Miracor Medical's PiCSO Impulse System Granted FDA Breakthrough Device Designation

August 22, 2019—Miracor Medical SA announced that it has been granted Breakthrough Device designation by the FDA for its PiCSO Impulse system for pressure-controlled intermittent coronary sinus occlusion to treat ST-segment elevation myocardial infarction (STEMI) patients. Miracor Medical, which is based in Belgium, developed the PiCSO Impulse system for treatment after acute myocardial infarction (AMI). The FDA designation is intended to speed the time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions.

According to the company, PiCSO therapy is applied during percutaneous coronary intervention (PCI) in patients experiencing STEMI. The device clears the coronary microcirculation by intermittently occluding the coronary sinus outflow, resulting in improved perfusion of the infarcted area of the heart. The PiCSO Impulse system is intended to reduce infarct size after STEMI, which is strongly associated with reductions in heart failure hospitalizations and reduced mortality.

Professor Gregg Stone, MD, commented in the company's announcement, “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.”

The company stated that FDA Breakthrough Device designation recognizes the novelty of the PiCSO Impulse system and its potential to benefit patients with anterior STEMI. Additionally, the Centers for Medicare & Medicaid Services recently acknowledged the importance of this designation by establishing an alternative reimbursement pathway for products that receive FDA marketing authorization and have Breakthrough designation.

In July 2019, Miracor announced the start of its European PiCSO-AMI-I randomized study to further evaluate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients. The PiCSO Impulse system is not commercially available, advised the company.