Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of heart attack.
The PiCSO (pressure-controlled intermittent coronary sinus occlusion) system is designed to clear coronary microcirculation by intermittently stopping the delivery of blood through the coronary sinus into the right atrium. The intended result is improved blood flow to the obstructed area of the heart, reducing the size of that area after an ST-elevation myocardial infarction (STEMI) heart attack.
In September 2018, Miracor secured $34.6 million in Series D funding for the development and commercialization of the PiCSO system.
“The breakthrough designation demonstrates FDA’s continued commitment to encouraging medical device innovation to address clinical needs and improve patient care,” CEO Olivier Delporte said in prepared remarks. “This designation highlights the need for improving care of STEMI patients and will help Miracor accelerate the pathway in the USA.”
“Despite effective treatment, patients with STEMI often have large heart attacks, resulting in heart failure,” added Dr. Gregg Stone, of New York City’s Columbia University. “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.”