Coronary Occlusion

HANGZHOU, China, Sept. 5, 2024 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. (Venus Medtech, 02500.HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced that its in-house developed next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system, Venus-Vitae, successfully completed two inaugural implantations as part of its global multicenter pivotal trial, Venus-Vitae SMART-ALIGN, at Prince of Wales Hospital in Hong Kong, China. Continue Reading These successful implantations mark another leap forward for the company into the frontier of next-generation dry-tissue valves, representing a significant addition to our transcatheter heart valve solutions. Following the first two successful implantations, Venus-Vitae SMART-ALIGN pivotal clinical trial will be progressively launched at around 20 centers in Europe, North America and China, enrolling a total of 150 patients. The trial data will be used to support registration applications in the EU, Canada, China and other territories. The procedures were performed by Prof. So Chak Yu Kent and the team at Prince of Wales Hospital in collaboration with Prof. Scott Lim of University of Virginia Medical Center, supported by a multidisciplinary team from Ultrasound, Anesthesiology, and Imaging Departments. Both patients received 23mm Venus-Vitae implants. The procedures presented good immediate post-operative results with significant hemodynamic improvement. Venus-Vitae Smart-ALIGN, abbreviated from Multicenter Pivotal Study to Evaluate the TreatMent of Severe AoRTic VALve StenosIs UsinG the VeNus-Vitae Transcatheter Heart Valve System, is a prospective, multicenter, non-randomized interventional study to evaluate the safety and efficacy of the Venus-Vitae TAVR system in patients with severe aortic stenosis. "Recently, my colleague Dr. Michael Hainstock and I, at the University of Virginia Medical Center, completed the first patient implantation in the VenusP-Valve PROTEUS pivotal clinical trial in the United States, " said Prof. Scott Lim." Two months later, I am very pleased to have participated with Dr. Kent So in the implantation of the first two patients in the Venus-Vitae SMART-ALIGN international multicenter pivotal clinical trial at Prince of Wales Hospital in Hong Kong. These both represent important milestones in those studies. Additionally, both the VenusP Valve and the Vitae valve have been previously used in clinical applications, with excellent published results. Of note, the Venus-Vitae valve's stent frame is the shortest among current transcatheter aortic valves, and I am encouraged by its potential to treat aortic stenosis while maintaining coronary access. Furthermore, its dry valve leaflet technology facilitated rapid preoperative preparation time. We look forward to further international enrollment in the SMART-ALIGN clinical trial in the near future." "It was an honor to collaborate with Dr. Scott Lim to complete the first two confirmatory clinical implantations of this innovative dry valve," said Prof. So Chak Yu Kent after the procedures. "Venus-Vitae's active anti-PVL technology and short frame design effectively prevent leakage and minimize the risk of coronary artery obstruction. I'm eager to see expedited enrollment of patients for Venus-Vitae, so that more patients can benefit soon." "Venus-Vitae is our next generation balloon-expandable TAVR system, with global patent coverage," said Hou-Sen Lim, General Manager and CEO of Venus Medtech. "We have strong confidence in its international multi-center clinical trials and global strategy. The successful initial implantations provide a solid foundation for forthcoming trials in Europe, North America, and China. We are committed to advancing Vitae's global clinical application and regulatory registration, bringing our cutting-edge technology to physicians and patients worldwide." About Venus-Vitae Venus-Vitae utilizes the innovative Venus-Endura technology, which integrates multiple anti-calcification techniques, immunogenicity removal technology and 3D force-controlled dehydration technology, providing exceptional durability, biocompatibility, and excellent anti-calcification performance. In addition, this design allows for room temperature storage of the valve in a dry-tissue condition. Additionally, the product features a unique patented technology, Lockwire Technology, ensuring the stability and accuracy of the valve during delivery and deployment. The short stent frame of Venus-Vitae's valve along with its steerable NAVIMASTER delivery system, significantly optimizes the performance across the aortic arch and positioning within the native valve. Venus-Vitae also features a unique Coronary Alignment technology, addressing the fundamental challenge that current TAVR products have been unable to address—aiding in protection of the coronary arteries. By utilizing three gold markers at the base of the valve leaflets in conjunction with the delivery system's steering, telescoping, and balloon rotation capabilities, Venus-Vitae can effortlessly and precisely achieve coronary alignment during the deployment process. This aids in accomplishing coronary protection throughout the implantation procedure. Furthermore, Venus-Vitae features a self-adaptive anti-PVL technology, utilizing an adaptive polymer skirt. The proprietary polymer skirt material possesses a high compression ratio, excellent resilience, self-expanding properties, and adaptive sealing. It demonstrates adaptive deformation during valve crimping, without enlarging the profile of the delivery system. Upon deployment, it actively fills the gaps around the valve perimeter, achieving remarkable anti-PVL performance. About Venus Medtech Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment. For more information, please visit *Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content. *Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned. *VENUSMEDTECH, the stylized QI logo, Venus-Vitae, Venus-Endura etc. are trademarks of Venus Medtech (Hangzhou) Inc. *Venus-Vitae is currently restricted to research only in the EU, North America, and China. SOURCE Venus Medtech (Hangzhou) Inc.

CAMPBELL, Calif.--(BUSINESS WIRE)-- Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced its acceptance into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). Only devices granted Breakthrough Device designation by the FDA may apply to enroll in the TAP Pilot Program. This voluntary program is designed to help ensure U.S. patients have access to high-quality, safe, effective, and innovative medical devices by promoting early, frequent, and strategic communications between the FDA and medical device sponsors. Simpson Intervention’s Acolyte Catheter System was recently designated as a Breakthrough Device on March 4, 2024. The Acolyte Catheter System is a cutting-edge technology, intended to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs), with persistent symptoms, following medical therapy. By providing real-time visualization of coronary CTOs, the Acolyte Catheter System allows for precise guidewire placement and subsequent revascularization, improving patient outcomes and enhancing the standard of care. "Simpson Interventions is honored to be accepted into the FDA's TAP Pilot Program for our Acolyte Catheter System," said Dr. John B. Simpson, Ph.D., M.D., founder and CEO of Simpson Interventions. "This acknowledgment underscores the innovative nature of the device and its potential to address an unmet medical need in the field of interventional cardiology. We look forward to working closely with the FDA to advance the development and commercialization of this breakthrough technology." Simpson Interventions remains steadfast in its mission to bring transformative medical technologies to market, and the acceptance into the TAP Pilot Program marks a significant milestone in this journey. For more information about Simpson Interventions and its innovative medical technologies, please visit . About Simpson Interventions: Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention. For more information:

Designation expedites the review of medical technologies that can improve the lives of patients with life-threatening or debilitating diseases or conditions The Acolyte System is intended to provide interventional cardiologists with a more reliable and predictable tool to facilitate revascularization of chronic total occlusion (CTO) Sixteen to twenty percent of patients with coronary artery disease have CTOs CAMPBELL, Calif.--(BUSINESS WIRE)-- Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced that its groundbreaking Acolyte Image Guided Crossing and Re-Entry Catheter System has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The Acolyte Image Guided Crossing and Re-Entry Catheter System is designed to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions (CTOs) who continue to experience symptoms following medical therapy. This breakthrough device is poised to significantly change the approach to treating coronary CTOs by providing real-time optical coherence tomography (OCT) visualization, enabling precise guidewire placement within the target vessel's true lumen and subsequent revascularization. According to the Journal of the American College of Cardiology: Cardiovascular Interventions, sixteen to twenty percent of patients with coronary artery disease have CTOs1, which occur when a coronary artery is completely blocked by plaque buildup, posing significant challenges for interventional cardiologists who struggle to traverse these lesions with current standard of care options. If a physician fails to cross a CTO, minimally invasive revascularization options such as angioplasty and stent placement cannot be performed. Hence, in the US, many CTO patients are instead sent for bypass surgery. The Acolyte Image Guided Crossing and Re-Entry Catheter System aims to overcome these challenges by providing clinicians with this breakthrough device that has enhanced visualization and navigation capabilities, ultimately improving CTO crossing, procedural success rates, and patient outcomes. "We are thrilled to receive FDA's Breakthrough Device Designation for our Acolyte Image Guided Crossing and Re-Entry Catheter System," said Dr. John B. Simpson, PhD, MD, Founder and CEO of Simpson Interventions. "This designation recognizes the transformative potential of our technology in addressing a critical unmet need in the treatment of patients with coronary chronic total occlusions. We are committed to advancing the field of interventional cardiology and improving patient outcomes through innovation." The FDA's Breakthrough Device Designation is granted to medical devices that offer potential advantages over existing technologies for the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation expedites the development, assessment, and review process, enabling patients to gain access to innovative medical technologies more quickly. Simpson Interventions is committed to collaborating closely with the FDA and other stakeholders to advance the development and regulatory review of the Acolyte Image Guided Crossing and Re-Entry Catheter System. The company looks forward to bringing this revolutionary technology to clinicians, and patients in need. For more information about Simpson Interventions and its innovative medical technologies, please visit . About Simpson Interventions: Simpson Interventions is a leading medical technology company committed to addressing unmet clinical needs in cardiovascular diseases through technological innovations in visual-guidance, enhanced intelligence, and electromechanical automation for minimally invasive percutaneous intervention. For more information: ____________________ 1