Medical Device Daily

Electro-cardiac devices are normally implanted in the chest, electro-neurological devices usually in the neck or in or near the brain — and among these neurostimulators reference the Activa Deep Brain Stimulation Device from Medtronic (Minneapolis) for Parkinson’s disease; the stroke therapy system from Northstar Neuroscience (Seattle); and the vagus nerve stimulation (VNS) technology from Cyberonics (Houston) for treatment of epilepsy and depression.

Now comes an Israeli company, BioControl Medical (Yehud), which is developing a neurostimulator technology to stimulate the vagus nerve but targeting therapy of the heart, requiring implantation in both neck and chest.

Called CardioFit, the device is designed to improve heart function through the controlled stimulation of the vagus nerve, the company says. It notes that preclinical and preliminary clinical data demonstrate that VNS has a therapeutic role in treating heart failure by reducing the heart rate and ventricular volumes in addition to restoring regular rhythm.

Ehud Cohen, CEO of BioControl, in emailed responses yesterday to questions from Medical Device Daily, said the CardioFit system consists of “an electro-stimulator device with a nerve cuff electrode and an intra-cardiac electrogram (EGM) sensor.” It is considered a Class III device, which would require premarket application approval by the FDA.

“By continuously monitoring the EGM signal, stimulation is adjusted to the patient’s heart rate,” Cohen wrote. “The vagus nerve is stimulated through a tri-polar cuff electrode that provides accurate control over specific nerve fibers, thus avoiding cross activation of undesired fibers.”

The device can be implanted quickly, with the electrode positioned around the vagus nerve in the neck, the device itself placed in a subcutaneous pocket in the chest.

Cohen wrote that the risks of implantation are similar to the risks of any surgery under general anesthesia, and the risks of having the implant remain in the body are similar to those of other implantable neurostimulators.

“The CardioFit system is a novel therapy designed for a clinically unmet need,” said Cohen. “Of the existing neurostimulation device therapies currently in clinical development for cardiology indications, the CardioFit system is clearly the most advanced and has the most significant probability for success.”

The company says also that CardioFit has been found to provide significant benefit to the heart when used simultaneously with “other existing optimal medical therapies.”

The company said this week it is beginning an open-label pilot study of the CardioFit device.

It said that the primary endpoint of the study is to determine the occurrence of all adverse events resulting from the system and/or the implant procedure. Secondary endpoints include symptomatic, functional and structural status, as well as a review of biological serum markers. Investigators expect to enroll 20 to 30 patients, all between the ages of 18 and 75. Patients enrolled in the study will be followed for one year.

The company estimates that 1.2% to 2% of the global population suffer from heart failure and as many as 10% of individuals ages 65 years and older.

Although BioControl is now conducting its trial at study sites in Europe, Israel and Australia, it expects ultimately to include sites in the U.S. if it receives a green light from the FDA.

Dr. Paul Hauptman, director of heart failure, St. Louis University Hospital (St. Louis, Missouri), said, “I have closely followed the development of the CardioFit system and am hopeful that sites in the U.S. will soon join the clinical program and begin enrolling for this very important study.”

BioControl, which has 35 employees, was founded in 1999. In April 2006, American Medical Systems (Minnetonka, Minnesota) secured an exclusive license to BioControl’s technology for its miniaturo system to develop it as a treatment device for urge incontinence and interstitial cystitis (MDD, April 28, 2006).

BioControl said it is using the funds gained through that transaction to support development of the CardioFit system. MDD reported in May that the transaction was valued at $25 million in cash for BioControl, with an additional $25 million in potential milestones over the next 10 years or sooner (MDD, May 9, 2006).

The current trial is being conducted at the following clinical sites: Policlinico S.Matteo University Hospital (Pavia, Italy): Otto-von-Guericke University Hospital (Magdeburg, Germany); University Hospital Maastricht (Maastricht, Netherlands); Ospedali Riuniti (Bergamo, Italy): Clinical Center of Serbia (Belgrad, Serbia); Royal Melbourne Hospital (Melbourne, Australia); and Chaim Sheba Medical Center (Tel Hashomer, Israel).