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|Medtronic Announces Results of Early Feasibility Studies Supporting New Approach to ICD Therapy During Cardiostim 2016|
Places ICD Leads Under Rib Cage, Outside Heart and Veins
DUBLIN and NICE, FRANCE - JUNE 8, 2016 - Medtronic plc (NSYE: MDT) today announced results from several feasibility studies evaluating a new approach to implantable cardioverter defibrillator (ICD) therapy at CARDIOSTIM / EHRA EUROPACE 2016, the World Congress in Electrophysiology and Cardiac Techniques, in Nice, France.
The Medtronic EV-ICD System, which currently is in development and not available for use or sale, is a new approach to ICD therapy with leads placed outside the heart and veins, and under the rib cage. The studies presented are the first to evaluate the new concept, and the results demonstrate that "extravascular" lead placement may provide the same benefits achieved with conventional ICDs, including pacing the heart in patients at risk of dangerous heart rhythms.
The Medtronic EV-ICD system in development consists of an implanted device, a newly designed lead, and procedure tools to guide the efficient delivery of the system. Like conventional ICDs, the system is designed to deliver life-saving electrical shocks to protect patients from sudden cardiac death, to deliver anti-tachycardia pacing (ATP) to pace the heart out of potentially life-threatening heart rhythms that can lead to sudden cardiac death, and to provide post-shock pacing. Similar to transvenous ICD systems, the Medtronic EV-ICD is projected to have longevity of approximately 10 years and an expected device volume of approximately 33 cc. In addition to these potential benefits, the EV-ICD approach is designed to prevent the rare, but potentially serious, risks that can occur when leads are implanted inside the vasculature and the heart.
The data presented at CARDIOSTIM 2016 assessed the feasibility of pacing and defibrillation with leads outside the heart and under the rib cage:
"Medtronic is continuously working to accelerate the development of meaningful innovations that improve patient outcomes," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Cardiac Rhythm and Heart Failure division. "These studies not only demonstrate the feasibility of this new approach, but also reinforce the broader sentiments from the physician community that innovation is needed for patients at risk of sudden cardiac death."
Sudden cardiac arrest is an abrupt loss of heart function that can result in death if not treated within minutes. Conventional ICDs involve leads (thin wires) connected to the heart to deliver shocks or ATP that restore normal heart rhythms. ICDs are proven to be 98 percent effective in treating dangerous ventricular arrhythmias that can lead to sudden cardiac arrest.1,2
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1Zipes, DP, Roberts, D. for the Pacemaker-Cardioverter-Defibrillator investigators. Results of the International Study of the Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59- 65.