CorFlow Therapeutics is set to initiate a pivotal trial of its CorFlow CoFl system across US hospitals for patients being treated for heart attacks.
This initiative comes after the receipt of the US Food and Drug Administration’s (FDA) investigational device exemption (IDE) approval for the trial.
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The MOCA-II IDE pivotal trial aims to validate the diagnostic accuracy of the CorFlow CoFl system in detecting microvascular obstruction (MVO) during primary percutaneous coronary intervention (PCI) procedures.
Its primary goal is to compare the CoFl system’s diagnostic readings with cardiac magnetic resonance imaging (MRI) scans.
The trial is being spearheaded by Dr Timothy Henry at The Christ Hospital in Cincinnati, Ohio, US, and Professor Marco Valgimigli at the Cardiocentro Ticino Institute in Lugano, Switzerland.
It will enrol more than 200 ST-elevation myocardial infarction (STEMI) subjects at research institutions in Europe and the US and follows the completion of the first-in-human MOCA-I trial last year.
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By GlobalDataThe CorFlow technology is not only designed to diagnose MVO but also functions as a localised drug delivery system for both diagnostic and therapeutic agents, which is currently under independent research.
CorFlow Therapeutics CEO Paul Mead said: 鈥淭he long history of interventional cardiology and heart attack care breakthroughs 鈥� going back over 100 years 鈥� is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished.
鈥淭he majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. 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 to improving care for these people where we know we can do better.鈥�
Headquartered in Switzerland, CorFlow operates subsidiaries in the US and Italy.
In September 2024, the company secured $48.5m in a Series B funding round to support the advancement of its MVO detection device through a pivotal study.
