SHREWSBURY, N.J., Sept. 22 /PRNewswire/ -- Angel Medical Systems announced today that it has received CE (Conformite Europeenne) Mark approval for the commercial sale of The AngelMed Guardian System in Europe. The Guardian System is an implantable early warning system designed to detect coronary occlusion from thrombotic events such as plaque ruptures and alert the patient, often before symptom onset. The System is comprised of an internal implantable device about the size of a pacemaker with vibrational alerting. The implant connects to the heart using a standard pacemaker lead. External alerting is also provided by a pager-like external alerting device.
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
|SOURCE Angel Medical Systems|
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