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Bos Sci’s Leadless Pacer Proves Feasibility


Posted in Implantable Devices by mthibault on May 15, 2017

Researchers have shown that the company’s in-development leadless pacemaker successfully delivers anti-tachycardia pacing and works in tandem with the subcutaneous ICD. What’s next for the technology?


Marie Thibault

Boston Scientific's in-development Empower leadless pacemaker.

Data from an animal study of Boston Scientific’s in-development Empower leadless pacemaker showed that the device delivers appropriate pacing therapy and receives communication from the S-ICD subcutaneous ICD. Those findings, presented late last week during the Heart Rhythm Society’s annual meeting in Chicago and published in the Journal of the American College of Cardiology: Clinical Electrophysiology, proved the feasibility of the leadless pacemaker design and modular system.

Kenneth Stein, MD, FACC, senior vice president and chief medical officer of Global Health Policy and Rhythm Management at Boston Scientific, previously told MD+DI that the Empower leadless pacemaker would be a “broader concept of what a leadless pacemaker is and can be.” The device is designed as a modular component that can be used alone or in coordination with the company’s S-ICD. 

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Fleur V.Y Tjong, MD, of the Academic Medical Center in Amsterdam, presented the findings at HRS. She told MD+DI that this proof-of-concept study involved testing the leadless pacemaker and S-ICD in ovine, porcine, and canine animal models. Of the 40 animals in the study, 39 were successfully implanted with the devices and 23 were followed out to 90 days after implantation. Key objectives included studying the intrabody communication between the S-ICD and the leadless pacemaker, as well as the delivery of anti-tachycardia pacing therapy.

Communication between the S-ICD and the leadless pacemaker was successful in 99% of the 401 attempts and anti-tachycardia pacing was delivered 100% of the time the communication was received.

“We found that both the acute and chronic performance of the leadless pacemaker was very satisfactory,” Tjong said.

Tjong explained that these success rates are “especially reassuring considering that in these animals the device orientations, for example, were somewhat challenging . . . because the animal anatomy is much smaller and the pacemakers were placed almost vertically.” When implanted in humans, these devices should be positioned more favorably, she added. 

Of course, the leadless pacemaker still needs to be studied in human clinical trials for safety and effectiveness. While the modular system of leadless pacemaker and S-ICD together could be an option for patients who need ICD therapy and have a bradycardia indication, Tjong noted that the system doesn’t offer dual-chamber pacing therapy or cardiac resynchronization therapy (CRT).

In addition, the system currently allows the S-ICD to communicate with the leadless pacemaker, but doesn’t offer communication from the pacemaker to the S-ICD. “One could envision that when there is bi-directional communication, feedback from the pacemaker back to the S-ICD, that could help to further optimize S-ICD therapy and decrease inappropriate shocks on double counting or T-wave oversensing,” Tjong said.

Tjong, who is experienced in implanting leadless pacemakers from St. Jude Medical (Nanostim) and Medtronic (Micra), pointed to two other novel features of the Boston Scientific device: the telescope capability of the system’s delivery catheter and the retrieval catheter. The telescope capability allows the operator to move and steer the pacemaker without too much force while the dedicated retrieval catheter is intended to help remove the device after battery depletion.  

Looking into the technology’s future, Tjong concluded, “It’s going to be a challenge overall for leadless pacemakers . . . the retrievability of the devices when the battery is depleted.” She added, “The Boston device that is being developed, it has a dedicated retrieval catheter. I think that is something that really is important to allow for safe retrieval of these devices after several years of implantation.”

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com on Twitter @MedTechMarie.

[Image courtesy of BOSTON SCIENTIFIC]


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