|16/02/10||Miracor achieves EN ISO 13485 certification|
VIENNA-February 16, 2010 – Miracor Medical Systems, a company developing the PICSO® 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 (PICSO®) technology aims to redistribute flow after a heart attack. Using PICSO®, 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 PICSO® Impulse System is the only fully automated system able to intermittently occlude the venous outflow from the heart. Using the Miracor PICSO® 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. PICSO® 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 PICSO® 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 PICSO® technology.
To receive more news on Miracor please sign up for news releases on www.miracormedical.com.
View the certificate here: Miracor QA System EN ISO13485 2003 certificate 120210.pdf
Miracor Medical System’s PICSO® System to be showcased at ‘OneMedForum San Francisco’ investor conference, January 9, 2013, 12:20 p.m. PST
receive news alerts
Last updated: 21/05/13Miracor Medical Systems GmbH, Gumpendorferstr. 139 Top 1.05, A-1060 Vienna · t +43 (0) 1 - 236 65 76 - 0 · f +43 (0) 1 - 236 65 76 - 22 · office[at]miracormedical.com