Medtronic initiates pilot study for the Extravascular Implantable Cardioverter Defibrillator .
Medtronic plc has announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and antitachycardia pacing therapy all in one system, with a device size similar to transvenous ICDs. The first patient implant was performed at Christchurch Hospital in New Zealand, representing the first intended long-term patient use of the Medtronic EV ICD system.
The EV ICD system is investigational and not approved for sale or distribution."The Medtronic EV ICD system has the potential to deliver the benefits of traditional ICDs while eliminating the risks that can occur when leads are implanted inside the veins and heart," said Ian Crozier, M.D., Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand, and principal investigator (PI) in the Medtronic Extravascular ICD Pilot Study. "We are incredibly pleased to contribute to this important research that will serve as a key step in establishing the safety and efficacy of this new approach."
The pilot study will assess the Medtronic EV ICD system in 20 patients at four sites: Christchurch Hospital (Dr. Crozier); Austin Health in Heidelberg, Australia (PI: David O'Donnell, M.D.); MonashHeart in Clayton, Australia (PI: Emily Kotschet, M.D.); and The Prince Charles Hospital in Brisbane, Australia (PI: Haris Haqqani, M.D.). After implantation of the system, patients and their devices will be routinely checked to assess safety and device performance. Medtronic research teams developed the EV ICD System and have completed multiple early research and acute feasibility studies using the system components, including the ASD1 (Acute Sensing and Defibrillation), SPACE2 (Substernal Pacing Acute Clinical Evaluation) and ASD23 studies.
Comment:The Extravascular Implantable Cardioverter Defibrillator (EV ICD) system can deliver defibrillation shocks as well as pacing signals to the heart, but it uses only a single lead placed under the sternum outside the heart.
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