Israel and Minnesota-based BioControl Medical won FDA approval to proceed with the 3rd and largest phase of its INOVATE-HF trail, evaluating its CardioFit vagal nerve stimulation system in treatment of heart failure.
The global, multi-center trial aims to provide clinical data in support of BioControl’s premarket approval application for FDA clearance of the CardioFit system, according to a press release.
"While vagus nerve stimulation has been proven effective in treating epilepsy and depression, its ability to treat heart failure has not, until now, been evaluated in a large pivotal study," INOVATE-HF principal investigator Dr. Kimberly Parks said in prepared remarks. "I believe INOVATE-HF is a very important clinical trial that, in addition to advancing the science behind heart failure, may ultimately lead to a breakthrough new treatment modality for patients."
CardioFit works by stimulating the vagus nerve, a long nerve that runs from the midsection to the brain stem and helps regulate the heart beat. The clinical study is designed to "explore the CardioFit’s potential to help treat one of the hallmarks of HF: an imbalance in the autonomic nervous system, which regulates involuntary bodily functions including heart muscle activity."
The new FDA trial approval grants BioControl unconditional study expansion to the full enrollment of 650 patients at 80 centers around the globe.
The medical device maker previously won backing from pure-play medical device giant Medtronic (NYSE:MDT), which in 2010 announced plans to invest $70 million into BioControl. The investment would give Medtronic the option to acquire BioControl for $550 million if CardioFit wins U.S. regulatory approval. If the device doesn’t receive Food & Drug Administration approval , the price of the option drops to $350 million, according to old reports from an Israeli media outlet.
