Distalmotion, a MedTech company specializing in robotic surgery, has completed clinical trials for cholecystectomy and benign hysterectomy in the US, paving the way for expanded use of its DEXTER robotic surgery system. These trials support pre-market submissions for additional indications beyond the currently authorized inguinal hernia repair. The company is also implementing product enhancements to improve surgical workflow and instrument dexterity.
This development is crucial for the surgical robotics field, particularly in the outpatient setting. The successful completion of these trials positions DEXTER to address the significant and growing demand for minimally invasive procedures like cholecystectomies and hysterectomies, which represent a combined 1.5 million procedures annually in the US. This focus on high-volume outpatient procedures aligns with the broader trend of shifting surgical care away from hospitals and towards ambulatory surgical centers and hospital outpatient departments. This shift necessitates robotics systems that are adaptable, easily maneuverable, and integrate well into existing OR infrastructure, features central to DEXTER’s design.
Distalmotion has submitted data from the NEST (cholecystectomy) and HYPER (benign hysterectomy) studies to the FDA as part of their 510(k) submissions. A clinical study for sacrocolpopexy has also commenced, further expanding DEXTER’s potential applications. Concurrent with these clinical advancements, Distalmotion is rolling out system upgrades in Europe, with US implementation planned for summer 2025, pending regulatory approval. These enhancements aim to optimize OR setup, procedural workflows, and instrument performance.
This progress signals Distalmotion’s commitment to expanding access to robotic surgery in the US. The company’s strategy of focusing on high-volume outpatient procedures with a flexible and adaptable robotic system positions them well to capitalize on the growing demand for minimally invasive surgery in these settings. The upcoming product enhancements and expanded indications could solidify DEXTER’s position as a key player in the evolving surgical robotics landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
