Medical device company Impulse Dynamics has concluded the first implantation for the INTEGRA-D multicentre clinical study.
The procedure was conducted at Cleveland Clinic and represents the first-in-the-world implantation of the company’s dual cardiac device.
The trial is intended to assess the safety and efficacy of the Optimiser Integra CCM-D System, which combines two cardiac therapies: cardiac contractility modulation (CCM) and an implantable cardioverter defibrillator (ICD).
The system improves the quality of life and reduces symptoms of heart failure by improving heart contraction through CCM therapy. It also delivers ICD therapy for the treatment of life-threatening arrhythmias that may lead to sudden cardiac death.
INTEGRA-D clinical trial national primary investigator and Cleveland Clinic electrophysiologist Dr Niraj Varma said: “The trial aims to study whether this device can protect heart failure patients from the risk of sudden cardiac death while also treating heart failure symptoms.”
The study’s objective is to evaluate the effectiveness of the CCM-D device in treating ventricular tachycardia and ventricular fibrillation episodes, along with providing CCM treatment for heart failure.
It involves 300 subjects from 75 centres across the US. Study participants will be implanted with the Optimiser Integra CCM-D System and monitored for a minimum of two years.
The rechargeable investigational implant technology comes with long battery life, potentially reducing the need for replacement procedures.
Impulse Dynamics CEO Dr Simos Kedikoglou said: “We are proud to partner with physicians at leading centres around the world to conduct important research on this first-of-its-kind rechargeable combination device designed to address a major unmet need of a large patient group.”