AWANS, Belgium–(BUSINESS WIRE)–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 […]
Tag: Picso
Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®
AWANS, Belgium, March 29, 2022 /PRNewswire/ — Miracor Medical SA (Miracor Medical) today announced the first patient enrolled in the PICSO-AMI-V study to evaluate the benefits of PiCSO® (Pressure Controlled Intermittent Coronary Sinus Occlusion) therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-Elevation Myocardial Infarction (STEMI). […]
Miracor Medical Raises 24M€
Funds will be used for clinical studies and initiation of commercialization AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has announced the closing of a 24M€ Series-E round of financing. The round was led by a new corporate strategic investor joined by co-investor Yonghua. Current investors Earlybird, Noshaq, Quest for Growth, […]
Miracor Medical’s PiCSO® System Receives CE Mark
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has announced the award of the CE Mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior STEMI patients. The new system features improvements in ease of use. PiCSO therapy is delivered […]
Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases […]
Miracor Medical Starts PiCSO-AMI-I Randomized Study in EU
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) today announced the initiation and first patient enrollment in the PICSO-AMI-I study to evaluate the benefits of PiCSO® therapy compared with conventional PCI for the treatment of anterior STEMI patients. The first patient enrolled into this study was treated at Oxford Heart Center, Oxford, […]
PiCSO therapy reduces infarct size in STEMI patients.
AWANS, Belgium, May 24, 2018 /PRNewswire/ — Miracor Medical SA announced today the clinical results from the physician-sponsored OxAMI-PiCSO study were published in the EuroIntervention journal and presented at the Hotline session of the EuroPCR conference by Dr. Giovanni Luigi De Maria, MD, the Heart Centre, Oxford University Hospitals, Oxford, UK. The latest results, obtained with the PiCSO® Impulse System, contribute to the […]