CardioKinetix made strides in research for its novel Parachute catheter-based left ventricle implant, which proved promising after 2 years in study results unveiled at this year’s EuroPCR conference in Paris.
The Parachute is inserted into the heart via a catheter threaded through the femoral artery. Once inside the heart, the device springs open and attaches to the walls of the heart to provide support for patients whose left ventricle was left enlarged after a heart attack.
The device aims to partition the damaged muscle from the healthy, functional parts of the heart in order to decrease the burden on the ventricle.
The pair of 1st-in-human studies showed that patients with the Parachute implant after 2 years generally improved their heart failure score by an entire class, as graded on the New York Heart Assn. rating system.
"It is difficult to contain our enthusiasm because the procedure is relatively simple and the outcomes are surprisingly remarkable for such a high-risk population," investigator Dr. Marco Costa said in prepared remarks. "If these results are confirmed in the upcoming large randomized trial, the Parachute implant will revolutionize the treatment of patients with ischemic dilated cardiomyopathy."
The study involved 31 patients treated in the U.S. and Europe over 2 years, during which time the rate of cardiac death was 6.5%, and all-cause mortality was 32.3%. Those figures "compare favorably" with current medical therapy, according to a press release.
The data supports the design for a larger, randomized pivotal trial that will in turn support a bid for FDA approval.
"We are extremely pleased with the 2-year clinical results from the Parachute implant," investigator Dr. William Abraham said in prepared remarks. "This innovative device has the potential to bring together two cardiology disciplines – heart failure and interventional cardiology – to address a significant unmet need in heart failure.