Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter robotic surgery system in hysterectomy.
Lausanne, Switzerland-based Distalmotion received the nod for Dexter in total benign hysterectomy as well as oophorectomy, salpingectomy, and other gynecologic procedures. It marks the third approved indication in the U.S. after FDA nods for inguinal hernia repair and cholecystectomy.
Hysterectomy represents one of the highest-volume gynecologic surgeries, increasingly performed in outpatient locations. These require robotic solutions that deliver enhanced dexterity, precision and surgeon ergonomics in soft tissue procedures.
Distalmotion designed Dexter to deliver robotic benefits to more hospitals, outpatient departments and ambulatory surgical centers (ASCs). The modular, small-format, open system delivers simplicity and straightforwardness, plus more accessibility, Distalmotion says.
According to the company, Dexter can work natively with third-party 3D imaging systems, energy devices, vessel sealers and other laparoscopic devices. It features a suite of fully wristed, single-use instruments. These instruments offer dexterity, precision of movement, reliable instrument performance and lower reprocessing requirements.
For more on the wide world of surgical robotics and companies like Distalmotion, see our special report on the space.
The latest FDA clearance applies to an enhanced version of Dexter, Distalmotion says. These relate to simplifying operating room setup, streamlining procedural workflows and optimize instrument performance. It builds on the company’s growing footprint in the U.S. and Europe, which includes more than 2,000 completed procedures.
“Hysterectomy is a foundational procedure in women’s health, with over 600,0001 cases performed annually in the US,” said Greg Roche, CEO of Distalmotion. “With FDA clearance for three of the top five soft tissue procedures performed in ambulatory surgery centers — inguinal hernia, cholecystectomy, and now hysterectomy—DEXTER offers ambulatory surgery centers a right-sized solution to provide the benefits of robotic surgery in a convenient surgical setting.”
Distalmotion also continues to advance its work in gynecology through clinical trials as well. It recently completed a sacrocolpopexy (SPARO) trial and initiated its myomectomy (REAL-M) trial.
