News | January 15, 2009

ALERTS Study to Evaluate Efficacy of Implantable Devices in High-Risk Patients

January 16, 2009 - AngelMed announced Phase II of the ALERTS trial for the AngelMed Guardian implantable cardiac monitor and alert system, and is actively seeking up to 50 U.S. clinical sites to participate in the trial.

Designed to reduce time to presentation by detecting significant changes in the heart's electrical signal and then alerting patients to seek medical attention, the AngelMed Guardian System is commercially available in Brazil and available for investigational use only in the U.S.

According to the American Heart Association, one of every five deaths in the U.S. is attributable to coronary heart disease. Further, fifty percent of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

The AngelMed Guardian 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 ALERTS trial is currently underway and will be conducted in up to 50 centers across the U.S. According to AngelMed’s CEO, David Fischell, Ph.D., the ALERTS trial is designed to test the Guardian's ability to detect in a clinical setting the electrical shift that occurs during a heart attack and then provide an early warning to patients that could potentially save their lives.

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