Electroducer Sleeve for Direct-Wire Pacing During Cardiac Interventions Evaluated in Pilot Study

December 15, 2022—Electroducer, which is a Grenoble, France-based medical device developer focused on the treatment of heart diseases, announced the results from the pilot study of the company’s Electroducer Sleeve for use in endovascular procedures requiring temporary cardiac pacing.

According to the company, the Electroducer Sleeve, a direct-wire pacing (DWP) device, enables the heart to be stimulated directly through the guidewire, which is used to deliver the valve or stent. This combined approach simplifies the procedure and reduces the risk of complications versus the current conventional technique of using a temporary pacemaker.

Jérôme Wintzer-Wehekind, MD, et al published the findings online ahead of print in EuroIntervention.

According to the company, the study confirmed that the Electroducer Sleeve is a safe and effective treatment for heart valve diseases and complex coronary interventions. The study involved 60 patients from four medical centers in France: Clinique Pasteur in Toulouse; the Cardiovascular Institute in Grenoble; the Médipôle Lyon-Villeurbanne Hospital in Villeurbanne; and the Jacques Cartier Private Hospital in Massy.

Dr. Wintzer-Wekehind, who is an interventional cardiologist at the Cardiovascular Institute in Grenoble and served as Principal Investigator of the study, commented in the company’s press release, “As well as offering benefits for patients, this device is simple and universal—these advantages mean there will certainly be widespread uptake and usage.”

Study investigator Nicolas Dumonteil, MD, an interventional cardiologist at the Clinique Pasteur in Toulouse, added, “I am confident that in a few years’ time, Electroducer Sleeve will replace our conventional technique, providing physicians and patients with a faster, safer, and simpler procedure.”

The DWP technique, which was used for the first time in 2011, was developed by the interventional cardiologist Benjamin Faurie, MD, who is CEO and Founder of Electroducer.

The company stated that DWP previously showed it limited peri- and postoperative trauma by significantly reducing the duration and the invasive nature of the procedure and demonstrated a reduction of the total cost of the procedure by approximately 12%. That study, “Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement,” was published in 2019 by Dr. Faurie et al in Journal of American College of Cardiology (2019;12:2449-2459).

The Electroducer Sleeve is expected to be commercially available in the United States in 2023 and in Europe in 2024 after receiving the respective regulatory approvals. Initially, the device will be used for transcatheter aortic valve replacement and complex coronary procedures. By 2025, the technology will also be used in mitral and tricuspid valves replacement, advised Electroducer.