Angel Medical Systems Receives CE Mark Approval for the AngelMed Guardian, an Implantable Device Designed to Provide Early Warning of a Heart Attack
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 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.
Forward Looking Statements: Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
SOURCE Angel Medical Systems