Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced on May 18, 2023 the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.
According to the press announcement:
CCM therapy delivered by the Optimizer System improves quality of life and helps patients feel better. Patients indicated for CCM therapy may also be at a higher risk for arrythmias and sudden cardiac arrest and are therefore often offered an ICD to treat their heart for life-threatening arrythmias, should they occur. The INTEGRA-D trial is the first to evaluate the Optimizer Integra CCM-D System that combines both therapies into a single device, designed to last for many years.
“The first-in-the-world implant of this novel technology has potential to advance treatments for patients living with heart failure,” said Niraj Varma, M.D., Ph.D., electrophysiologist at Cleveland Clinic and National Primary Investigator of the INTEGRA-D clinical trial. “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.”
“We hope combining cardiac contractility modulation therapy and ICD therapy with prolonged battery life will reduce the number of leads and the number of procedures a patient may have to endure,” said Bruce Wilkoff, M.D., Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and Principal Investigator of the INTEGRA-D trial. “The first implant went well, and we look forward to further studying this device.”