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.

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.

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.

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.”