Core Viewpoint - The company has successfully enrolled the first patient in the clinical trial for the ReachTactile™ robotic-assisted TAVR system, marking a significant milestone in its development and potential market entry [1][2]. Group 1: Clinical Trial Details - The clinical trial for the ReachTactile™ robotic-assisted TAVR system is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the system and its disposable surgical kit in TAVR procedures [1]. - The first patient treatment was successfully completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater Command General Hospital [1]. Group 2: Product Features and Innovations - ReachTactile™ is an internally developed robotic-assisted TAVR system that offers an innovative and cost-effective solution for TAVR treatment [2]. - The system features a modular design that is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [2]. - It includes a force sensing mechanism that provides real-time tactile feedback, aiding in instrument navigation under complex vascular conditions [2]. - The system's master-slave control layout effectively reduces the operator's radiation exposure and associated occupational health risks [2]. - Additionally, the Ethernet-based remote control functionality enables cross-regional surgical operations and training [2].
沛嘉医疗-B(09996):ReachTactile™机器人辅助TAVR系统多中心注册临床试验的首例患者治疗