Miracor Medical SA has been granted Breakthrough Device Designation by the U.S.FDA for its PiCSO Impulse Systemfor treatment of STEMI patients.
The FDA BreakthroughDevice designation isintendedto speed time to market for treatments oflife-threatening or irreversibly debilitating diseases or conditionsand recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with anterior STEMI heart attacks. The Centers for Medicare & Medicaid Services (CMS)also recently acknowledged the importance of this designation by establishing an alternative reimbursement pathway for products that receive FDA marketing authorization and held the Breakthrough Designation
PiCSOtherapy isprovided by interventional cardiologists during PCI (Percutaneous Coronary Intervention) in patients experiencing ST-elevated myocardial infarction (STEMI). The PiCSOImpulse System clears the coronary microcirculationby intermittently occluding the coronary sinus outflowresulting inimprovedperfusion of the infarcted area of the heart. This mechanism of action is unique and very differentiated.
The PiCSOImpulse System is intended to reduceinfarct size after STEMI, which is strongly associatedwithreductions in heart failure hospitalizations and reduced mortality1. Heart failure occurs in18-28% of patients within the first 90 days after STEMI2and the one-year mortality rate for STEMI is 14% despite all improvements and widespread use of reperfusion strategies and adjuvant pharmacological therapies3
“TheBreakthrough Designation demonstrates FDA’s continued commitment to encouraging medical device innovation to address clinical needs and improve patient care. Thisdesignation highlights the need for improving care of STEMI patientsand will helpMiracor acceleratethepathway in the USA.” said Olivier Delporte, CEO.
“Despite effective treatment, patients with STEMI often have large heart attacks, resulting in heart failure. Early studies have shown the potential for PiCSO to reduce infarct size in STEMI. The FDA Breakthrough designation acknowledges the need for therapies like PiCSO that may be able to reduce infarct size in patients with STEMI.”said Prof. Dr. Gregg Stone,NY, USA.
In July of this year, Miracorannouncedthe start of its European randomized study, PiCSO-AMI-I, to further evaluate the benefitsof PiCSOtherapyas compared withconventionalPCI for the treatment of anterior STEMI patients.
About Miracor Medical Miracor
Medical(www.miracormedical.com), located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.Miracor Medical has developedthe PiCSOImpulse System, the first and only coronary sinus intervention designed toreduce infarct size,improve cardiac functionby clearing microcirculationand potentially reduce the onsetof heart failure following acute myocardial infarction.