MicroPort® Kewei Membrane Oxygenator Gains Access to China’s Special Approval Procedure for Innovative Medical Devices

Dongguan, China, 11 November 2021 – The Vitasprings® Spiral Diversion Integrated Membrane Oxygenator (Vitasprings®), developed by Dongguan Kewei Medical Instrument Co., Ltd. (MicroPort® Kewei), a subsidiary of MicroPort Scientific Corporation (MicroPort®), was given access by the National Medical Products Administration (NMPA) of China to enter the special approval procedure for innovative medical devices, also known as the ‘Green Path’. As of the press release date, total of 25 products by MicroPort® or affiliated companies have entered the ‘Green Path’.

Vitasprings® is the first highly integrated product developed in China that imitates the function of the lungs in cardiopulmonary bypass and adopts an innovative hemodynamic structure featuring a spiral flow guide and secondary diversion combined with a vortex exhaust design, which can reduce damage to blood cells. Bringing together the high performance of three modules — temperature variation, gas exchange, and microembolism filtration — Vitasprings® provides excellent oxygenation performance and venting ability, allowing for better gas exchange and reducing the risk of potential complications for patients.

A membrane oxygenator, also called an ‘artificial lung’, is a single-use artificial device for blood gas exchange, which can perform blood oxygenation and remove carbon dioxide in place of the lungs with the advantages of high gas exchange efficiency and minimal blood damage. China has 330 million cardiovascular patients nationwide and over 200,000 cardiac surgeries are performed annually. Membrane oxygenators are the most critical core consumable component of the extracorporeal circulation system in cardiac surgeries. Extracorporeal Membrane Oxygenation (ECMO) systems, which rely on membrane oxygenators as a core component, played an important role in treating critical patients during the Covid-19 outbreak.

Mr. Zhiguang Cheng, President of MicroPort Surgical (Shanghai) Co., Ltd., said, “As one of the first companies in China to focus on oxygenator research, MicroPort® Kewei always strives to develop quality products with independent intellectual property rights by adopting the design concept of boundless bionics. Vitasprings® has passed strict clinical tests on safety and efficacy, and all key indicators have demonstrated its world-leading quality, demonstrating our ability to design complex integrated structures and conduct hydrodynamic analysis for membrane oxygenators. In the future, through continuous technological innovation, MicroPort® Kewei will continue to improve the overall level of extracorporeal life support products, including oxygenators and premium supporting cannulae, to provide patients with better and more affordable extracorporeal life support solutions.”

MicroPort® started a prospective, multicenter, randomized, single-arm, active-controlled clinical trial for Vitasprings® in August 2020 and has completed subject enrollment by the end of January 2021. The trial was led by Beijing Anzhen Hospital affiliated to Capital Medical University, with participation from the Wuhan Asia Heart Hospital, West China Hospital of Sichuan University, and Tianjin Chest Hospital. The performance of Vitasprings® in the trial was found to be comparable to that of leading international products. Its advantages of low priming volume, low transmembrane pressure, and ease of operation were fully recognized by clinical experts. Vitasprings® is also the first membrane oxygenator in China that is successfully tested under the requirements of the latest Good Clinical Practice (GCP) for Medical Device Trials, which has proved its safety and efficacy in clinical applications.

Data Source:

1. Chinese Cardiovascular Health and Disease Report 2020