TaurusElite经导管主动脉瓣膜
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沛嘉医疗-B: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
Zhi Tong Cai Jing· 2025-09-26 11:49
Core Viewpoint - The company has initiated the first patient enrollment for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system, marking a significant milestone in its clinical trial process [1] Group 1: Clinical Trial Details - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital [1] Group 2: System Features and Innovations - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - Its modular and mobile design is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The system features a force sensing mechanism that provides real-time tactile feedback, aiding in instrument navigation under complex vascular conditions [1] - The master-slave control layout effectively reduces the operator's radiation exposure and associated occupational health risks [1] - The Ethernet-based remote control functionality enables cross-regional surgical operations and training [1]
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
Zhi Tong Cai Jing· 2025-09-26 11:15
Group 1 - The company Peijia Medical-B (09996) has announced the enrollment of the first patient in the clinical trial for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital, implanting a TaurusElite transcatheter aortic valve in a patient with severe aortic stenosis [1] - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] Group 2 - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - The system features a modular mobile design that fits traditional vascular intervention catheter rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The force sensing mechanism provides immediate tactile feedback, aiding in instrument navigation under complex vascular conditions, while the master-slave control layout effectively reduces radiation exposure risks for the operator [1]
沛嘉医疗-B(09996.HK):ReachTactile™机器人辅助TAVR系统多中心注册临床试验首例患者治疗
Ge Long Hui· 2025-09-26 11:03
Core Viewpoint - The company has successfully enrolled the first patient in the clinical trial for the ReachTactile™ robotic-assisted transcatheter aortic valve replacement (TAVR) system, marking a significant milestone in its development and potential market entry [1] Group 1: Clinical Trial Details - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [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 - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - Its modular and mobile design is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple devices with sub-millimeter precision [1] - The system features a force sensing mechanism that provides real-time tactile feedback, aiding in device navigation under complex vascular conditions [1] - The master-slave control layout effectively reduces radiation exposure risks for operators, enhancing occupational health safety [1] - The Ethernet-based remote control capability allows for cross-regional surgical operations and training [1]