According to a report at the Globes, BioControl Medical, an Israeli company, has received European Union’s approval for its implantable congestive heart failure modulator. The CardioFit™ device, a vagus nerve stimulator, thought to function by reducing the heart rate and improving ventricular volumes, as well as by restoring regular rhythm, has been covered by us before. (See The CardioFit™ System for CHF (February 2007) and New Trial for CardioFit™ System for CHF (August 2007).) The Globes also reports that BioControl Medical is gearing up to initiate a new efficacy trial in the US as part of its strategy to obtain regulatory approval from the FDA.
Here’s a look at the technology behind the device:
The CardioFit system consists of an electro-stimulator device with a nerve cuff electrode and an intra-cardiac electrogram (EGM) sensor. By continuously monitoring the EGM signal, stimulation is adjusted to the patient’s optimal heart rate. The vagus nerve is stimulated through a propriety tri-polar cuff electrode that provides accurate control over specific nerve fibers, thus avoiding cross activation of undesired fibers. The device is implanted in a short, procedure in which the electrode is positioned around the vagus nerve in the neck and the device is placed in a subcutaneous pocket in the chest…
BVPs (Biventricular pacing devices) as an example are pacemakers that seek to coordinate asynchronous ventricular contractions by programming the activity of the left ventricle to perform in concert with that of the right ventricle. Data show that BVP improves cardiac output, optimizes myocardial energy consumption, and reduces mitral insufficiency. With all of this promise, however, researchers hypothesize that only up to 30% of chronic heart failure patients with moderate to severe symptoms may benefit from this technology.
BioControl’s solution for autonomic disorders offers a more universal therapeutic treatment for myocardial infarction that has the potential to reverse the damage caused by this condition and improve cardiac function.
BioControl’s therapy augments the b-blockers’ sympathetic reduction effect by impacting the heart upon demand via parasympathetic selective neurostimulation.