Boston Scientific wants to stand out in the world of leadless pacemakers. The Marlborough, MA-based company said it has initiated the MODULAR ATP clinical trial to evaluate the performance and effectiveness of the mCRM modular therapy system.
The system consists of two cardiac rhythm management (CRM) devices that are intended to work together to coordinate therapy: the EMBLEM MRI System for Subcutaneous Implantable Defibrillators (S-ICD) and the EMPOWER Modular Stimulation System (MPS), which is designed to as the first leadless pacemaker to provide both bradycardia pacing and anti-tachycardia pacing (ATP) support.
“The S-ICD System, which we acquired from Cameron Health, was CE marked in 2009 and approved by the FDA in 2012,” Kenneth Stein, MD, FACC, senior vice president and chief medical officer of FHRS, Rhythm Management and Global Health Policy, Boston Scientific told MD+DI. “The current-generation EMBLEM MRI S-ICD System – one of the devices in this trial – received CE marking and FDA approval in 2016. It is a proven treatment option for the prevention of sudden cardiac death and the only commercially available ICD system that leaves the vascular system untouched.”
Stein added: “The EMPOWER MPS we developed is a research device and is not commercially available anywhere in the world. It consists of a leadless pacemaker and a delivery catheter and is designed to be the first leadless pacemaker to provide support for bradycardia pacing as well as anti-tachycardia pacing (ATP). The EMPOWER MPS is designed to work with the S-ICD System and maintain its benefits, while providing an option for patients requiring stimulation in the future. It is also designed to provide stand-alone bradycardia pacing therapy.”
The MODULAR ATP prospective, non-randomized clinical trial will enroll at up to 50 centers in the US, Canada and Europe for up to 300 patients who are guidelines indicated for an ICD or who already have an EMBLEM or EMBLEM MRI S-ICD System have implanted. The trial evaluates the system- and procedure-related complication-free percentage of the EMPOWER MPS, the communication success between the EMPOWER MPS and the S-ICD System, and adequate pacing thresholds of the EMPOWER MPS.
“This study is important because patients who may benefit from receiving an S-ICD System often have a TV-ICD implanted due to the possibility that there will be a need for bradycardia pacing or ATP in the future — a therapy designed to of fast, abnormal heartbeats,” Stein said. “Since the EMPOWER MPS device can be delivered percutaneously through a minimally invasive approach without the use of leads, the mCRM System could retain many of the benefits of the S-ICD System, while providing an option for patients who subsequently develop a stimulation requirement. By bringing an ATP option to those who need it, we hope the EMPOWER MPS can expand the patient population that could benefit from S-ICD therapy.”
The pilot starts at an interesting time for the CRM space.
Last month, favorable data from a global study evaluating Abbott’s Aveir leadless pacemaker was published in the Journal of the American College of Cardiology: Clinical Electrophysiology, and Abbott said the data has also been submitted to the FDA in support of approval.
Medtronic has the honor of having the first leadless pacemaker on the US market. The Dublin-based company received FDA approval for Micra about five years ago.
Stein pointed out how Boston Sci’s technology stands out.
“Like the Medtronic Micra and Abbott Aveir devices, the EMPOWER MPS can function as a standalone pacemaker for patients who only need treatment for bradycardia,” Stein said. “Neither the Micra nor the Aveir are designed to interface with an independent S-ICD system to deliver ATP, the way the EMPOWER MPS is designed.”