Private medical device maker Miracor Medical Systems GmbH won CE Mark approval for its Pressure-controlled Intermittent Coronary Sinus Occlusion System.
In conjunction with the regulatory win, the company announced that it successfully treated its 1st patient, a U.K. woman who suffered a large acute heart attack.
The PISCO system, implanted via a balloon catheter inserted into the coronary sinus, is designed to improve acute coronary syndrome revascularization following primary percutaneous coronary intervention. The technology has the potential to restore the function of muscle tissue following heart attacks or heart failure, according to Miracor.
The PICSO procedure was performed by interventional cardiologist Dr. Magdi El-Omar at Manchester Royal Infirmary in Manchester, England, and the patient, a 38-year-old female, was discharged from the hospital after the surgery.
"A successful coronary angioplasty is not adequate in up to 40% of STEMI patients in whom suboptimal myocardial reperfusion still persists, despite achievement of normal epicardial vessel flow," CEO Jon Hoem said in prepared remarks. "This unsatisfactory outcome is unequivocally linked to adverse outcomes in these patients, including death and heart failure."
The company’s 40-patient Prepare Ramses study is currently underway and expected to further demonstrate positive outcomes of the heart device, Hoem added.
The company last September secured $10 million in the first closing of a series B financing round.