Impulse Dynamics Completes First Implant For CCM-D Clinical Trial

KUALA LUMPUR, May 19 (Bernama) -- Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure, announced the completion of the first implantation for the INTEGRA-D clinical trial.

It is designed to evaluate the safety and efficacy of two proven cardiac therapies combined — cardiac contractility modulation (CCM) and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D).

The Optimizer Integra 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.

According to Impulse Dynamics in a statement, the investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

“Today’s announcement is another example of our commitment to a continuous pace of innovation to build a comprehensive platform in interventional heart failure and help improve the lives of many patients that suffer from this debilitating disease.

“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,” said Impulse Dynamics Chief Executive Officer, Simos Kedikoglou.

The INTEGRA-D trial is a multicentre study of 300 subjects from 75 centres that will evaluate the combination of CCM and ICD therapy in a single device via the Optimizer Integra CCM-D System.

The study will assess the performance of the CCM-D device in effectively treating episodes of ventricular tachycardia and/or ventricular fibrillation while also providing CCM treatment for heart failure. Patients enrolled in the study will receive the Optimizer Integra CCM-D System, and will be followed for at least two years.

The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. The study device is currently being tested and is not approved by the United States (US) Food and Drug Administration (FDA).

Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked which delivers CCM therapy, designed by the company to significantly improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body.

-- BERNAMA