MCRA, LLC, a leading medical device advisory firm and Clinical Research Organization (CRO) that integrates regulatory, clinical research, reimbursement, compliance and quality assurance, is pleased to announce its role in the successful granting of a Breakthrough Device Designation for the CorFlow Therapeutics AG Controlled Flow Infusion (CoFITM) System by the U.S. Food and Drug Administration (FDA). The CoFITM System is intended to benefit patients who suffer from microvascular obstruction (MVO) following primary percutaneous coronary intervention (PCI). This designation enables CorFlow to accelerate the process of bringing the CoFITM System to patients in the US.
FDA developed the Breakthrough Designation Program to provide an expedited pathway for novel medical devices that have the potential to provide a treatment option to those suffering from a debilitating or life-threatening condition. Breakthrough Designation provides for increased interaction and timely communication between FDA and device manufacturers during product development and throughout the review process. In addition, the Centers for Medicare and Medicaid Services (CMS) has created an alternative new technology add-on payment pathway for devices that have been granted a breakthrough device designation.
CorFlow retained MCRA in July of 2019 to assist with their US Regulatory Strategy. Jon H. Hoem, CorFlow's CEO and Co-Founder, commented: "Even after receiving a stent, many patients continue to suffer from insufficient perfusion of the heart following a heart attack, resulting in unresolved chest pain and higher risks of heart failure and death. CorFlow has developed a technology that can diagnose and enable treatment of the under-perfused coronary microcirculation. We are pleased to have partnered with MCRA to obtain an accelerated pathway to bring the CoFITM system to the US market.”
Michael John, Vice President of Cardiovascular Regulatory Affairs at MCRA, said, "FDA has clearly recognized the need to streamline the regulatory process for potentially disruptive technologies that address an unmet clinical need. CoFITM can diagnose and potentially treat an underappreciated but prevalent and dangerous clinical scenario for which no viable therapeutic options exist. We were thrilled to assist CorFlow on their Breakthrough Designation Submission for the CoFITM system, and that this novel and differentiated therapy now has an expedited pathway through the regulatory process.”
About MCRA, LLC: Founded in 2004, MCRA is a leading Clinical Research Organization (CRO) and advisory firm. MCRA's value contribution rests within in its industry experience at integrating five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance to provide a dynamic, market leading effort from concept to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include cardiovascular, orthopedics, spine, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics and in vitro diagnostic (IVD) devices.