Boston Scientific initiates trial to evaluate leadless pacemaker

MedTech News: Boston Scientific initiated a clinical trial to evaluate its leadless pacemaker therapy system.

The company has 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 the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).

There is competition in the leadless pacemaker space with Abbott 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 the largest evaluation of leadless pacemakers to date. Micra is one-tenth the size of previous pacemakers on the market, the company said.

“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,” said Dr Kenneth Stein, senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. “The components of the system are designed to work in concert with each other, regardless of when implanted, giving physicians the ability to provide personalised patient care today while keeping options open in the future.”

The prospective, non-randomised MODULAR ATP clinical trial will enrol at up to 50 centres in the U.S., Canada and Europe up to 300 patients who are guideline-indicated for an ICD or who already have an Emblem or Emblem MRI S-ICD System implanted. The trial will evaluate the system- and procedure-related complication-free rate of the Empower MPS, the communication success between the Empower MPS and the S-ICD System and adequate pacing capture thresholds of the Empower MPS.

Preclinical data presented as late-breaking basic science at American Heart Association Scientific Sessions 2021 demonstrated that the mCRM System had good performance at up to 18 months, as defined by stable communication between devices, and ability to deliver therapy as intended.