CorFlow Therapeutics has been granted Breakthrough Device designation from the FDA for its CorFlow Controlled Flow Infusion (CoFITM) system. According to a press release, the device is included in the Breakthrough Designation programme with the indication for use statement: “The CoFITM System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.”
The press release reports that CorFlow is pleased to be on an accelerated track to bring the CoFITM sSystem to the US market and looks forward to continue the cooperation with the FDA to ensure that this critical technology is available to the patients in need. It adds that, based on recent market research in the US and Europe, CorFlow estimates that more than 170,000 patients per year need new technologies to improve the coronary microcirculation after ordinary stent implantation. Even if current stent technologies have proven to be crucial to save patients from death and complications after a heart attack, the press release claims, these technologies do not address the unmet medical need of improved coronary microcirculation.
Jon H Hoem, CorFlow’s CEO and co-Founder, comments: “The FDA Breakthrough Designation approval is an important validation of the vision the CorFlow Founders had when founding the company in June 2016—to develop a technology which fits the workflow for acute heart attack patients and which provides a diagnostic tool as well as a therapeutic platform for the coronary microcirculation. It also reflects the true spirit of the CorFlow team and how the team achieves demanding milestones which will bring the CorFlow technology to patients in need of improved coronary microcirculation.”
CorFlow continues to enrol patients into the ongoing European First-in-Man MOCA I clinical trial and will expedite the US submissions for clinical trials in light of the Breakthrough Designation. The MOCA I trial is a safety and feasibility trial in 40 acute myocardial infarction patients.