Miracor completes PICSO System pilot study in patients with ACS

Miracor Medical Systems GmbH announced today the successful completion of the pilot study of its PICSO^® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI).

The "Prepare PICSO^®" pilot study of stable angina patients included ten (10) patients of principal investigator Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, The Netherlands. It is planned that Miracor will now initiate the pivotal RAMSES clinical trial of PICSO^®.

"For all ten patients, we needed less than fifteen minutes from femoral vein puncture to safe insertion of the PICSO^® catheter into the coronary sinus," said Prof. Piek. "Thus, PICSO^® is simple to insert at a site that is very familiar to us. Also, the PICSO^® catheter is easy to maneuver and is continuously stable during the PCI procedure. We were especially pleased to observe a notable reduction of ischemia as documented by the surface ECG ST-segment shift in several patients, clearly suggesting that PICSO^® has a potential cardioprotective benefit. In summary, the findings in this pilot study are extremely encouraging as we now look forward to the broader RAMSES clinical study," added Prof. Piek.

"These first-in-man (FIM) clinical data affirm the diminishment of ischemia with the use of PICSO^®," said Prof. DDr. Werner Mohl, inventor of the PICSO^® concept and Founder of Miracor.

"Successful completion of our "Prepare PICSO®" pilot study is a major milestone for Miracor," said Jon H. Hoem, Miracor CEO. "We are especially pleased that all ten patients are doing well. We now look forward with great anticipation to leveraging these results in our pivotal RAMSES clinical trial of PICSO^®, which we expect to commence later in 2011. We will keep our momentum, because there is a dire, unmet clinical need for PICSO^®: nearly 30% of critical heart attack patients have suboptimal microcirculatory blood flow even after coronary angioplasty, which increases their risk of death within a year by almost three-fold. PICSO^® is designed to help these patients."