Pulse Medical Technology, Inc., a Shanghai-based company founded in 2015, has announced that its fourth-generation μFR® system has been granted FDA Breakthrough Device designation. The company focuses on developing innovative technology for precise diagnosis and optimal treatment of patients with pan-vascular disease. The μFR® system, which utilizes a fast computation methodology for fractional flow reserve (FFR) assessment from multiple imaging data, is an angio-based physiological assessment tool that eliminates the need for pressure wires or hyperemic agents.
The Breakthrough Device designation is given to devices that show potential for more efficient treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This designation enables an expedited review process with the FDA, facilitating the commercialization of Pulse Medical's μFR® system.
Bing LIU, President of Pulse Medical, expressed excitement about the FDA breakthrough designation and highlighted the global impact of cardiovascular diseases. The μFR® system, as a physiological assessment tool, aims to provide physicians with more insights and help improve the effectiveness and precision of treatment for patients.
Pulse Medical's μFR® system has demonstrated robust clinical evidence supporting its benefits. The FAVOR III China clinical trial, a representative study, revealed a 35% reduction in major adverse cardiovascular events (MACE) risk with μFR® guidance at a one-year follow-up. The results of this trial were published in LANCET, further validating the effectiveness of the system.
Pulse Medical remains dedicated to advancing the field of pan-vascular interventions and aims to foster a new era of precise and intelligent vascular intervention.