Ancora Heart has unveiled encouraging initial safety data from its recently expanded early feasibility study of its investigational AccuCinch Ventricular Repair System designed for treating heart failure and functional mitral regurgitation (FMR).
Image: Ancora Heart shows positive interim analysis in new study. Photo: Courtesy of dream designs/FreeDigitalPhotos.net.
Ancora Heart presented the data at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
The company claims that the transcatheter AccuCinch therapy has the potential for treating heart failure and FMR, in patients where the disease has advanced beyond the management of medications and pacemakers or for whom the risks of open-heart surgery are too high.
Unlike the current technologies which replicate surgical procedures to replace or repair an otherwise-normal mitral valve, the AccuCinch system is claimed to repair the left ventricle of the heart directly, to address the fundamental issue in the progression of systolic heart failure.
The interim analysis from the first group of 16 patients with heart failure and FMR was presented in two sessions at the meeting by Dan Burkhoff at Cardiovascular Research Foundation (CRF) and separately by University of Washington Medical Center, medicine clinical professor, interventional cardiology section head and cardiovascular emerging therapies director, Mark Reisman.
Ancora Heart president and CEO Jeff Closs said: “These preliminary efficacy data suggest that repairing the enlarged left ventricle with the AccuCinch system may not only reduce mitral regurgitation but may also improve heart function. The results are highly encouraging, and we look forward to continuing to study the device’s many potential benefits in this study and future studies.
“Our goal is to show that a therapy focused on the ventricle will make a real difference in both quality and length of life for heart failure patients.”
The initial data from the study has shown a favorable safety profile with consistent procedural safety at 30 days, with no major adverse cardiac events and no-device-related deaths.
Preliminary efficacy data has also shown that a 30-day follow-up demonstrated, reduction in left ventricular volume by about 29%. Ejection fraction (EF), a measure of blood flowing out of the left ventricle, improved on average from 30% to 42%.
Furthermore, mitral regurgitation grades and regurgitant volumes were both substantially reduced across this cohort.