Pulse Medical's Μfr® System Granted Fda Breakthrough Device Clearance
Pulse Medical Technology, Inc. is a Shanghai-based company that was founded in 2015. Their primary focus is on developing innovative technology for the diagnosis and treatment of polyarteritis nodosa (PAN), a vascular disease. Their latest product, the fourth-generation μFR® System, has recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The μFR® System is a non-invasive physiologic assessment tool that calculates Fractional Flow Reserve (FFR) using multiple imaging data. Unlike traditional methods, which rely on pressure wires or hyperemic agents, the μFR® System offers a more affordable and wider range of indications. It can be utilized throughout the percutaneous coronary intervention (PCI) procedure, including pre-PCI assessment, intraoperative strategy optimization, and post-PCI outcome evaluation.
The Breakthrough Device Designation from the FDA is granted to products that demonstrate the potential to significantly improve the treatment or diagnosis of life-threatening or irreversibly debilitating conditions. This designation allows for an expedited review process, which accelerates Pulse Medical's path to commercialization.
Bing Liu, the President of Pulse Medical, expressed satisfaction with the FDA's recognition of the μFR® System as a breakthrough device. Liu emphasized the global impact of cardiovascular disease and the potential of the μFR® System to provide doctors with valuable insights for effective and accurate treatment, benefiting a larger number of patients.
The efficacy of the μFR® System is supported by robust clinical evidence. The FAVOR III China study, a representative clinical trial, demonstrated a 35% reduction in the risk of major adverse cardiovascular events (MACE) after a one-year follow-up when using the μFR® System. The μFR®-guided patient group also achieved improved prognostic outcomes. These findings will soon be published in the renowned medical journal LANCET.
Looking ahead, Pulse Medical remains committed to advancing the field of pan-vascular intervention through the development of precise and intelligent technologies. Their aim is to usher in a new era of vascular intervention that enhances patient outcomes in the treatment of vascular diseases.