Clinical and Industry News

Compiled by Cath Lab Digest

Compiled by Cath Lab Digest

Early Heart Attack Detection Device Developed by Angel Medical Systems

ALERTS Pivotal Study will assess safety and effectiveness

The AngelMed Guardian system is designed to track significant changes in the heart’s electrical signal and alert patients to seek medical attention, reducing the time it takes patients to get to the emergency room during an impending heart attack. The system is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals. The first implant in the state of New York was performed by Dr. Hashmat Ashraf, of Kaleida Health, in Buffalo, New York. Dr. Ashraf was among the very first physicians in the United States to implant the experimental device.

An ongoing trial, the ALERTS Pivotal Study, will provide an assessment of the safety and effectiveness of the AngelMed Guardian System. David Garland, a 7th grade teacher in Buffalo, New York, is the first patient in New York enrolled in the ALERTS study to receive the AngelMed Guardian System. Mr. Garland had a heart attack in July 2011 and underwent stent placement. He has a strong family history of heart disease; his symptoms included fatigue and “indigestion-like” pain, and had symptoms for weeks before his heart attack. Mr. Garland was successfully implanted with the device by Dr. Ashraf at Millard Fillmore Gates Hospital in Buffalo.

According to the American Heart Association, one of every five deaths in the US is attributable to coronary heart disease. Furthermore, 50% of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

Buffalo Heart Group of Buffalo, New York, is among the first medical facilities to participate in the AngelMed Guardian system trial. To participate in the ALERTS study, patients must meet various inclusion criteria.

For more information on the AngelMed Guardian system or the ALERTS study protocol, contact Marcia Makoviecki of Angel Medical Systems @ (732) 542-5551 x205.