Distalmotion announced today that it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal).
Lausanne, Switzerland–based Distalmotion already holds FDA de novo approval for Dexter for adult inguinal hernia repair. This marks the second approved indication for the surgical robot in the U.S.
“Cholecystectomy is a key procedure in general surgery, with approximately 1 million cases performed annually — of which 60% are performed in outpatient settings,” said Greg Roche, CEO of Distalmotion. “With indications for inguinal hernia repair and now cholecystectomy, we’re meaningfully building the reach of Dexter in the U.S. so that more surgical teams and patients will benefit from robotic surgery. Our mission remains focused on empowering access to robotics with the right robot for the right site of care.”
For more on the wide world of surgical robotics, see our special report on the space.
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.
The company says Dexter seamlessly integrates into existing workflows and works with current operating room equipment. The single-use instruments also remove the complexities of reprocessing to further enhance workflow efficiency. Dexter’s design enables quick, direct access to the patient from the sterile surgeon console as well. Distalmotion said it designed Dexter to be the “surgeon’s robot,” providing complete physician control for procedures.
Distalmotion says Dexter’s use cases now total 2,000. They range across more than 30 procedure types in general, gynecological, colorectal and urological surgery. The company continues to expand access to its surgical roobt, completing its pivotal HYPER study for benign hysterectomy. It also has enrollment ongoing in its sacrocolpopexy clinical trial.
