Medical technology firm BioControl Medical has completed the enrollment of patients in its Increase Of Vagal Tone in Heart Failure (INOVATE-HF) clinical trial, which has been designed to assess the CardioFit system to treat congestive heart failure (HF).
Designed for cardiac use, the CardioFit system includes a stimulator sensor lead and stimulation lead that are implanted under the skin of the chest.
The company has enrolled around 725 patients in the trial at 86 centers in the US and Europe, which is the prospective and randomized device study to evaluate the treatment of HF with vagus nerve stimulation.
BioControl Medical CEO Dr Ehud Cohen said: "I want to sincerely thank each and every trial site and patient participating in INOVATE-HF for their role in getting us to this important milestone."
The trial, which was launched in April 2011, is an investigational device exemption (IDE) clinical study to determine the safety and efficacy of CardioFit in reducing hospitalization and death among patients with HF by comparing treatment with CardioFit to standard evidence-based management.
The primary endpoint of the trial is to compare the number of HF hospitalizations and all-cause mortality in patients with CardioFit versus those on standard evidence-based management.
BioControl plans to present the study results by the end of 2016, which will be used to support a premarket approval application to the US Food and Drug Administration.