VIENNA–(BUSINESS WIRE)–Miracor Medical Systems
GmbH announced today that data will be reported during next weeks “TCT
(Transcatheter Cardiovascular Therapeutics) 2011” scientific meeting in San Francisco. The data
show that the PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion)
system is safe and feasible during elective percutaneous coronary intervention
(PCI) using a femoral vein approach. (Click here for 5 minute “Corporate Preview” video with PICSO®
animation.)
The PICSO® procedure was performed successfully on 10
patients by Prof. Dr. med. Jan Piek and his group at the Academic
Medical Center,
Amsterdam, The
Netherlands, as part of the ‘Prepare PISCO® study of stable angina patients.
Based on these outstanding clinical results, Miracor will soon initiate the
‘Prepare RAMSES study in acute coronary syndrome patients.
“In spite of a successful primary PCI, suboptimal myocardial
reperfusion occurs in approximately 30 percent of STEMI patients, and this
occurrence is strongly correlated with unfavorable outcomes for patients,” said
Prof. Piek. “Our study demonstrates that PICSO significantly increased the
redistribution of blood into the ischemic myocardium, which is very encouraging
as we look to enroll patients into the multi-centre ‘Prepare RAMSES study,”
added Prof. Piek.
Prof. Pieks results will be presented during a special
spotlight session on ‘Approaches to Reperfusion Injury and Enhancing Myocardial
Recovery moderated by Dr. Mitchell W. Krucoff (Duke University Medical Centre,
Durham, NC) and Dr. Holger Thiele (University of Leipzig Medical Center,
Germany).
“We are extremely pleased to have successfully completed the
‘Prepare PICSO® study and now look forward with great enthusiasm to the
‘Prepare RAMSES study ,” said Jon H. Hoem, Miracor CEO. “The ‘Prepare RAMSES
study will help us understand the logistics of the technology in an acute
setting and also how the technology effects important endpoints such as infarct
size, ST-segment ECG changes, enzyme release and left ventricular function.”
About PISCO® and cardioprotected PCI (cPCITM)
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. Recent studies have also
shown that reduced door-to-balloon time does not reduce mortality in STEMI
patients. Miracors Pressure-controlled Intermittent Coronary Sinus Occlusion
(PICSO®) Impulse System offers a new and innovative approach to reduce
myocardial injury and to revitalize ischemic myocardium thereby providing a
cardioprotective effect called cardioprotected PCI (cPCITM). 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
Companys 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.
The Miracor PICSO® Impulse System is CE-marked and can be
used during coronary revascularization procedures following myocardial
infarction and other types of acute coronary syndromes to intermittently
increase the pressure in the coronary venous system. The technology is for
investigational use only in the United
States at this time.