SynFlow® 3.0 Selected for Pudong New Area Innovative Drug and Medical Device Recommendation Catalog

SHANGHAI —

When a patient with severe coronary artery disease and unstable hemodynamics needs a complex heart procedure, surgeons at Pudong New Area's hospitals now have a new tool at their disposal: the SynFlow® 3.0, a homegrown percutaneous ventricular assist device — or pVAD — that acts as a temporary booster for the heart during high-risk interventions.

The device, developed by ForQaly Medical (Shanghai) Co., Ltd., has just been selected for the Pudong New Area Innovative Drug and Medical Device Product Recommendation Catalog (2026, Second Batch), according to a public notice jointly issued by the district's Science and Technology and Economic Committee, Health Commission, and Market Supervision Administration.

The listing is more than a badge of honor. Under the policy, district-level medical institutions are required to equip, fast-track hospital admission, and prioritize use of the products on the list — a move that could accelerate the device's path from regulatory approval to the operating table.

A 'Temporary Booster' for the Heart

The SynFlow® 3.0 is a percutaneous transvalvular ventricular assist device (pVAD) consisting of two core components that work in tandem. The interventional left ventricular assist device serves as the system's power core, providing external drive and precise control. The interventional left ventricular assist catheter pump kit acts as the execution terminal, pumping blood from the left ventricle into the aorta.

Inserted through the femoral artery, the system is designed for patients with severe coronary artery disease, reduced left ventricular ejection fraction, and hemodynamic instability who are undergoing high-risk percutaneous coronary intervention, or PCI. It provides circulatory support during the procedure, allowing surgeons to operate with greater confidence on fragile patients.

Breaking the Foreign Monopoly

ForQaly's journey to this point has been a decade in the making. Founded in 2015, the company took its name from QALY — Quality Adjusted Life Year — signaling a mission to improve human life quality through high-quality, affordable solutions.

In January 2023, the SynFlow® 3.0 became the first pVAD product to enter China's National Innovative Medical Device Special Review Procedure — the regulatory "green channel" — where it successfully cleared core technical barriers including long-distance flexible transmission and an innovative motor separation structure.

On June 18, the device received market approval from the National Medical Products Administration (NMPA), becoming the first domestically developed interventional ventricular assist pump to break foreign technology monopoly and fill a gap in China's pVAD landscape.

From Approval to Bedside

The latest inclusion in Pudong's recommendation catalog marks another milestone. The policy, aimed at implementing the district's guidelines on strengthening industry-medical integration for high-quality biomedical development, gives listed products preferential clinical application support.

For ForQaly, the next challenge is translating regulatory wins and policy backing into widespread clinical adoption — turning a homegrown breakthrough into real-world cardiac support for patients who need it most.