The US Food and Drug Administration (FDA) has granted approval to BioControl Medical to initiate the second phase of its increase of vagal tone in heart failure (INOVATE-HF) study, designed to assess the CardioFit electrical stimulation device as a treatment for congestive heart failure (HF).
CardioFit, which comprises of a stimulator, a sensor lead and a stimulation lead, is designed to alleviate HF symptoms, reverse HF deterioration and activate the parasympathetic nervous system directly to reduce stress on the heart.
The approval is based on the positive results of a controlled, prospective, randomised, initial phase study of 50 patients, which began in April 2011.
The second phase study will enrol patients at US centres to demonstrate the safety and efficacy of the CardioFit device as well as the system's potential to reduce hospitalisation and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
Gregory Ewald, INOVATE-HF study principal investigator, said the company has been aware for a long time that an early marker of HF is an imbalance in the autonomic nervous system and can lead to HF morbidity and mortality, but it has only been able to treat one side of the problem using prescription medications.
"If the study of the CardioFit proves successful, this may be key to understanding how to treat and prevent the progression of HF," Ewald added.
The study expects to enrol up to 650 patients at up to 80 centres in the US and Europe, according to the company.
The company said it will use results of the INOVATE-HF study to support CardioFit system's premarket approval application (PMA) to the US Food and Drug Administration (FDA).