Impulse Dynamics, a medical technology company, has successfully implanted the first device in the INTEGRA-D study for cardiac treatment. The study aims to evaluate the safety and effectiveness of the company’s Optimizer Smart System in patients with heart failure.
Heart failure is a condition where the heart is unable to pump enough blood to meet the body’s needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Current treatments for heart failure include medications, lifestyle changes, and implantable devices such as pacemakers and defibrillators.
The Optimizer Smart System is a unique device that delivers Cardiac Contractility Modulation (CCM) therapy to the heart. CCM is a non-invasive treatment that uses electrical impulses to improve the heart’s ability to contract and pump blood. The Optimizer Smart System is implanted under the skin and connected to leads that are placed on the heart’s surface.
The INTEGRA-D study will enroll up to 350 patients with heart failure who are not responding to current treatments. The study will evaluate the safety and effectiveness of the Optimizer Smart System compared to standard medical therapy. The primary endpoint of the study is a reduction in hospitalizations due to heart failure.
The first patient in the study was successfully implanted with the Optimizer Smart System at the University of California, San Diego. Dr. Barry Greenberg, the principal investigator of the study, said, “We are excited to be part of this important study evaluating a novel therapy for patients with heart failure who have limited options.”
Impulse Dynamics CEO, Simos Kedikoglou, said, “We are thrilled to have enrolled the first patient in the INTEGRA-D study and look forward to working with our clinical partners to advance this important research.”
The Optimizer Smart System has already been approved for use in Europe and other countries. The INTEGRA-D study is part of the company’s efforts to gain approval from the US Food and Drug Administration (FDA) for use in the United States.
In conclusion, the successful implantation of the first device in the INTEGRA-D study is a significant milestone for Impulse Dynamics and the treatment of heart failure. The study has the potential to provide a new treatment option for patients who are not responding to current therapies. The results of the study will be eagerly awaited by the medical community and patients alike.
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