announced that the FDA granted approval for its Tenacio pump component for its AMS 700 inflatable penile prosthesis (IPP).
The AMS 700 IPP offers a treatment option for patients with erectile dysfunction. It features three parts. The system has a pair of cylinders implanted in the penis, a pump placed in the scrotum and a saline reservoir in the lower abdomen. By squeezing the pump, the IPP inflates to hold an erection for as long as a person wants.
Boston Scientific acquired the AMS 700 IPP in its $1.6 billion buy of Endo Health Solutions in 2015. The new Tenacio pump adds automation to the system. It immediately initiates automatic deflation of the prosthesis with a single full depress of the deflation button.
According to Boston Scientific, the company engineered the pump to address unmet user needs related to pump reliability. It designed Tenacio to maximize reliability across repeated use and achieve a more streamlined inflation experience. Dedicated valve systems perform independent functions to help address stiction syndrome (otherwise known as sticky pump).
The system features a prominent grip design, elongated pump neck and a high-profile, one-press release deflation button.
Boston Scientific President of Urology, Meghan Scanlon, said the system’s design may help shorten the patient learning curve. In a LinkedIn post, she called it a win-win for patients and their doctors.”
“We are pleased to introduce the new Tenacio Pump, which is intended to help deliver a more intuitive experience for patients and simplify device usage training post-operation,” said Dr. Ron Morton, chief medical officer, urology, at Boston Scientific. “Given that urologists today are facing multiple time management challenges, this innovation may help save them time as they orient patients to their new device, potentially allowing physicians flexibility in their day to treat patients.”