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VBLOC Therapy

VBLOC demonstrates durable and safe weight loss

78% of the patients who reported for their 18-month visit remained under the clinical trial's randomised blind

Eighteen-month efficacy and safety results from the five year ReCharge Pivotal Trial have revealed that patients in the VBLOC group (n=117), achieved excess weight loss (EWL) of 25%, or 10% total body weight loss (TBL), compared to 12% EWL, or 4% TBL for sham control group patients (n=42).

ReCharge Pivotal Trial

The ReCharge Pivotal Trial of VBLOC vagal blocking therapy for the treatment of obesity is a prospective double-blind, sham-controlled clinical trial involving 239 randomised patients (233 implanted) at ten sites in the US and Australia. The trial tested the effectiveness and safety of VBLOC Therapy utilising EnteroMedics' Maestro Rechargeable (RC) System.

All patients in the trial received an implanted device and were randomised in a 2:1 allocation to VBLOC treatment or sham control groups. Patients were surgically implanted with either a fully functional device with leads to the vagus nerve (treated) or received a sham surgical procedure and a sham device without leads to the vagus nerve (sham control). All patients are expected to participate in a weight management counselling programme.

The 13% difference in EWL demonstrated statistical superiority over sham control (p< 0.001). In total, 54% of patients in the VBLOC group achieved at least 20% EWL and 41% achieved at least 25% EWL, compared to 26% and 17%, respectively, for the sham control group at the 18-month interval.

Significantly, approximately 78% of the patients who reported for their 18-month visit remained under the clinical trial's randomised blind.

The rate of device-related serious adverse events at 18 months was 4.3% for the VBLOC group, meaningfully lower than the 12 month threshold of 15% (p<0.0001). The safety results continued to confirm VBLOC Therapy had no adverse cardiovascular effects. Overall, a reduction in blood pressure and heart rate was observed.

“Durable weight loss over time is a critical, if challenging, goal in bariatric medicine, one that plays a significant role in achieving long-term health benefits,” said Dr Mark B Knudson, EnteroMedics' President and CEO. “These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety, underscoring the attractive benefit risk profile of VBLOC Therapy. If approved, VBLOC may help to address the lifelong challenges associated with obesity by offering a treatment option that supports safe, long-term weight loss and a healthy lifestyle.”

Maestro RC System

The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the oesophagus and the stomach.  The Maestro RC System is powered by an internal, rechargeable battery, which is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.

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