Chinese medical device company Pulse Medical Technology has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its fourth generation μFR system.

The μFR is an angio-based physiological assessment tool that eliminates the need for pressure wire or hyperemic agents and can be used for various indications.

The system can be used during different stages across the entire PCI procedure.

It can be used for physiology assessment before PCI, strategy optimisation during the operation, and microcirculatory function assessment post-PCI.

Pulse Medical president Bing LIU 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.”

Established in 2015, Pulse Medical is dedicated to developing advanced technology for accurate diagnosis and optimal treatment of patients with cardiovascular disease.

The company has created the critical algorithm of μFR, a rapid computation methodology of fractional flow reserve (FFR) from multiple imaging data.

In May last year, Pulse Medical announced that its μFR system improved clinical outcomes and saved costs in FAVOR III China clinical trial, a one-year follow-up.

The study estimated the FFR, an invasive procedure involving pressure-wire manipulation, in 3,830 adult coronary artery disease (CAD) patients.

In the FAVOR III China trial, the μFR system could bring a 35% MACE risk reduction and help the patient group gain better prognostic results, said Pulse Medical.