Miracor Medical’s PiCSO Pivotal Study Receives FDA IDE Approval

August 30, 2022—Miracor Medical SA, which is based in Awans, Belgium, recently announced FDA approval of an investigational device exemption (IDE) that will allow the company to initiate the pivotal PiCSO-AMI-II study of PiCSO, its pressure-controlled intermittent coronary sinus occlusion technology.

PiCSO is used as an adjunctive procedure after epicardial flow has been restored during primary percutaneous coronary intervention. By intermittently occluding the coronary sinus outflow, the device redistributes venous blood flow to the peri-infarct zone and enhances the coronary microcirculation viability by washing out debris and other noxious agents of the infarct process.

According to Miracor, the multicenter PiCSO-AMI-II randomized trial will enroll 300 patients with anterior ST-segment elevation myocardial infarction (STEMI) presenting with thrombolysis in myocardial infarction (TIMI) flow 0, 1, and 2 within 12 hours of symptom onset.

The primary efficacy endpoint of the study will be infarct size measured by cardiac MRI at 5 days. The primary safety endpoint is a performance goal for device- and procedure-related adverse events at 30 days. Major adverse cardiac events and heart failure endpoints will be captured acutely and for up to 3 years.

The study’s Principal Investigator is Gregg W. Stone, MD, Director of Academic Affairs for the Mount Sinai Heart Health System in New York, New York. Professor Marco Valgimigli, MD, of Istituto Cardiocentro Ticino in Lugano, Switzerland, is the study Coprincipal Investigator.

“Reducing infarct size and microvascular obstruction is a key factor in improving survival and reducing the risk of heart failure among patients with heart attack,” commented Dr. Stone in the company’s press release. “PiCSO therapy is a promising new therapy to reduce infarct size and improve outcomes in anterior STEMI patients. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.”

The company noted that PiCSO-AMI-II will be the second major randomized trial to evaluate the role of its PiCSO technology in improving coronary microvascular function and reducing infarct size in patients presenting with anterior STEMI. Miracor is currently recruiting 144 patients in PiCSO-AMI-I, a European randomized controlled trial with comparable endpoints as the United States trial.

Recruitment in the European study is expected to end this summer. It is anticipated that a future patient-level pooled meta-analysis of the two studies will demonstrate a hard clinical endpoint improvement in heart failure hospitalization.

In the United States, the PiCSO Impulse system is limited to investigational use. It received FDA Breakthrough Device designation in 2019. In Europe, the PiCSO Impulse system initially received European CE Mark approval in 2010, which was reissued in 2020.