FDA Grants CorFlow Breakthrough Designationadmin
The US FDA Grants CorFlow Breakthrough Designation
Baar, Switzerland, October 23rd 2019
CorFlow Therapeutics AG (“CorFlow”) today announced that the company has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA) with a broad indication for use statement.
The CorFlow Controlled Flow Infusion (CoFITM) System is included in the Breakthrough Designation Program with the following 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.”
Jon H. Hoem, CorFlow’s CEO and co-Founder, commented: “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 is pleased to be on an accelerated track to bring the CoFITM System 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.
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, these technologies don’t address the unmet medical need of improved coronary microcirculation. Reduced coronary microcirculation has proven to be an independent marker for complications after a heart attack such as heart failure and death.
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 program is to provide patients and healthcare providers timely access to these novel medical devices by speeding their development, assessment and review, while preserving the standards for medical device approvals. CMS has also instituted a new rule that will increase payments for medical devices designated by the FDA as breakthrough devices.
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 heart attack patients.
About the FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program guidance document was issued on December 18th 2018. The program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo request”). Even if the program does not guarantee FDA clearance, it provides a framework for more effective collaboration between companies with breakthrough technologies and the FDA. Specifically the program provides:
- Breakthrough Device sprint discussions with defined topics and interaction schedule
- Clear documentation of interactions and conclusions
- Defined data development plan (DDP)
- Agreement on clinical protocol designs for regulatory and reimbursement purposes
- Regular status updates between the FDA and the company
These improvements are important to provide more transparent information exchange between the FDA and the companies especially for technologies with new approaches to treat current unmet medical needs.