A man with the Tactra implant in his member can push it up for intercourse and manually pushed it down when it is not in use. The prosthesis is made of dual-layer silicone in order to give it a natural feel, with a Nitinol core for rigidity and durability.
Boston Scientific CEO Michael Mahoney in a July 24 earnings call touted the Tactra as an example of new product launches in the company’s men’s health business. He also mentioned sterilization challenges that had to be fixed — a reference to the closure of Sterigenics’ ethylene oxide medical device sterilization plant in Willowbrook, Ill.
A Boston Scientific spokesperson told MassDevice in an emailed statement that the U.S. FDA has since granted the company approval to sterilize men’s health products at another existing sterilization facility in the company’s supply chain network.
Boston Scientific is marketing the Tactra implant as providing another option for urologists to offer men suffering from erectile dysfunction, especially those with limited dexterity.
The U.S. FDA cleared the Tactra penile prosthesis in April. Boston Sci is presently selling it in the U.S., with plans to make it available in Europe, Canada, Latin America, Asia Pacific and Saudi Arabia later this year.