The results included 12-month data from an analysis of 51 symptomatic heart failure patients with reduced ejection fraction and treated with the AccuCinch system
The AccuCinch system secured FDA breakthrough device designation in July last year. (Credit: Pexels from Pixabay)
Ancora Heart has announced that its investigational AccuCinch Ventricular Restoration System showed improvement in heart failure (HF) patient outcomes and beneficial changes in the heart structure as per an analysis.
The AccuCinch system intends to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant.
The data were presented at the Technology and Heart Failure Therapeutics conference (THT 2023) and published in the Journal of Cardiac Failure.
The results included 12-month data from an analysis of 51 symptomatic heart failure patients with reduced ejection fraction (HFrEF) and treated with the AccuCinch system.
US-based Ancora Heart, which develops transcatheter device-based therapy for heart failure, said that patients involved in the analysis matched key inclusion criteria of the currently enrolling CORCINCH-HF trial.
Ancora Heart president and CEO Jeff Closs said: “The AccuCinch System continues to demonstrate tremendous potential to fill a need in heart failure treatment options, and today’s analysis shows its ability to improve the health of the left ventricle in a safe and effective manner.
“We are excited about the significant and sustained results of this 12-month analysis and look forward to completion of the CORCINCH-HF pivotal trial and eventual submission to the FDA.”
The analysis’ primary outcome was the change of left ventricular end-diastolic volume (LVEDV) compared to baseline through 12 months.
As per the findings, the system showed significant and progressive improvement in LVEDV at 12 months compared to baseline. The results also included significant and sustained improvement in overall quality of life scores compared to baseline.
Additionally, the device demonstrated significant and sustained improvement in functional capacity, New York Heart Association (NYHA) classification, and ejection fraction (EF) at 12 months compared to baseline.
The US-based company said that the flexible implant is attached to the inner wall of the left ventricle and cinched during the minimally invasive AccuCinch system procedure.
The device is designed to minimise the size of the left ventricle, reduce ventricular wall stress, and aid and strengthen the heart wall.
In July last year, the AccuCinch system secured the breakthrough device designation from the US Food and Drug Administration (FDA).