Pulse Medical receives FDA BDD for its μFR system
Shanghai, China-based Pulse Medical Technology has announced that its 4th generation μFR system has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA).
Pulse Medical focus on the precise diagnosis and optimal treatment of patients with pan-vascular disease, working on its algorithm of μFR, a fast computation methodology of fractional flow reserve (FFR) from multiple imagining data.
The μFR system is an angio-based physiological assessment tool without a pressure wire or hyperemic agents, and has a wide range of indications. It is intended for use throughout the PCI procedure.
The BDD follows clinical evidence from various trials, including the FAVOR III clinical trial which shows that at a 1-year follow-up, the μFR system led to a 35% MACE risk reduction.
Bing Liu, president of Pulse Medical, commented: “We are delighted that μFR has been designated an FDA breakthrough device. 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.”
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