News | Leads Implantable Devices | May 24, 2018

Medtronic Study Confirms Feasibility of New Extravascular Approach to ICD Therapy

Late-breaking presentation at Heart Rhythm 2018 highlights investigational experience with ICD lead placed under sternum, outside the heart and veins

Medtronic Study Confirms Feasibility of New Extravascular Approach to ICD Therapy

May 24, 2018 - Medtronic plc announced results from a research study demonstrating the feasibility of a novel approach to delivering pacing and defibrillation therapy in which a lead is placed under the sternum (breastbone), outside of the heart and veins. Data from the Acute Extravascular Defibrillation, Pacing and Electrogram (ASD2) study were presented during a late-breaking session at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions, May 9-12 in Boston.

The results of the international ASD2 feasibility study, an important step in the Medtronic extravascular implantable cardioverter defibrillator (EV ICD) clinical development program, confirmed that an investigational extravascular ICD lead can sense, pace and defibrillate the heart. This offers a potential future alternative to traditional transvenous ICD systems.

"Clinicians are highly interested in the potential for an extravascular ICD solution to provide both pacing and lifesaving defibrillation therapy without leads placed inside the heart or vasculature," said Lucas V.A. Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Department of Cardiology, Nieuwegein, the Netherlands and professor of cardiology, Academic Medical Center (AMC), University of Amsterdam, the Netherlands. "The ASD2 study offers very encouraging clinical insights, which bring us closer to implanting the first chronic investigational system in ambulatory patients."

The Medtronic EV-ICD System, which currently is in development and not available for use or sale, is a new approach to implantable defibrillation therapy that may offer the benefits of current transvenous defibrillators. In addition, the system may address current limitations of subcutaneous implantable defibrillators, including their inability to provide painless bradycardia pacing or antitachycardia pacing (ATP), and their larger size.

In ASD2, 79 patients who were already scheduled for elective cardiac surgery or a subcutaneous or transvenous ICD implant had an investigational EV-ICD lead inserted temporarily under the sternum and evaluated in conjunction with either a defibrillation patch or a defibrillator emulator. The ICD lead was designed to sense activity in the ventricles (lower chambers of the heart), provide pacing to the ventricles, and deliver a 30-joule defibrillation shock after ventricular fibrillation (VF) was induced.

Ventricular pacing was successful in 97 percent of patients, and shocks successfully terminated 83 percent of episodes, consistent with prior clinical studies of existing ICDs.1

Seven adverse events were reported in six of the 79 studied patients. As with any feasibility research evaluating a new procedure, the investigational procedure and lead implantation tools were refined during the study, with further technique training and education provided to all investigators in an effort to reduce the adverse event rate in future patients.

For more information: www.medtronic.com

Read more about HRS 2018 late-breaking clinical trials

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp