Miracor's PICSO Device Receives ISO Certification

Dateline: 16 February 2010

VIENNA – Miracor Medical Systems, a company developing the PICSOTM technology for heart attack patients, has been awarded EN ISO 13485:2003 certification for its quality management system by the certification authority TÜV Süd. The international standard for the medical device industry, EN ISO 13485:2003, verifies Miracor’s ability to provide medical devices that consistently meet customer needs and regulatory requirements.

Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSOTM) technology aims to redistribute flow after a heart attack. Using PICSOTM, physicians can improve the outcomes of critically ill patients suffering from a heart attack.

“The ISO 13485 certification is an important step to establish PICSO as a standard of care for heart attack patients and is the foundation for successful product development and clinical trials,” said Jon H. Hoem, Chief Executive Officer of Miracor. “We are pleased to have completed the first patients in our European clinical trial and look forward to continue using the PICSO technology in new studies and patients groups.”

The Miracor PICSOTM Impulse System is the only fully automated system able to intermittently occlude the venous outflow from the heart. Using the Miracor PICSOTM Impulse Catheter, interventional cardiologists can provide improved care to heart attack patients. These patients normally undergo a stent procedure which opens the occluded coronary artery thereby re-establishing flow into the heart tissue. However, the stent procedure does not eliminate the risk for future complications and a large number of patients need additional treatment. PICSOTM holds the promise to reduce complications and costs after a stent procedure. More than 400,000 critically ill heart attack patients are treated annually in the United States alone. 

The PICSOTM Impulse System has undergone extensive preclinical testing in Europe and Miracor will enter into several clinical trials to document the safety and efficacy of the PICSOTM technology.
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About Miracor:
Established in May 2008, Miracor Medical Systems GmbH is a medical device company founded to develop and commercialize Pressure-controlled Intermittent Coronary Sinus (PICSOTM) technology for the treatment of heart attack patients.

The PICSO™ procedure intermittently occludes venous outflow from the heart muscle. This increases coronary sinus pressure and redistributes blood flow into the damaged (infarct) zone of the heart. PICSO™ has the potential to improve outcomes for ACS patients by reducing infarct size and revitalizing damaged heart tissue. PICSO™ may also be of benefit to heart failure and cardiac surgery patients.

The company estimates that the initial market opportunity for PICSO™ is 30% of all heart attack patients. This patient group represents more than 350,000 patients annually world-wide. The Company has raised €6.0M (USD 8.5M) from two European venture capital funds: Earlybird (www.earlybird.com); and Delta Partners (www.deltapartners.com).

For further information, please contact:

Jon H. Hoem, CEO
jhoem@miracormedical.com

Miracor Medical Systems GmbH
Mariannengasse 14/14
A-1090 Vienna, Austria
Telephone: +43 (0) 123 665 7611
Fax: +43 (0) 123 665 7621

www.miracormedical.com  

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