Pulse Medical μFR system gets FDA breakthrough status for pan-vascular diagnosis


Pulse Medical Technology has announced that its fourth-generation μFR system has received breakthrough device designation from the US Food and Drug Administration (FDA) for pan-vascular diagnosis.

The Shanghai-based company founded in 2015, is dedicated to developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. It is said to have pioneered and invented the key algorithm of μFR, a fast computation methodology of fractional flow reserve (FFR) from multiple imaging data.

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The μFR system is an angio-based physiological assessment tool that does not require a pressure wire or hyperemic agents. It offers a wider range of indications and is more affordable compared to traditional methods.

The device can be utilized throughout the entire percutaneous coronary intervention (PCI) procedure, providing precise physiology assessment pre-PCI, optimizing strategies during the operation, and assessing outcomes and microcirculatory function post-PCI.

The breakthrough device designation from the FDA is granted to devices that have the potential to offer more efficient treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation facilitates a coordinated and expedited review process, accelerating the commercialization of Pulse Medical’s μFR system.

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The μFR system is supported by robust clinical evidence, including the representative FAVOR III China clinical trial. The trial demonstrated a 35% reduction in major adverse cardiac events (MACE) risk at a 1-year follow-up for patients guided by μFR. The positive prognostic results of μFR have been published in LANCET, further validating its outcome benefits.

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Bing LIU — Pulse Medical president said: “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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