The CardioFit™ system, a vagus nerve stimulator from Israel’s BioControl Medical, designed for the treatment of advanced congestive heart failure, has now been implanted into two patients in Germany and Italy, according to the Globes. We have profiled this device in February of this year. According to the article, the European trial of the device will involve a total of thirty patients, and will look at the clinical response to the therapy, and its side effects.
Here’s a reminder on how the technology works:
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 therapy augments the b-blockers’ sympathetic reduction effect by impacting the heart upon demand via parasympathetic selective neurostimulation.
Three Nitric Oxide Synthases (NOS) enzymes are described in mammalian systems, all of which play a modulatory essential role in the cardiovascular system. Significant changes in NOS expression levels are known to be related to cardiac diseases.
Pre-clinical study data indicates that the long-term application of CardioFit™ therapy enhances NO production and normalizes mRNA and protein expression of all 3 NOS subtypes in the LV myocardium of dogs with HF. Furthermore, in HF-controls, the mRNA and protein expression of endothelial NOS decreased, and the inducible NOS and neuronal NOS significantly increased, in comparison with normal levels. The CardioFit therapy was shown to normalize all. Additionally, overall NO production as determined by nitrate + nitrite pool, decreased in HF-controls compared to normal and significantly increased with the CardioFit therapy.
Globes article…
BioControl Medical’s website…
UPDATE (8/1/2007) : The post has been renamed. A representative from BioControl Medical has alerted us to the fact that CardioFit system has been in human trials for a while now. We apologize for the mistake.