FDA Approved IDE for Picso® Pivotal Study of Miracor Medical
On August 23, 2022, Miracor Medical SA, a provider of innovative solutions for the treatment of severe cardiac diseases, announced that the FDA has approved an Investigational Device Exemption (IDE), allowing the company to begin 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) who have TIMI flow 0, 1, or 2 within 12 hours of symptom onset. At 5 days, the primary efficacy endpoint will be infarct size as measured b...
