Interim Results For The European Pilot Study Of CardioFit For Congestive Heart Failure - BioControl Medical

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 18 Sep 2008 - 4:00 PDT

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BioControl Medical announced the publication of six month data for eight of the more than 30 patients who participated in the overall European pilot study of CardioFit for Congestive Heart Failure. All eight patients were enrolled at the Fondazione IRCCS Policlinico San Matteo and the University of Pavia, Pavia, Italy. The results are published in the European Journal of Heart Failure, volume 10, issue 9, pages 884 - 891.

The article was authored by the study's principal investigator, Professor Peter J. Schwartz, with his associates from Fondazione IRCCS Policlinico San Matteo and the University of Pavia, Pavia, Italy. The article is titled LONG TERM VAGAL STIMULATION IN PATIENTS WITH ADVANCED HEART FAILURE: FIRST EXPERIENCE IN MAN. It describes the use of CardioFit's implantable vagal stimulation system in a pilot study designed to assess, for the first time ever, the feasibility and safety and possible efficacy of chronic vagal stimulation (VS) in congestive heart failure (CHF) patients.

"A significant 40% improvement was observed in the commonly used Minnesota Living with Heart Failure® Quality of Life questionnaire (p<0.001) and in left ventricular end-systolic volume (ca. 9%, p=0.03). A favorable trend toward reduction was also observed in end-diastolic volume. Despite their difficult baseline condition, the patients' NYHA functional class improved significantly," said Professor Schwartz.

The eight patients, all with advanced CHF, had a mean age of 54 years. Two to four weeks after implantation of CardioFit, vagal stimulation was initiated and intensity increased according to a prospective protocol. "It is our opinion as investigators that the CardioFit's novel approach to the treatment of patients with heart failure is feasible, and appears safe and tolerable. The preliminary efficacy results support the commencement of a controlled multi-center study in a larger population to confirm the seeming efficacy of the system," said Professor Schwartz.

"BioControl Medical's implantable neuromodulation technology has a wide range of applications. To date, it is being applied to develop therapeutic devices in urology and for the treatment of congestive heart failure. In parallel with the development of these products, the company is also investigating applications for other indications. The main focus of the company today is the initiation of an international, multi-center, pivotal study of the CardioFit system, which we believe will likely make a significant impact on existing clinical protocols once approved in the US and Europe," said Dr. Ehud Cohen, CEO of BioControl Medical.

The details pertaining to the six month data report on the first 20 patients in the pilot study will be addressed in a presentation at the 2008 American Heart Association annual meeting in New Orleans in November.

About BioControl Medical

BioControl develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results.

BioControl Medical