SUZHOU, China, Nov. 29, 2023 /PRNewswire/ -- Earlier this month, magAssist Co.,Ltd. ("magAssist" and "the Company"), a leading medical developer of extracorporeal life support devices in China, attended the 29th annual meeting of the International Society for Mechanical Circulatory Support (ISMCS) as a corporate member. The conference, held in Dallas, Texas, from October 30 to November 1, 2023, served as a crucial platform for scientific exchange in the field of mechanical circulatory support, and saw magAssist introduce its latest innovation – NyokAssist – an interventional ventricular assist device which has completed its first-in-human (FIM) procedure in China this August.
Held once a year, the ISMCS gathers global experts and scholars in the circulatory mechanical industry under the same roof, fostering collaboration to explore research, development, clinical applications, and social acceptance of rotary blood pumps and related mechanical circulatory support systems. It aims to help develop technologies, applications, and clinical procedures for rotary blood pumps and associated systems, enhancing the life quality for recipients and ensuring cost-effective access to emerging therapies. ISMCS is also a supporter of the world's first competition dedicated to artificial heart design, Heart Hackathon, which is sponsored by MedTech industry leaders including magAssist that help catalyze cardiovascular innovation.
During the meeting, magAssist showcased how the company's latest technological breakthroughs bridge the clinical gaps and address the unmet medical needs of patients suffering from severe heart diseases. Dr. Thomas George Logan, magAssist's Chief Engineer and Chief Scientist, who was also one of the juries of the Heart Hackathon, has provided updates on the groundbreaking innovations of magAssist's product NyokAssist.
NyokAssist: The New Generation of Interventional VAD
Earlier in August, NyokAssist completed its first-in-man procedure. The FIM use of NyokAssist which supports high-risk percutaneous coronary interventions (PCI) was completed by Dr. Junbo Ge and his colleagues from Zhongshan Hospital in Shanghai, with the procedure performed on a man in his 40s with coronary artery disease, heart failure, type II diabetes, and post-PCI. Given the patient's high surgical risk, Dr. Ge's team decided to perform PCI with NyokAssist, which delivered a safe and effective result throughout the procedure, providing an average flow of more than 3L/min and maintaining stable blood pressure. The patient was discharged two days later. (Note: The patient's information has been authorized by the patient's consent and has been anonymized to ensure the protection of individual confidentiality.)
Marking a new milestone for magAssist, NyokAssist's successful FIM procedure follows the announcement that the device has received U.S. Food and Drug Administration (FDA) Breakthrough Device designation, a recognition that underscores the pioneering features of NyokAssist and reconfirms magAssist's position as a pioneer in the landscape of advanced medical devices.
MoyoAssist：A Lifesaving Solution for Heart Failure Patients
Also participated as one of the corporate delegates, IFan Yen, the Vice President of magAssist R&D Department, addressed the unmet medical needs for patients suffering from severe heart diseases and provided latest updates on MoyoAssist Extra-VAD.
"Cardiovascular diseases claim over 17.9 million lives annually, representing over 30% of global deaths, exceeding 40% in China, according to the World Health Organization. In response to this significant health challenge, we developed our first high-tech Class III product, MoyoAssist Extracorporeal Ventricular Assist Device, which offers reliable, lifesaving alternatives for heart failure patients with better clinical outcomes," said IFan.
Equipped with a disposable pump head, full maglev motor, and a portable console, MoyoAssist can offer up to 30 days of support time, designed for patients with AMI-CS, PCCS, BTT, and Bi-ventricular heart failure. The device harnesses advanced computational fluid dynamics and full maglev technology to achieve optimal hemocompatibility, significantly reducing the risk of device-related thrombosis, coupled with an advanced flow path design that provides effective perfusion of all the organs for MODS patients.
"It is an honor for magAssist to be a corporate member of ISMCS and the industry partner of Heart Hackathon that fuel transformative changes in the field. As a MedTech innovator that strives to empower healthcare professionals to offer better treatments to patients with state-of-the-art technology and services, our mission aligns with the aims of the two events through which we aspire to further ignite inspiration for the next-gen lifesaving solutions," said IFan.
"At the core of magAssist's mission and industry standing lies a deep commitment rooted in cardiac care. Since its establishment, magAssist has remained dedicated to advancing medical technology and has applied for over a hundred patents, propelling the development of medical technology through innovation, research, and patient-centric solutions. In pursuit of creating a multi-organ support platform that allows global patients to access cost-effective and high-quality treatments, we continue to bring more value for healthcare professionals and the medical device industry as a whole," IFan added.
To learn more about magAssist product updates , please visit:
magAssist's NyokAssist™️ granted Designation by the FDA as a Breakthrough Device (prnewswire.com)
About magAssist
magAssist is one of the leading medical device companies in the healthcare industry, focused on developing circulatory support devices for acute/severe cardiac and pulmonary failure. Our products include extracorporeal ventricular assist device (extra-VAD), interventional ventricular assist device, extracorporeal membrane oxygenation systems (ECMO), and organ care systems. Our first product MoyoAssist Extra-VAD has completed clinical trials in China. NyokAssist Interventional VAD, the innovative product, has been designated as a breakthrough device by the FDA. Moving forward, magAssist is dedicated to providing valuable technology for patients and clinicians worldwide.
Disclaimer:
magAssist products have not yet received approvals from either the U.S. FDA or China NMPA at this stage. The content is intended solely for informational purposes, with a focus on providing information including industry and academic exchange. It is not intended for advertising and should not be considered as an advertisement, either explicitly or implicitly. Nor shall it be considered for any purpose of offering to sale or sale. For precise information, please seek guidance from a healthcare professional.
