The CE Mark signals that a product is in compliance with all relevant EU legislation, making it eligible to be marketed and sold throughout the EU. The AngelMed Guardian is commercially available in Brazil and is currently being tested in the United States in the ALERTS Phase II Clinical Study under an investigational device exemption (IDE) from the FDA.
Dr. C. Michael Gibson of Harvard Medical School, who is leading the ALERTS study says, "Over the past two decades, it has routinely taken patients 2-3 hours to arrive at the hospital with a heart attack. Our initial studies indicate that this device may reduce that time to approximately 20 minutes. When time is muscle, every minute counts and our hope is that survival will be improved."
Dr. David Fischell, Chief Executive Officer of AngelMed adds, "Winning CE Mark approval in Europe offers a new avenue for our company to gain distribution, establish reimbursement networks, and to build relationships with thousands of cardiologists throughout the EU. The incidence of death from heart attacks is continuing to grow across Europe and the shortened time to treatment for heart attack that can result from early warning has the potential to reduce damage to the heart from heart attacks and save lives."
For more information on the AngelMed Guardian System or the ALERTS study, to go to http://www.angel-med.com.
SOURCE Angel Medical Systems