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. It says the new system features improvements in ease of use.
PiCSO therapy is delivered during primary percutaneous coronary intervention (PCI) in patients experiencing anterior ST-elevated myocardial infarction (STEMI).
A press release from the company says that, via its unique mechanism of action, the PiCSO Impulse System reduces infarct size by intermittently occluding the coronary sinus outflow leading to improved microcirculatory function. Infarct size is strongly associated with reductions in heart failure hospitalisations and reduced mortality.
The CE mark file was supported by clinical data from both the PiCSO in ACS study, and the OxAMI-PiCSO study.
“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.” said Olivier Delporte, CEO at Miracor.
The company says it is currently recruiting patients in a landmark European randomised controlled trial, PiCSO-AMI-I, to further demonstrate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients.
Miracor describes the PiCSO Impulse System as the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.