CorFlow Therapeutics has announced that the company has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Controlled Flow Infusion (CoFI) System. It is indicated for the diagnostic assessment of the coronary microcirculation immediately after percutaneous coronary interventions (PCI) and as a platform for controlled infusion of therapeutic agents into the microcirculation, with or without vessel occlusion.
Commenting in a press release from the company, CEO and co-founder Jon H Hoem says: “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 says it is pleased to be on an accelerated track to bring the CoFI System to the US market and looks forward to continuing the cooperation with the FDA to ensure that this critical technology is available to the patients in need. The statement says that the company 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 heart attack patients.
The FDA Breakthrough Designation Program was launched in December 2018 and 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 programme is to provide patients and healthcare providers timely access to novel medical devices by speeding their development, assessment and review, while preserving the standards for medical device approvals. The Centers for Medicare & Medicaid Services (CMS) has also instituted a new rule that will increase payments for medical devices designated by the FDA as breakthrough devices.