FDA Approves CorFlow’s MOCA-II IDE Pivotal Trial to Advance Breakthrough Heart Attack Technology
CorFlow Therapeutics AG, a Swiss-based medtech innovator specializing in cardiovascular care and microvascular disease, has reached a major milestone in the development of its cutting-edge heart attack treatment technology. The company announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for its pivotal clinical trial, MOCA-II, which will now begin enrolling patients in the United States.
This IDE approval clears the way for CorFlow to initiate its groundbreaking study at leading research hospitals across the U.S. and Europe. The trial seeks to validate the company’s novel CorFlow CoFI (Control Flow Intervention) system—a technology designed to assess microvascular obstruction (MVO) in heart attack patients during a primary percutaneous coronary intervention (PCI), the standard emergency procedure used to treat ST-elevation myocardial infarctions (STEMI).
MOCA-II: A Pivotal Trial Aimed at Transforming Acute Heart Attack Care
The MOCA-II (Microvascular Obstruction Controlled Assessment II) trial is designed to evaluate the diagnostic accuracy of the CorFlow CoFI system in identifying the presence or absence of microvascular obstruction at the time of intervention. MVO is a critical yet frequently undiagnosed condition where, even after reopening the blocked coronary artery, small blood vessels within the heart muscle remain obstructed, limiting oxygen delivery and increasing the risk of complications.
In the MOCA-II study, the CoFI system’s diagnostic results will be compared against cardiac MRI, the current gold standard for assessing microvascular injury—but one that cannot be performed in real time during a heart attack. The trial has been cleared to enroll over 200 STEMI patients at top-tier institutions in both the United States and Europe.
This pivotal study follows the successful completion of MOCA-I, a first-in-human trial conducted in 2024 that demonstrated the feasibility and potential impact of CorFlow’s approach. MOCA-II represents the final clinical step before regulatory review for commercial use.
A Dual-Purpose Platform: Diagnosis and Targeted Drug Delivery
What sets the CorFlow CoFI system apart is its dual functionality. In addition to diagnosing MVO at the time of the primary PCI procedure, the system also has the capability to serve as a localized drug delivery platform. This aspect is currently under separate investigation and could eventually enable interventional cardiologists to not only detect but also treat MVO directly in the catheterization lab.
The implications of this are far-reaching. For the first time, physicians could be empowered with real-time diagnostic feedback and targeted therapeutic options during the most critical moments of heart attack care—potentially changing the clinical trajectory for millions of patients worldwide.
A Major Unmet Need in Cardiology
According to the Centers for Disease Control and Prevention (CDC), one person in the U.S. has a heart attack approximately every 30 seconds, amounting to around 800,000 cases per year. Europe reports similarly high incidence rates. Among patients treated for STEMI heart attacks, research shows that more than 50% exhibit MVO, even after the artery is reopened via PCI.
Despite its prevalence and strong association with adverse outcomes—including heart failure, arrhythmias, and even death—there is currently no approved technology in the U.S. or Europe for diagnosing MVO during acute care. Likewise, no interventional devices have been authorized for treating MVO in real time.
This gap in care presents both a challenge and a tremendous opportunity. Identifying MVO during the initial treatment window could be a game-changing advancement, helping reduce complications and improve long-term outcomes for heart attack survivors.
Leadership Perspective: A Long-Awaited Breakthrough
Paul Mead, CEO of CorFlow Therapeutics, framed the FDA’s IDE approval as a pivotal moment in the evolution of cardiovascular care.
“The long history of interventional cardiology and heart attack care breakthroughs—going back over 100 years—is one of the great success stories of medical progress,” Mead said. “But the pioneers and luminaries of the field all agree that the work is unfinished.”
Mead emphasized that many STEMI survivors today still suffer poor outcomes, largely due to undiagnosed MVO, and that current treatment protocols fail to address this hidden burden.
“The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor,” he added. “We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise of improving care for these people where we know we can do better.”
Global Experts Join Forces to Lead MOCA-II
The MOCA-II trial is being spearheaded by two of the world’s most respected figures in interventional cardiology:
- Dr. Timothy Henry, Director of Interventional Cardiology at The Christ Hospital in Cincinnati, Ohio, and
- Professor Marco Valgimigli, Interventional Cardiologist at the Cardiocentro Ticino Institute in Lugano, Switzerland.
Together, these investigators bring decades of experience and more than 1,000 peer-reviewed publications in cardiovascular research to the trial.
Dr. Henry expressed enthusiasm about the potential of CorFlow’s technology to reshape patient outcomes:
“As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients.”
“I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients.”
Professor Valgimigli echoed that sentiment and emphasized the importance of diagnosis:
“Having played a significant part in the MOCA-I first-in-human trial, I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time.”
“While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.”
What Comes Next
With FDA approval of the IDE application now in hand, CorFlow will begin preparing U.S. trial sites by shipping the CoFI systems, training interventional cardiology teams, and initiating patient enrollment. European sites are also being finalized and will participate in the multinational effort to collect robust, high-quality clinical data.
Pending the results of the MOCA-II trial, CorFlow plans to submit for regulatory approval to market the CoFI system as the first MVO diagnostic platform approved for use during primary PCI. If successful, this technology could be incorporated into existing cardiac catheterization lab workflows and dramatically alter the standard of care.
Conclusion: A Turning Point in the Fight Against MVO
The approval of the MOCA-II IDE trial marks a turning point for patients, clinicians, and researchers fighting against the persistent burden of microvascular obstruction. CorFlow’s CoFI system offers the first real opportunity to diagnose and eventually treat this condition during the critical window of a heart attack.
Through close collaboration with world-class experts and research centers, CorFlow is now poised to advance our understanding of MVO and bring urgently needed innovation to one of the most common and devastating medical emergencies faced globally.
As the company moves into the next phase of clinical validation, patients and providers alike can look forward to a future where timely, targeted intervention is possible—and where surviving a heart attack doesn’t have to mean living with long-term complications.
About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications for the unique patented technology.
