Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Wednesday, August 24, 2022

Miracor Medical SA has received FDA approval for an Investigational Device Exemption (IDE), allowing the company to commence a pivotal study using its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The multicenter, randomized trial, known as PiCSO-AMI-II, will enroll 300 patients who have anterior ST-segment Elevation Myocardial Infarction (STEMI) with TIMI flow 0, 1, and 2 within 12 hours of symptom onset. The primary efficacy endpoint of the study will be the measurement of infarct size using cardiac magnetic resonance imaging (CMR) at 5 days. The primary safety endpoint will be a performance goal for adverse events related to the device and procedure at 30 days. Acute major adverse cardiac events and heart failure endpoints will also be evaluated for up to 3 years.

PiCSO-AMI-II will be the second major randomized trial to assess the role of PiCSO in improving coronary microvascular function and reducing infarct size in patients with anterior STEMI. Miracor is currently enrolling 144 patients in PiCSO-AMI-I, a significant European randomized controlled trial that shares similar endpoints with the approved US trial. Recruitment for the European study is expected to conclude this summer. It is anticipated that a future meta-analysis of patient-level data from both studies will demonstrate an improvement in hard clinical endpoints related to heart failure hospitalization.

PiCSO is utilized as an adjunctive procedure following the restoration of epicardial flow during primary percutaneous coronary intervention (PCI). By intermittently occluding the coronary sinus outflow, PiCSO redistributes venous blood flow to the peri-infarct zone, enhancing the viability of the coronary microcirculation by removing debris and other harmful agents associated with the infarct process. Early non-randomized European studies have suggested that this approach reduces the incidence of coronary microvascular obstruction (MVO) and results in smaller infarct size, both of which are strongly correlated with improved outcomes in terms of heart failure hospitalizations and reduced mortality following primary PCI. Despite advancements in patient care, the use of reperfusion strategies, and adjuvant pharmacological therapies, the one-year mortality rate for high-risk patients after STEMI has plateaued at 14% in the past decade. Additionally, the development of heart failure following hospital discharge is prevalent, with approximately 13% of patients diagnosed within 30 days and 20-30% within one year after discharge.

Prof. Gregg W. Stone, Director of Academic Affairs for the Mount Sinai Heart Health System in New York, NY, USA, and Prof. Marco Valgimigli of Istituto Cardiocentro Ticino in Lugano, Switzerland, will serve as the study's principal investigator and co-principal investigator, respectively. Prof. Stone emphasized the importance of reducing infarct size and MVO in improving survival and decreasing heart failure risk among heart attack patients. He expressed optimism about the potential of PiCSO therapy and the FDA-approved randomized IDE trial, which has been designed to validate the safety and effectiveness of PiCSO.

Olivier Delporte, CEO of Miracor, highlighted the company's positive progress and the significance of the Investigational Device Exemption, in addition to the ICD-10-PCS code granted by the Centers for Medicare and Medicaid Services (CMS) in April 2022. Delporte stated that the company looks forward to conducting a meticulous study with its clinical investigators to make PiCSO available to American patients. Miracor plans to raise funds later this year to support the execution of the study, company operations, and explore potential partnerships in Asia.

The PiCSO Impulse System obtained 'Breakthrough Designation

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