Boston Scientific launches trial of modular, leadless pacemaker-defibrillator system

Boston Scientific has begun a clinical trial of its first modular cardiac rhythm implant system. It consists of a leadless pacemaker and an implantable cardioverter defibrillator—two separate devices that aim to work together to keep the heart from beating too fast or too slow.

The study’s first two patients underwent the procedure at the Cleveland Clinic. The implants communicate wirelessly and require no electric leads to be threaded into the heart muscle. Wires can fracture over time and have been associated with a risk of blood clots.

“The components of the system are designed to work in concert with each other, regardless of when implanted, giving physicians the ability to provide personalized patient care today while keeping options open in the future," Kenneth Stein, M.D., Boston Scientific’s chief medical officer for heart rhythm management, said in a statement.

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In total, the trial aims to enroll up to 300 participants from as many as 50 medical centers in the U.S., Canada and Europe, including those who may need an implantable cardioverter defibrillator and those who may already have a compatible system implanted.

Implantable cardioverter defibrillators, or ICDs, have been implanted in more than 100,000 patients nationwide, according to Boston Scientific, and are effective at delivering an electric shock to the heart after detecting sudden cardiac arrest due to the rapid beating caused by ventricular tachycardia.

The medtech manufacturer now hopes to add protection against abnormally slow heartbeats and flatlining scenarios by pairing its Emblem implantable defibrillator with its Empower leadless pacemaker, with the latter currently under development. And while typical ICDs thread leads through veins into the heart, Emblem's subcutaneous system places electrodes between the skin and the rib cage.

“Modular therapy curates implantable medical device therapy to the specific needs of patients throughout their lifetime so that they receive only the device they need when they need it,” said the study’s co-principal investigator, Daniel Cantillon, a research director at the Cleveland Clinic’s Heart, Vascular & Thoracic Institute. 

Boston Scientific's Emblem MRI implantable defibrillator and its
investigational Empower leadless pacemaker (Boston Scientific)

“Furthermore, while life-saving, ICD shocks are both painful and psychologically traumatizing for patients,” Cantillion added. “It’s our hope that the combination of a tiny leadless pacemaker implanted directly into the heart with the subcutaneous-ICD in the soft tissue will allow the majority of lethal arrhythmias to be painlessly terminated without long-term risks.”

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The number of players in the leadless pacemaker market could expand in the near future, with Abbott’s retrievable system in FDA review. The Aveir system is designed to provide ventricular pacing on-demand, triggering electrical pulses only when needed to get a slowing heart back on track, instead of providing a constant cadence.

The minimally invasive device is also designed to be more easily removable by a surgeon when the battery needs to be replaced or if a patient’s therapy regimen needs to be updated.

And earlier this year, Medtronic presented a study showing that its miniaturized leadless pacemakers improved long-term safety compared to larger, wired versions. Medtronic's leadless pacemakers, first approved in 2016, are about one-tenth the size of traditional devices and are implanted within the interior wall of the heart itself.  

However, more recently, the FDA looked to remind healthcare providers of the potential risks inherent in leadless pacemakers’ implantation procedures, which in rare cases can cause heart perforations. While wired pacemaker leads carry the same risk, when caused by a leadless device the complications tend to be more severe, the agency said in a November notice.