CorFlow Therapeutics AG (CorFlow), a pioneer in the field of cardiac care with a focus on microvascular diseases, announced that the U.S. Food & Drug Administration (FDA) has approved the company’s technology for Investigational Device Exemption (IDE), enabling the pilot clinical trial to begin in U.S. hospitals. CorFlow now plans to prepare these clinical trial sites for the implementation of CorFlow systems, conduct the necessary training and begin enrolling patients for acute myocardial infarction treatment.
The IDE clinical trial, designated MOCA-II, aims to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl system in identifying the presence or absence of microvascular obstruction (MVO) during a primary percutaneous coronary intervention (PCI) procedure. The primary endpoint compares the diagnostic CoFI reading to a reference standard for cardiac magnetic resonance imaging. The study has been approved to enroll more than 200 patients with ST-segment elevation myocardial infarction (STEMI) at leading research institutions in the United States and Europe.
Following the successful completion of the first-in-human MOCA-I trial in 2024, the MOCA-II study represents the next critical step in making this innovative technology available to interventional cardiologists worldwide for the rapid diagnosis of MVO in patients with myocardial infarction. This, in turn, could lead to new treatment options and care strategies for the large population of MVO patients who currently experience high rates of adverse clinical outcomes. CorFlow technology was developed for the diagnosis of MVO and also to serve as a localized drug delivery system for diagnostic and therapeutic agents, which is currently being investigated as a stand-alone device.
According to the U.S. Centers for Disease Control and Prevention, a person suffers a heart attack every 30 seconds in the United States, with an average of 800,000 cases reported annually in the United States. The incidence and prevalence are similarly high in Europe. More than half of patients with ST-segment elevation myocardial infarction have MVO, and previous research has shown that the presence of MVO is a major contributor to adverse events. There are currently no approved technologies for the diagnosis of MVO during acute coronary intervention, and there are no therapeutic devices specifically approved to treat MVO in the United States or Europe. Heart attacks and associated cardiac pathologies remain a leading cause of death and disability globally.
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Paul Mead, CEO of CorFlow, said: “The long history of advances in interventional cardiology and heart attack treatment, stretching back over 100 years, is one of the great success stories of healthcare progress. However, pioneers and leaders in the field agree that the work is not yet done. The majority of STEMI survivors now have MVO, and current outcomes for these patients have been surprisingly poor. Our goal is to highlight this issue and show that action is possible. This milestone brings us one step closer to the promise of improving care for these people, where we are convinced that improvements can be made.”
MOCA-II is led by world-renowned experts in heart attack care, Dr. Timothy Henry of The Christ Hospital in Cincinnati, Ohio (United States) and Professor Marco Valgimigli of Cardiocentro Ticino Institute, Lugano (Switzerland), who together have published more than 1,000 peer-reviewed manuscripts in cardiovascular research.
Dr. Tim Henry said, “As an interventional cardiologist who has spent decades treating and researching patients with STEMI, I am thrilled to begin this pivotal study with technology that can so significantly impact the outcomes of our patients. I am convinced that reliably identifying who has MVO at the point of care during a primary percutaneous coronary intervention (PCI) procedure can immediately impact the way we treat our patients.” Professor Valgimigli added, “Having played a significant role in the first-in-human trial of MOCA-I, I am thrilled to see the second-generation technology now available for the pivotal trial and look forward to furthering the scientific understanding of MVO in real time. While the medical community has mixed opinions on how to treat these patients, it is undeniable that proper diagnosis is the first step. I am confident that the approval of CorFlow technology for daily use by our interventional cardiology colleagues will contribute to advancing the field.”
Source: Businesswire