SynFlow®/XinLiu® 3.0 Listed in Pudong New Area’s Innovative Medical Products Directory Following NMPA Approval

ForQaly's Independently Developed SynFlow^®/ Flow^®3.0 Following its approval for market launch by the National Medical Products Administration (NMPA) on June 18, this innovative product has achieved another significant milestone—its official inclusion in the “Pudong New Area Recommended Catalog of Innovative Drugs and Medical Devices” (2026, Second Batch)!

This not only signifies a high recognition of ForQaly’s innovative strength and the clinical value of its products, but also means that this system will receive priority support for clinical application in Pudong New Area, accelerating its availability to patients.

According to the joint public notice issued by the Pudong New Area Science and Technology and Economic Commission, Health Commission, and Market Supervision Administration, this recommended catalog aims to implement the “Implementation Opinions of Pudong New Area on Strengthening Industry-Medical Integration to Promote High-Quality Development of the Biopharmaceutical Industry,” with a focus on supporting the clinical application of innovative drug and medical device products. For products included in the catalog, district-affiliated medical institutions will ensure “full allocation where applicable, rapid hospital admission, and priority use.”

SynFlow^®/ Flow^®3.0 is a percutaneous transvalvular ventricular assist device (pVAD) composed of two core components: the "interventional left ventricular assist device" and the "interventional left ventricular assist catheter pump kit." These two components work synergistically and are indispensable to each other:

Interventional Left Ventricular Assist Device: Responsible for extracorporeal drive and precise control, serving as the "power core" of the system;

Interventional Left Ventricular Assist Catheter Pump Kit: Responsible for pumping blood from the left ventricle to the aorta, it serves as the "execution terminal" of the system.

Used in combination, the system is specifically designed to provide intraoperative support for high-risk PCI patients with severe coronary artery disease, reduced left ventricular ejection fraction, and hemodynamic instability. Simply put, this system acts as a “temporary booster” for cardiac procedures, entering the left ventricle via femoral arterial access to provide robust support for the patient’s fragile hemodynamics, thereby enabling physicians to perform complex interventional procedures more safely and confidently.

Previously, the product entered the National Special Review Procedure for Innovative Medical Devices in January 2023, becoming the first percutaneous interventional ventricular assist pump product in China to enter this “green channel.”

Since its establishment in 2015, ForQaly has remained dedicated to the development of minimally invasive circulatory support devices. Under the brand name “ForQaly,” the company’s founding mission is to “enhance the quality of human life through high-quality, accessible solutions.”

This SynFlow^®/ Flow^®3.0 Inclusion in the Recommended Catalog of Innovative Drugs and Medical Devices of Pudong New Area marks another significant milestone in the company’s development journey. Moving forward, ForQaly will continue to deepen its commitment to technological innovation, accelerate the widespread clinical adoption of its products, and enable more patients with cardiovascular diseases to benefit from the life support and safety assurances provided by high-end domestically produced medical devices.