Angel Medical Systems has received CE (Conformite Europeenne) mark approval for the commercial sale of 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, which connects to the heart using a standard pacemaker lead and 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 US in the Alerts Phase II clinical study under an investigational device exemption (IDE) from the US Food and Drug Administration.
AngelMed chief executive officer David Fischell said that winning CE mark approval in Europe offers a new avenue for their company to gain distribution, establish reimbursement networks, and to build relationships with thousands of cardiologists throughout the EU.