Miracor Medical this week said its Pisco Impulse Catheter and Pisco Impulse Console have received CE mark approval.
Pisco therapy is delivered by interventional cardiologists in a primary percutaneous coronary intervention procedure in patients that are experiencing anterior ST-elevated myocardial infarction.
The system works to reduce the infarct size by intermittently occluding the coronary sinus outflow leading to improved microcirculatory function.
Miracor Medical said the device has shown improvement of coronary microvascular function post-treatment with a significantly lower index of microcirculatory resistance at 24 to 48 hours when compared to controls.
“We are very excited to have CE Mark for the next-generation PiCSO Impulse System. This was an intense effort by everyone at Miracor and I wish to congratulate the Miracor team, our physician partners and clinical steering committee members for this achievement. The CE Mark is a great milestone and our market access strategies over the next 12-18 months will generate new clinical data and facilitate the commercial roll-out in the second half of 2021,” CEO Olivier Delporte said in a news release.
The company is currently recruiting patients in a landmark European randomized controlled trial to further demonstrate the benefits of Pisco therapy when compared with conventional PCI to treat anterior STEMI patients.
