Miracor Announces UK Studies of the PICSO Impulse System

March 31, 2015—Miracor Medical Systems announced that two clinical investigations are being conducted in the United Kingdom for the PICSO (pressure-controlled intermittent coronary sinus occlusion) Impulse system to treat patients with myocardial infarction (MI). The company has also established a sales subsidiary in Manchester, United Kingdom to support further commercialization of its devices.

In July 2014, the company announced CE Mark approval and the launch of the next-generation PICSO system, with patients treated in the United Kingdom, Ireland, and Hungary.

The company noted that recently presented data show that PICSO, as an adjuvant treatment to primary percutaneous coronary intervention (PCI), may significantly reduce infarct size in patients presenting with acute ST-segment elevation myocardial infarction (STEMI). Coinvestigator Tim P. van de Hoef, MD, presented the data from the prospective, multicenter, safety and feasibility PREPARE RAMSES study at the TCT 2014: Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC.

The two clinical studies in the United Kingdom are further evaluating the effectiveness of PICSO therapy in MI patients.

The PICSO IN STEMI study is currently being conducted in the United Kingdom by Prof. Azfar Zaman, MD, and Mohaned Egred, MD at the Freeman Hospital in Newcastle upon Tyne; by Nick Palmer, MD, at the Liverpool Heart and Chest Hospital; and by Ever Grech, MD, at Northern General Hospital, Sheffield.

A physician-initiated study evaluating the effectiveness of PICSO in patients with non-ST-segment elevation myocardial infarction (NSTEMI) is being conducted by Piers Clifford, MD, at the Wycombe Hospital in High Wycombe, Buckinghamshire in the United Kingdom. Further centers are currently in the training phase for both studies, advised the company.

Prof. Zaman, who is chief investigator of the study, commented in the company’s press release, “The study is designed to explore the improvement of microvascular perfusion and cardiac function in acute myocardial infarction patients, which remains a large unmet need. PICSO can be applied during PCI even in the acute setting and therefore has the potential to change the way we currently treat such patients and thereby improve outcomes in this huge patient population.”

Dr. Clifford commented, “Microvascular obstruction, which is very common in STEMI patients, can also be observed in the NSTEMI patient population. PICSO has shown to reduce [microvascular obstruction] in STEMI patients and we therefore are convinced that PICSO may also represent a useful intervention in this even larger patient population, with the potential to improve patient prognosis and reduce healthcare expenditure.”