HeartCon's NyokAssist® Receives FDA Breakthrough Device Designation as World’s Smallest Percutaneous Ventricular Assist Device

Recently,HeartPump Medical Interventional Artificial Heart NyokAssist^®Received the U.S. Food and Drug Administration (FDA) “Breakthrough Device” designation, becoming the first domestically developed interventional artificial heart to receive this recognition.This not only signifies international recognition of the product’s innovation and clinical value but will also accelerate its regulatory approval process in the United States.

“Breakthrough Device” is a “fast-track” pathway launched by the U.S. Food and Drug Administration (FDA) in 2015 to accelerate the development and review of innovative medical devices. The United States, home to the largest number of top-tier medical technology companies globally, has long been the leader in medical technology innovation.The FDA’s “Breakthrough Device” designation represents the highest level of technological innovation globally.

Among the devices previously granted “Breakthrough Device” designation are numerous cutting-edge products from global leading medical technology companies, including Johnson & Johnson, Abbott, Medtronic, and Boston Scientific. To receive the FDA’s “Breakthrough Device” designation, a device must meet the following key criteria:“is an original technology on a global scale, and can more effectively treat or diagnose life-threatening or irreversibly debilitating human diseases or conditions, with no approved protocols or alternatives available, or it offers significant advantages over existing approved or alternative solutions. The availability of the device aligns with the best interests of patients.”The FDA will provide services such as device development support, priority review of clinical trial protocols, dedicated review team assistance, and guidance on commercialization decisions for products granted “Breakthrough Device” designation.

Interventional Artificial Hearts as a Protective Measure for High-Risk Percutaneous Coronary Intervention (HRPCI): A Strong Correlation Between Device Profile and Vascular Complications, Bleeding, Transfusion Requirements, and Major Adverse Cardiovascular Events^[1]. Currently, the only product in clinical use worldwide is Johnson & Johnson’s Impella CP device, which has an insertion size of 14 Fr and is prone to causing vascular complications, making it unsuitable for patients with vascular stenosis. To address this pain point, Johnson & Johnson’s latest-generation product focuses on reducing the insertion size as its direction for iteration. Thus, it can be seen thatSmaller Interventional Sizes Are the Core Focus for Leading Global Medical Device Companies Seeking Technological Breakthroughs。

Xinqing Medical NyokAssist^®The interventional artificial heart adopts a foldable impeller design, featuring the smallest delivery profile among similar products worldwide (9Fr, 3mm).^[2], which can minimize bleeding to the greatest extent, reduce the incidence of perioperative and postoperative vascular complications, and meet the needs of patients with small-diameter vessels or arterial stenosis. Once inside the body, the impeller can rapidly expand to an operating size exceeding 21Fr, thereby enabling higher flow rates while operating at a lower rotational speed, which reduces hemolysis caused by high-speed rotation of the impeller. In addition, NyokAssist^®The external motor design effectively prevents hemolysis caused by heat generation when the motor is placed inside the body. Given the large volume of HRPCC procedures performed in China, utilizing the high-value motor as a reusable component can significantly reduce costs, offering substantial health economic value.

NyokAssist^®The interventional artificial heart, developed by HeartEngine Medical in collaboration with the team of Academician Ge Junbo from Zhongshan Hospital affiliated to Fudan University in response to the national call, has achieved integrated innovation through medical-engineering cross-disciplinary collaboration. It has currently completed development processes such as type testing and animal trials, and is poised to commence clinical trials.

9Fr Interventional Size, the Smallest in the Industry

Rapid expansion and release upon entering the body

 Folded impeller design enables higher flow rates at lower rotational speeds.

 The external motor design prevents intracorporeal heat generation that could cause hemolysis and allows for reuse, thereby reducing costs.

Last month, MedHeart’s fully magnetically levitated extracorporeal artificial heart and its next-generation integrated extracorporeal membrane oxygenation (ECMO) system were granted designation as National Innovative Medical Devices, thereby entering the “green channel” for market approval. With the interventional artificial heart NyokAssist® poised to enter clinical trials, MedHeart’s multi-organ life support platform is now entering a phase of comprehensive acceleration.

References:

[1] Sidawy, A. N., & Perler, B. A. (2022). Rutherford’s Vascular Surgery and Endovascular Therapy (10th ed., Vols. 2-Volume Set).

[2] Bhuiyan, R., Bimal, T., Fishbein, J., Bandotra, P., Selim , S., Ong, L., & Gruberg, L. (2023, May 8). Percutaneous Coronary Intervention with Impella Support with and without Intra-Aortic Balloon in Cardiogenic Shock Patients. ScienceDiret.