"Annually, more than 1.3 million people have a heart attack, yet over 90% do not qualify for an ICD or pacemaker,” says AngelMed’s Chief Medical Officer, Dr. Tim Fischell. “The Guardian has the potential to benefit the very large number of patients."
Chicago, IL (PRWEB) March 22, 2012
Dr. C. Michael Gibson M.S., M.D., Beth Israel Deaconess Medical Center, will present a poster entitled “Size and duration of ischemic events detected using permanent intracardiac ST Segment monitoring: First five years of human experience.” The presentation is scheduled for Sunday, March 25, 9:30-10:30AM, McCormick Place South, Hall A in Chicago. Dr. Gibson co-authored the presentation, along with Vanildo S. Guimarães M.D., M. Sasha John Ph.D., David Keenan, Audes M. Feitosa M.D., Paulo Medeiros M.D., Leopoldo S. Piegas M.D., Mitchell W. Krucoff M.D.; and David Holmes M.D.
Dr. Gibson also serves as Lead Investigator on two large-scale studies of ST Segment monitoring. The St. Jude Medical Analyze ST Study is designed to investigate the safety and effectiveness of ST segment monitoring as an additional feature of the company’s implantable cardioverter defibrillators (ICDs). Similarly, the Angel Medical Systems ALERTS Study is designed to investigate the potential benefits of continuous ST segment monitoring and alerting in advanced coronary artery disease (CAD) patients who are not indicated for an ICD. The AngelMed study uses the Guardian TM implantable heart monitor. Angel Medical Systems and St. Jude Medical collaborated on the unique monitoring algorithms used in both devices.
“These two clinical studies assess both the safety and effectiveness of ST segment monitoring using implantable device technology and may prove it to be effective in early detection and warning of potentially life-threatening ischemia,” said Dr. Gibson. “This would allow us to shift the paradigm for treatment closer to the onset of the cause of the heart attack and could improve clinical outcomes.”
"We know that ST segment changes can help us to identify CAD events, and that patients with ICDs often also have CAD, so the continuous, internal ST segment monitoring that is possible with this technology could provide physicians of those patients with an early warning signal when a patient is experiencing an ischemic event," said Dr. Mark Carlson, Chief Medical Officer and Senior Vice President of Research and Clinical Affairs for the St. Jude Medical Cardiac Rhythm Management Division.
The studies are occurring at multiple centers throughout the country with some centers participating in both studies simultaneously, thereby offering the technology to the largest possible patient population.
Half of patients experiencing a heart attack have no symptoms (silent myocardial infarction) or atypical symptoms that cause confusion or delay about seeking care. Even including patient with symptoms, average pre-hospital delay is over 3 hours because patients wait to call 911. This delay helps result in more than half of MI deaths occurring before reaching a hospital. The American Medical Association indicates that 18% of men and 35% of women experience a second MI within six years of having a recognized first attack. CAD needs to be managed on an ongoing basis to avoid reoccurring life threatening acute coronary events. Furthermore, approximately two-thirds of ICD patients have cardiac ischemia, with many more having risk factors for developing cardiovascular disease.
The AngelMed Guardian System™ heart monitor is designed to track significant changes in the heart's electrical signal from a standard pacemaker lead, identify the signature of acute thrombotic occlusions when they occur, and then alert the patient directly to seek medical attention. The device is being studied in high risk heart patients who do not qualify for an ICD, but who have had a STEMI, NSTEMI or unstable angina in their recent past. "Annually, more than 1.3 million people have a heart attack, yet over 90% do not qualify for an ICD or pacemaker,” says AngelMed’s Chief Medical Officer, Dr. Tim Fischell. “The Guardian has the potential to benefit the very large number of patients with this need.”
The Analyze ST Study is a pivotal IDE investigation of up to 5,228 patients at approximately 200 medical centers. The ALERTS Study is a pivotal IDE investigation of up to 1020 patients in 75 medical centers. To participate in the either study, patients must meet various inclusion criteria. For more information on the AngelMed Guardian System or the ALERTS study protocol, contact David Keenan, Vice President of Clinical and Regulatory Affairs at (732) 542-3350, or visit http://www.angel-med.com. For information on the St. Jude Medical Analyze ST Study, contact Tamara Shipman, Director of Clinical Affairs at (408) 552-6410.
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.