Boston Scientific's modular, wireless heart rhythm implant approach clears clinical study

A six-month trial showed that Boston Scientific’s pairing of modular, wireless implants for managing discordant cardiac rhythms—and correcting dangerous ones—could be a successful approach, and the devicemaker has its heart set on an FDA approval for the system in 2025.

The company linked its leadless Empower pacemaker with its Emblem subcutaneous implanted defibrillator. The approach allows one device to keep the heart from beating too fast or too slow, while the other stands by to deliver a shock to interrupt potentially fatal arrhythmias.

The Emblem’s design aims to avoid some of the long-term complications seen with traditional implantable cardioverter defibrillators (ICDs) that have generators wired into the heart through the veins, such as infections; its less invasive route places leads under the skin but outside the rib cage. However, that prevents the device from also addressing bradycardia and tachycardia with direct pacing support. 

That’s where Empower comes in. The leadless pacemaker, currently under development, is embedded inside the heart’s chambers to painlessly help get its beat back on track. The two devices communicate with each other wirelessly to sense abnormal rhythms, trigger the appropriate therapy and monitor the result.

According to the pivotal study’s results—which were presented at the Heart Rhythm Society’s annual meeting and published in The New England Journal of Medicine—communication tests showed a success rate of 98.8%, and 97.5% of the trial’s 162 evaluated patients saw no major leadless pacemaker complications during implantation or after half a year.

Boston Scientific Empower Emblem
The Emblem S-ICD and Empower leadless pacemaker ((Boston Scientific))

In addition, 61.3% of arrhythmia episodes were successfully stopped by antitachycardia pacing, with no cases in the remaining 38.7% being attributed to communication failure.

“It is the first system in which medical devices, which are implanted separately in the body, are in contact with each other and work together,” said study leader Reinoud Knops, M.D., Ph.D., a professor of cardiology at Amsterdam UMC. “Its development will reduce the number of complications and invasive procedures all while maintaining patient safety.”

“These findings are noteworthy, as high percentages of communication success and pain-free termination of spontaneous arrhythmia episodes indicate a potential upgrade pathway for patients currently implanted with [a subcutaneous ICD] who develop a need for [anti-tachycardia] or pacing,” said Knops. 

According to Boston Scientific, all Emblem devices, with more than 130,000 already implanted worldwide, could be paired in the future with a newly placed Empower pacemaker. The company estimates that about 75% of ICD patients do not require pacing support at the time of their first implant procedure, while about 2% develop the need for it annually.

“Instead of subjecting all patients to the risks of more invasive approaches, such as placing leads in the heart or tunneling them under the sternum to provide therapies they might not require, these data indicate physicians may have the opportunity to tailor therapy to the patient's individual needs and health,” Boston Scientific’s global chief medical officer, Kenneth Stein, M.D., said in a statement.