CorFlow’s Controlled Flow Infusion System Granted FDA Breakthrough Device Designation
October 23, 2019—CorFlow Therapeutics AG announced that the company has been granted FDA Breakthrough Device designation for its CorFlow controlled flow infusion (CoFI) system with an indication for diagnostic assessment of the coronary microcirculation immediately after percutaneous coronary interventions (stenting) and as a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.
CorFlow advised that it will continue to cooperate with the FDA as the CoFI keeps on an accelerated track for approval. The company is conducting the ongoing European first-in-human MOCA I clinical trial and will expedite the United States submissions for clinical trials in light of the Breakthrough Device designation. The MOCA I is a safety and feasibility trial that is enrolling 40 patients with acute ST-elevation myocardial infarction.
The company noted that FDA Breakthrough Device designation is granted to medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The objective of the FDA Breakthrough Device program is to provide patients and health care providers with timely access to these novel medical devices by speeding their development, assessment, and review, while preserving the standards for medical device approvals. Additionally, the Centers for Medicare & Medicaid Services has instituted a new rule that will increase payments for medical devices designated by the FDA as breakthrough devices.