Miracor Medical's PiCSO Impulse System Receives FDA Breakthrough Device Designation for STEMI Treatment

On August 26, 2019, VCBeat (WeChat ID: vcbeat) learned that the FDA had granted Breakthrough Device designation to Miracor Medical’s PiCSO Pulse System, a device used for the treatment of ST-segment elevation myocardial infarction (STEMI).Patient.

The FDA’s Breakthrough Device designation is designed to accelerate the market availability of devices that treat life-threatening or irreversibly debilitating diseases. The FDA has recognized the novelty of the PiCSO Pulse System and its benefits for patients with ST-elevation myocardial infarction (STEMI). The Centers for Medicare & Medicaid Services (CMS) has also recently acknowledged the significance of this designation and established an alternative reimbursement pathway for products that have obtained FDA marketing authorization and hold Breakthrough Device designation.

During percutaneous coronary intervention (PCI), interventional cardiologists administer PiCSO therapy to patients with ST-segment elevation myocardial infarction (STEMI). The PiCSO Pulse System improves perfusion in the infarcted myocardial region by intermittently obstructing coronary sinus outflow, thereby enhancing coronary microcirculation. This mechanism of action is unique and distinctive.

The PiCSO Pulse System is designed to reduce the infarct size in patients with ST-elevation myocardial infarction (STEMI), thereby lowering hospitalization rates for heart failure and mortality. Within 90 days of a confirmed STEMI diagnosis, 18–28% of patients develop heart failure. Despite improvements such as reperfusion strategies and adjunctive pharmacological therapy, the one-year mortality rate among STEMI patients remains as high as 14%.

Olivier Delporte, CEO of Miracor Medical, stated: “This breakthrough certification demonstrates the FDA’s commitment to encouraging medical device innovation, meeting clinical needs, and improving patient care; it also underscores the necessity of enhancing care for STEMI patients, which will facilitate Miracor Medical’s growth in the United States.”

Professor Gregg Stone of New York State, USA, stated, “Even with effective treatment, STEMI patients remain prone to severe cardiac events leading to heart failure. Early studies have shown that PiCSO may reduce infarct size in STEMI. The breakthrough designation by the FDA indicates the need to adopt therapies such as PiCSO to reduce infarct size in STEMI patients.”

In July this year, Miracor Medical announced the initiation of its European randomized controlled study project, PiCSO-AMI-I, to further evaluate the efficacy of PiCSO therapy versus conventional PCI therapy in patients with STEMI.

Headquartered in Awans, Belgium, Miracor Medical provides innovative solutions for the treatment of severe heart disease, aiming to improve short- and long-term clinical outcomes and reduce associated costs. Miracor Medical has developed the PiCSO Pulse System, the only medical device indicated for coronary sinus intervention therapy. By clearing microcirculatory obstruction and reducing the incidence of heart failure after acute myocardial infarction, the system reduces infarct size and improves cardiac function.

(Compiled by Tian Shuhang)