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BACKGROUND A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university(More)
High-frequency alternating current (HFAC) is known to disrupt axonal conduction in peripheral nerves, and HFAC has much potential as a therapeutic approach for a number of pathological conditions. Many previous studies have utilized motor output as a bioassay of effects of HFAC on conduction through medium- to large-diameter motor axons. However, little is(More)
BACKGROUND A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking (VBLOC therapy). The aim is to assess the effects of vagal blocking on excess weight loss (EWL), safety, dietary intake, and vagal function. METHODS An open-label, 3-center study was conducted in obese subjects (body mass index [BMI] 35-50(More)
IMPORTANCE Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS A randomized, double-blind, sham-controlled clinical(More)
BACKGROUND An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies. OBJECTIVE To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2. METHODS Twenty-eight subjects were implanted(More)
BACKGROUND/OBJECTIVES Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year. SUBJECTS/METHODS The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation(More)
BACKGROUND AND AIMS OF THE STUDY The biocompatibility of a silver-coated polyethylene terephthlate (PET, polyester) fabric for the inhibition of prosthetic valve endocarditis (PVE) associated with mechanical heart valves (MHVs) was assessed. The infrequency of PVE is outweighed by mortality rates commonly exceeding 50%. These high mortality rates have been(More)
BACKGROUND AND AIMS OF THE STUDY Prosthetic valve endocarditis (PVE) is an infrequent but serious complication of cardiac valve replacement. PVE is a foreign body infection predominantly based in the sewing cuff of a prosthetic heart valve leading to thromboembolism, ring abscess, paravalvular leakage, and eventual invasion of the myocardium. Mortality(More)
BACKGROUND The long-term patency rate of saphenous vein grafts for myocardial revascularization is poor (50% at 10 years). Half of the patent grafts develop severe atherosclerosis. In this paper, we report on an implantation technique and an in vivo evaluation of a device that creates a ventriculocoronary artery bypass (VCAB), a permanent transmyocardial(More)
BACKGROUND In this report we describe the in vivo evaluation of a device and ventriculocoronary artery bypass procedure that creates a permanent transmyocardial channel between the left ventricle and a coronary artery. METHODS The transmyocardial device, an L-shaped titanium tube with a meshed distal tip and an exterior polyester cuff, was implanted from(More)