Distalmotion
Distalmotion has been granted De Novo approval by the U.S. Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult inguinal hernia repair.
The company says this milestone marks 'another step forward' in its mission to empower robotic surgery excellence by expanding access and improving care with robotic assisted surgery in the hospital outpatient and ambulatory surgery centres (ASC's) where over 90% of surgeries are performed in the United States.
Distalmotion says it is focused on developing a robotic platform for high-volume procedures and bringing the benefits of robotic-assisted surgery to outpatient settings. The company says that in these settings, demand for cost-effective and efficient solutions is growing.
"We're excited to bring Dexter to the U.S. market and empower healthcare facilities with a robotic solution that addresses the barriers of cost, space, and workflow disruption," said Greg Roche, Distalmotion CEO. "Our goal is to enhance existing practices with robotics that support, not disrupt, the way surgical teams operate."
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William Hope, MD, Associate Professor of Surgery, UNC Chapel Hill, General Surgery Residency Program Director, New Hanover Regional Medical Center (Novant Health) added: "Inguinal hernia repair is an excellent first indication for Dexter. Access to robots for these procedures has historically been a challenge. Dexter's design will undoubtedly enable more patients to benefit from robotic assisted surgery."
The company says that Dexter can integrate into existing operating workflows, and is 'fully compatible' with current operating room equipment. Dexter is designed to be the 'surgeon's robot' that provides the physician complete control of the procedure according to Distalmotion.
Garth Jacobsen, MD, Professor of Surgery, Director of Hernia Surgery, UCSD added: "Dexter provides an open concept and the ability to transition from console to bedside seamlessly, resulting in a system that is more ergonomic and operatively efficient than current generation platforms. As a surgeon, I want the ability to use the tools and techniques that enable me to provide the best care to my patients. That's what Dexter delivers."
Ryan Broderick, MD, Associate Professor of Surgery, UCSD commented: "Dexter delivers exceptional performance and without limitations. Its open platform allows flexibility, whether in terms of the surgeon console or the option to choose your preferred vision system, stapling, and advanced energy. We are seeing the continued shift of procedures moving to the outpatient setting. The footprint and cost, both less than other solutions, enable Dexter to be the ideal robot for outpatient sites of care and those patients. Dexter is the solution for everyday surgeries and that's what the market needs."
