Pulse Medical Receives FDA Breakthrough Device Designation for μFR® System

Shanghai-based Pulse Medical has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its 4th generation μFR® system.

Founded in 2015, Pulse Medical is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. Pulse Medical has been pioneering and invented the key algorithm of μFR®, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.

The μFR is an angio-based physiological assessment tool without a pressure wire or hyperemic agents. It has a wider range of indications and is more affordable. μFR® can be used throughout the entire PCI procedure, including precise physiology assessment at Pre-PCI, strategy optimization during the operation, outcome and microcirculatory function assessment at Post-PCI.

A device must demonstrate that it has the potential to offer for more efficient treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions to be eligible for the Breakthrough Device Designation. The classification enables a coordinated and expedited review process with FDA, accelerating the commercialization of Pulse Medical.

“We are delighted that μFR® has been designated an FDA breakthrough device. “said Bing LIU, the president of Pulse Medical. “Cardiovascular diseases are the leading cause of death globally; an estimated 17.9 million people died from that in 2019. μFR® as a physiological assessment tool could provide more insights to physicians and help more patients have an effective and precise treatment.”

The μFR® also have various robust clinical evidence that provides its outcome benefits. The representative FAVOR III China clinical trial shows that according to a 1-year follow-up, μFR® could bring a 35% MACE risk reduction. The patient group guided by μFR® could also gain a better prognostic result, and the result is published in LANCET.

In the future, Pulse Medical will continue to dedicate itself to the pan-vascular field, fostering a new era of precise and intelligent vascular intervention.