CorFlow Therapeutics AG (CorFlow) has claimed that it has been granted by the US Food and Drug Administration (FDA) 'Breakthrough Device Designation' with a broad indication for use statement under its voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
"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," said the firm in a statement.
The Breakthrough Devices Program provides patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health, according to the FDA website.
When contacted by IB Times Singaporefor official link and other details, the company said the medical device side of the FDA (CDRH) does not have a public list of granted breakthrough devices. "We received the FDA approval letter on October 21st but the letter contains confidential information which we can't share with you," said Jon H. Hoem, CorFlow's CEO & Co-Founder in an email reply.
Hoem said the company aimed to develop a technology that fits the workflow for acute heart attack patients and provided a diagnostic tool as well as a therapeutic platform for the coronary microcirculation. The CEO said the company was on an accelerated track to bring the CoFITM System to the US market and looked forward to cooperating with the FDA to ensure the critical technology was available to the patients in need.
According to the company, even if current stent technologies prove to be crucial to saving patients from death and complications after a heart attack, these technologies do not address the unmet medical need for improved coronary microcirculation. The company intended to assess the dynamic microvascular resistance and treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.
This FDA designation is a process aimed at fast-forwarding clinical development and regulatory review of the CoFI System. CorFlow currently enrolls patients into the ongoing European CoFI System's "MOCA I" clinical trial -- a safety and feasibility trial in 40 acute heart attack patients and will expedite US submissions for clinical trials as a result of the Breakthrough Designation.