Miracor Medical has been granted Breakthrough Device Designation by the FDA for its PiCSO Impulse System for treatment of ST-segment elevation myocardial infarction (STEMI) patients. The PiCSO impulse system is designed to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. A press release reports that this mechanism of action is unique and very differentiated.

The PiCSO impulse system is intended to reduce infarct size after STEMI; the press release note that a reduction in infarct size (post STEMI) is strongly associated with reductions in heart failure hospitalisations and reduced mortality.

Olivier Delporte, CEO, comments: “The Breakthrough Designation demonstrates FDA’s continued commitment to encouraging medical device innovation to address clinical needs and improve patient care. This designation highlights the need for improving care of STEMI patients and will help Miracor accelerate the pathway in the USA.”

Gregg Stone (Columbia University Medical Center, NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, USA) comments: “Despite effective treatment, patients with STEMI often have large heart attacks, resulting in heart failure. Early studies have shown the potential for PiCSO to reduce infarct size in STEMI. The FDA Breakthrough designation acknowledges the need for therapies like PiCSO that may be able to reduce infarct size in patients with STEMI.

In July of this year, Miracor announced the start of its European randomised study—PiCSO-AMI-I—to further evaluate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients.