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Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI- II multicenter, randomized trial will enroll 300 patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) presenting with 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 magnetic resonance imaging (CMR) 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220823005069/en/
PiCSO® Impulse Catheter (Photo: Business Wire)
PiCSO-AMI-II will be the second major randomized trial to evaluate the role of PiCSO 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 landmark European randomized controlled trial, with comparable endpoints as the approved US 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.
PiCSO is used as an adjunctive procedure after epicardial flow has been restored during the primary percutaneous coronary intervention (PCI) procedure. The unique mechanism of action, of intermittently occluding the coronary sinus outflow, redistributes venous blood-flow …
Full story available on Benzinga.com
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