CLEVELAND — The Cleveland Clinic says they have “successfully implanted a dual cardiac device in the first patient in the world as part of a clinical trial, which aims to potentially treat heart failure symptoms.”
Details were announced Thursday morning as Cleveland Clinic officials said this INTEGRA-D clinical study will be used to evaluate the safety and effectiveness of a device that combines two proven cardiac therapies into one.
“Cardiac contractility modulation works to improve the contraction of the heart, while an implantable cardioverter defibrillator treats life-threatening arrhythmias that cause sudden cardiac death,” according to a Cleveland Clinic press release.
The Cleveland Clinic says the Centers for Disease Control and Prevention reports heart failure impacts an estimated 6.2 million Americans.
Editor's note: Video in the player above was originally published in an unrelated health story on May 12, 2023.
“Most heart failure patients are prescribed medications that work to slow the disease’s progression and manage symptoms, but effectiveness can wane over time,” according to the Cleveland Clinic. “While standard, existing implantable cardiovascular defibrillators are lifesaving, the technology alone does not improve the debilitating symptoms of heart failure.”
The clinical trial, sponsored by Impulse Dynamics, manufacturer of the device, will enroll 300 patients from 75 centers across the U.S. who will be followed for two years.
“This could be an important advancement for heart failure patients, requiring just one procedure to deliver two important therapies and prevent sudden cardiac death,” said Bruce Wilkoff, M.D., director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic and principal investigator for the INTEGRA-D study. “The hope is that this rechargeable technology --with a potential battery life of up to 20 years --will significantly reduce the need for replacement procedures.”
Editor's note: Video in the player above was originally published in an unrelated health story on Feb. 14, 2023.
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