Pulse Medical receives FDA Breakthrough Device Designation for its μFR® system
SHANGHAI, May 26, 2023 /PRNewswire/ -- Pulse Medical Technology, Inc. (Pulse Medical) 4th generation μFR® system has received an FDA Breakthrough Device designation.
Pulse Medical, founded in 2015, located in Shanghai, China, 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.
For more information about Pulse Medical, Please visit http://en.pulse-imaging.com/
CONTACT: Yiran Duan, Phone: +86-13641283502
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