Marlborough, Massachusetts-based Boston Scientific designed the mCRM system with two cardiac rhythm management (CRM) devices intended to work together and communicate wirelessly to coordinate therapy.
The Emblem MRI subcutaneous implantable defibrillator (S-ICD) system and the Empower modular pacing system (MPS) combine to offer what Boston Scientific touts as the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP), according to a news release.
Competition in the leadless pacemaker space is heating up, with Abbott just last month reporting that its Aveir leadless pacemaker could offer new benefits in treating slow heart rhythms. Both Boston Scientific’s mCRM and Abbott’s Aveir battle Medtronic’s Micra, which earlier this year demonstrated positive outcomes in what the company said was the largest evaluation of leadless pacemakers to date. Micra is one-tenth the size of previous pacemakers on the market, the company has said.
Boston Scientific’s S-ICD system offers protection without touching the heart or substernal space to prevent sudden cardiac death. The Empower MPS complements the S-ICD system as a modular option for patients who develop ATP needs in the future, the company said.
The prospective, non-randomized Modular ATP clinical trial will enroll up to 300 patients at up to 50 centers in the U.S., Canada and Europe. The patients enrolled will be guideline-indicated for an ICD or already have an Emblem or Emblem MRI S-ICD system implanted.
The Cleveland Clinic announced the first implantations today.
“Combined use of both types of devices in a leadless approach could benefit a much larger patient population,” said Cleveland Clinic’s Dr. Cantillon, a principal investigator in the study.
“Furthermore, while life-saving, ICD shocks are both painful and psychologically traumatizing for patients,” Cantillon said. “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.”
Boston Scientific’s trial will evaluate the system- and procedure-related complication-free rate of Empower MPS, the communication success between the Empower MPS and the S-ICD system and adequate pacing capture thresholds of Empower MPS.
“Since the Empower MPS device can be delivered percutaneously via a minimally invasive approach without the use of leads, the mCRM System could preserve many of the benefits of the S-ICD System while offering an option for patients who subsequently develop a pacing requirement,” Boston Scientific SVP & CMO for Rhythm Management & Global Health Policy Dr. Kenneth Stein said in the release. “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.”