Electroducer Shares Positive Results From Pilot Sleeve Study

Electroducer is touting positive results from a pilot study of its Electroducer Sleeve.  

The study involved 60 patients from four French medical centers (the Clinique Pasteur in Toulouse, the Cardiovascular Institute in Grenoble, the Médipôle Lyon-Villeurbanne Hospital in Villeurbanne and the Jacques Cartier private Hospital in Massy). It was the first of its kind in the world and confirmed that the Electroducer Sleeve is a safe and effective treatment for heart valve diseases and complex coronary interventions. 

“As well as offering benefits for patients, this device is simple and universal—these advantages mean there will certainly be widespread uptake and usage,” said Dr. Jérôme Wintzer-Wekehind, principal study investigator and interventional cardiologist at the Cardiovascular Institute in Grenoble.

The Electroducer Sleeve makes it simpler and safer to perform endovascular procedures requiring temporary cardiac pacing. Implanting a temporary pacemaker is the current conventional technique. This is an invasive procedure that carries additional risks and increases procedural time and radiation exposure for the patient. In the future, the Electroducer Sleeve could replace this step by enabling 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 at the same time. According to a study published in 2019,¹ it also reduces the total cost of the procedure by around 12%.   

“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,” stated Dr. Nicolas Dumonteil, a study investigator and interventional cardiologist at the Clinique Pasteur in Toulouse. 

The Electroducer Sleeve is expected to reach the U.S. market in 2023, and the European market next year upon U.S. Food and Drug Administration authorization and CE marking, respectively. The device has the potential to be used in nearly 1.5 million interventions per year worldwide by 2025. The company aims to capture 8% of this market, representing around 120,000 procedures per year, by this date.

“Having our study results published in such a prestigious medical journal shows that our clinical approach has tremendous potential to become the procedure of choice. It is a great opportunity to present the benefits of our solution to the global cardiology community. We plan to bring the Electroducer Sleeve® to market within the next year, so that as many patients and cardiologists as possible can take advantage of our technology,” Electroducer Founder/CEO Dr. Benjamin Faurie said.

Founded in 2018, Electroducer designed and developed the Electroducer Sleeve, specifically to treat heart malfunctions requiring a valve replacement, or percutaneous coronary interventions. The device is based on a medical technique known as Direct Wire Pacing (DWP), which was also developed by the company’s founder and used for the first time in 2011. The technique uses the guidewire—the instrument used to deliver the replacement valve—to directly stimulate the heart muscle, eliminating the need for a temporary pacemaker and all the associated complications, which in 2%–6% of cases can be serious. It has proven to be simpler, faster and cheaper than the conventional technique, with less radiation, and as effective.

Direct Wire Pacing (DWP) is a technique for Transcatheter Aortic Valve Implantation (TAVI) with proven advantages over the conventional approach, as confirmed by the randomized multi-center EASY TAVI study (JACC 2019¹). In the case of TAVI, DWP helps limit per- and post-operative trauma by significantly reducing the duration and the invasive nature of the procedure. For physicians, the technique simplifies the procedure and makes it safer, without any need to change their existing practices. For hospitals, meanwhile, it represents a real cost saving of around 12% compared to the conventional approach. However, Direct Wire Pacing has some technical limitations that hinder widespread adoption. The Electroducer Sleeve aims to increase the number of patients with access to this revolutionary technique by providing a universal, easy-to-use, turnkey device.

Research and development work is also underway, looking into some other highly promising applications around neuromodulation and the non-pharmacological treatment of hypertension.

Electroducer is based in Grenoble, France, and is supported financially by public sector financing bodies (French public investment bank Bpifrance, the Auvergne-Rhône-Alpes regional authority and the French Ministry of Higher Education, Research and Innovation) and private investors.

Reference
¹ Benjamin Faurie, Géraud Souteyrand, Patrick Staat, Matthieu Godin, Christophe Caussin, Eric Van Belle, Lionel Mangin, Pierre Meyer, Nicolas Dumonteil, Mohamed Abdellaoui, Jacques Monségu, Isabelle Durand-Zaleski, Thierry Lefèvre and for the EASY TAVI Investigators. Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement, Journal of American College of Cardiology (JACC), Volume 12, Issue 24 (2449-2459), December 2019.