The device, manufactured by Boston Scientific, combines the technology of leadless pacemakers with subcutaneous implantable cardioverter defibrillators. Unlike traditional pacemaker-ICD’s, the leadless system does not require wires to be threaded throughout blood vessels.
“Combined use of both types of devices in a leadless approach could benefit a much larger patient population,” said Daniel Cantillon, MD, research director and associate section head of Cardiac Electrophysiology and Pacing in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and global principal investigator.
“Furthermore, while life-saving, ICD shocks are both painful and psychologically traumatizing for patients. 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.”
The Boston Scientific-sponsored trial will enroll up to 300 patients across 50 centers in the U.S., Canada and Europe, including patients who require a new ICD or who already have a subcutaneous-ICD system implanted.
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