CerebralRx's FitNes system launched in Europe

It's been a big week for CerebralRx, which recently spun off from Israel's BioControl Medical. The company announced the launch of its FitNeS vagus nerve stimulation system designed to treat epilepsy patients with partial onset seizures who do not achieve full seizure control with available prescription drugs.

Surgeons successfully implanted the system in the first two patients at the Institute for Clinical Neurosciences at the Shalgrenska Academy in Götenberg, Sweden. CerebralRx also received its first order for the FitNeS system from the AMS Group, a leading distributor of neuromodulation medical devices in Italy.

The FitNeS system consists of an implanted stimulator and stimulation lead that work together to deliver electrical signals to the left vagus nerve. The system effectively activates nerve fibers toward the brain while minimizing the activation of non-related nerve fibers. This selective approach has the potential to increase stimulation effectiveness while minimizing risk of side effects.

The idea that the system could be used to treat epilepsy came from CerebralRx's parent, which has developed the CardioFit system. CardioFit works to effectively treat heart failure through vagus nerve stimulation, and the system has received the CE mark and is being studied under an IDE in the U.S. Back in April, the company announced the enrollment of the first patient in the INOVATE-HF clinical study at Northwest Texas Heart Hospital, Amarillo, TX.

Seeing the success in heart failure patients, BioControl also saw the potential for using the technology to treat epilepsy. In hopes of attracting new funding, the company spun off its its epilepsy treatment business into CerebralRx, Medical CEO Ehud Cohen told FierceMedicalDevices. He added CerebralRx was in an interesting position because was formed so recently, yet was able to get its product to the market so quickly.

Regarding the technology itself, Cohen emphasized that FitNes system is easier to implant than other currently available therapies and is more effecient because it activates more nerve fibers. It also allows for more stimulation directed toward the brain.

The company is focusing its efforts with the product on Europe and the U.S. and may look at other markets at a later point, Cohen told FierceMedicalDevices. Down the road, the company hopes to study the use of the product to treat depression and Alzheimer's, he added.

The FitNeS system is not available in the U.S.

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