BioControl Medical is set to commence the second phase of its INcrease Of VAgal TonE in Heart Failure (INOVATE-HF) study, following the US Food and Drug Administration (FDA) approval.
The CardioFit system, which comprises a stimulator, a sensor lead and a stimulation lead, is designed to alleviate HF symptoms, reverse HF deterioration as well as activate parasympathetic nervous system directly to reduce stress on the heart.
The approval is based on the positive results of controlled, prospective, randomized, initial phase of 50 patients study, which began in April 2011.
The second phase study, which will enroll up to 200 patients at 50 US centers, is designed to assess the CardioFit electrical stimulation device as a treatment for congestive heart failure (HF).
The study will also evaluate the CardioFit system's potential to reduce hospitalization and death among patients with HF, while also explore whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
INOVATE-HF study principal investigator Gregory Ewald said, "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 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).