vacuum device label extended for use during recovery from RP

November 2, 2006

Timm Medical said the FDA has allowed the company to extend the labeling of its Osbon ErecAid device for use in creating and maintaining erections by providing arterial blood to the penis during recovery from radical prostatectomy.

Timm Medical said the FDA has allowed the company to extend the labeling of its Osbon ErecAid device for use in creating and maintaining erections by providing arterial blood to the penis during recovery from radical prostatectomy.

Timm said the permission is the result of its close collaboration with the FDA in reviewing a significant body of scientific evidence surrounding outcomes after prostatectomy. The company cited a recently published review in which the authors concluded that pharmacologic penile rehabilitation protocols are beneficial after prostatectomy and that “…either intracavernous injections or a vacuum erection device can be recommended as a first-line option for the early postoperative months, as their mechanism of action does not require intact neural transmission.”