Clearance covers sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection. This marks the second clearance for Dexter in gynecology and the system’s fourth overall. Cleared gynecology procedures include hysterectomy and salpingo-oophorectomy. Its indications also include general surgery, covering inguinal hernia repair and cholecystectomy.
The company announced that it submitted Dexter for its latest indications just over two months ago.
Lausanne, Switzerland-based Distalmotion — one of 10 surgical robotics companies you need to know — 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.
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.
(Learn more about Distalmotion, Dexter and the surgical robotics space in our MassDevice Surgical Robotics Special Report. Download the report for free here.)
With its latest indications, Dexter enables ASC administrators to expand their gynecologic surgery service line. It helps to meet demand for robotics in women’s health and efficiency metrics.
The company recently secured significant funding to support its efforts to bring Dexter to ASCs. CEO Greg Roche recently spoke about the ASC push on the DeviceTalks Weekly Podcast.
In parallel with the coming commercial expansion for these procedures, Distalmotion continues to advance its clinical pipeline. It currently has Dexter under evaluation in an FDA investigational device exemption (IDE) study for myomectomy.
“Securing FDA clearance for these additional GYN indications is another important milestone for the DEXTER program,” said Greg Roche, CEO of Distalmotion. “By enabling a comprehensive GYN service line, we are empowering care teams to maximize their workflows and deliver the combined benefits of robotics and same-day care to a broader patient population.”
