BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical study of its CardioFit system for heart failure.
The approval was based on the FDA's safety review of the first two successful completed phases and will enable the company to conduct unconditional study expansion to full enrollment of 650 patients at 80 centers globally.
Started in April 2011, INOVATE-HF is aprospective, randomized, controlled clinical study, which aims to assess the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure (HF).
The study will assess the system's potential to reduce hospitalization and death among patients with HF, besides exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.
Results from study will be used to support a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for market clearance of CardioFit.
BioControl Medical chief executive officer Ehud Cohen said the scientific evidence supporting CardioFit is based on the company's 32-patient European pilot study, which was recently hailed as seminal original research in an editorial of the European Journal of Heart Failure.
"FDA's recent approval of the final phase of INOVATE-HF is a significant milestone that will enable us to rigorously evaluate the system in a very broad global patient population and puts us one step closer to making CardioFit available to physicians and patients across the United States," Cohen added.
