FDA Grants Breakthrough Device Designation to Pulse Medical’s μFR System

Pulse Medical Technology Inc.’s (Pulse Medical) fourth-generation μFR system has won U.S. Food and Drug Administration (FDA) Breakthrough Device designation. 
 
The μFR is an angio-based physiological assessment tool without a pressure wire or hyperemic agents that 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.
 
“We are delighted that μFR has been designated an FDA breakthrough device,” Pulse MEdical President Bing LIU said. “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 has various robust clinical evidence that provides its outcome benefits. The representative FAVOR III China clinical trial shows that μFR could bring a 35% MACE risk reduction, according to a one-year follow-up. 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.

Founded in 2015, Shanghai, China-based Pulse Medical develops technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. Pulse Medical invented the key algorithm of μFR, the fast computation methodology of fractional flow reserve (FFR) from multiple imaging data. The computed tomography based FFR (CT-μFR), angiography-based FFR solution (Quantitative Flow Ratio in first generation, μFR in second generation) and intracoronary IVUS or OCT-based FFR (UFR, OFR) have been commercialized.