Healthcare Industry News: Acute Coronary Syndrome
News Release - November 9, 2010
Miracor reports successful first-in-man clinical outcome for its PICSO(R) system designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI)‘Prepare PISCO®’ study underway at the Academic Medical Center, Amsterdam
“Nearly 30% of heart attack patients have suboptimal microcirculatory blood flow even after coronary angioplasty, increasing their risk of death within a year by almost three-fold. PICSO® is designed to help these patients.”
Jon H. Hoem, CEO, Miracor Medical Systems
VIENNA, Austria--(Healthcare Sales & Marketing Network)-- Miracor Medical Systems GmbH announced today the successful first-in-man clinical outcome for its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System, designed to improve Acute Coronary Syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI).
The PICSO® procedure was performed in one patient by Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, The Netherlands, as part of the projected 10-patient ‘Prepare PISCO®’ study of stable angina patients. It is planned that Miracor will initiate the Pivotal RAMSES Study of PICSO® upon the successful completion of the current study.
“We needed only three minutes from femoral vein puncture to safe insertion of the PICSO® catheter into the coronary sinus,” said Prof. Piek. “This proves the ease of insertion at a site that is familiar to us, which is important as we expand the use of PICSO® to more critically ill patients. The new PICSO® catheter is easily maneuverable and is totally stable during the procedure. We also observed increases in myocardial perfusion pressure during brief coronary occlusion as well as a marked reduction of ischemia as assessed by the surface ECG ST-segment shift, documenting that PICSO® has a potential cardioprotective effect. We therefore met both study end-points in this first patient, which is very encouraging as we continue to enroll patients into the study,” added Prof. Piek.
“These findings corroborate the reduction of ischemia by the application of PICSO® as it was documented experimentally and verified by earlier clinical series,” said Prof. DDr. Werner Mohl the inventor of the PICSO® concept and Founder of Miracor.
“This first-in-man event is a critically important milestone for Miracor and PICSO® and I am very pleased that the patient is doing well. We look forward to successfully completing the ‘Prepare PICSO®’ study and then leveraging the results into the Pivotal RAMSES Study of PICSO® next year,” said Jon H. Hoem, Miracor CEO. “There is a dire, unmet clinical need for PICSO®: nearly 30% of the critical heart attack patients have suboptimal microcirculatory blood flow even after coronary angioplasty, increasing their risk of death within a year by almost three-fold. PICSO® is designed to help these patients.”
Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Clearly, primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Paradoxically, the process of restoring coronary blood flow can in itself exacerbate the myocardial injury. Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) system offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The PICSO® system consists of the Miracor PICSO® Impulse Console and the disposable, single-use Miracor PICSO® Impulse Catheter.
About Miracor Medical Systems GmbH
Based in Vienna, Austria, privately held Miracor is commercializing a unique and potentially disruptive technology, PICSO®, for Acute Coronary Syndrome (ACS), heart failure, and cardiac surgery patients. The Company’s objective is to establish PICSO® as the standard of care for heart attack patients, thereby improving their quality of life. The initial market opportunity for PICSO® is 30% of all ACS patients treated per year, which translates into more than 350,000 patients in the U.S. and Europe.
NOTE: The Miracor PICSO® Impulse System is for investigational use only at this time.
Source: Miracor Medical Systems
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