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Trials and tribulations

VBLOC pushes ahead with FDA approval despite trial failure

EnteroMedics' VBLOC device
Device achieves clinically significant excess weight loss, but fails to meet trial's efficacy endpoint
EnteroMedics' CEO: "Data from the trial clearly demonstrate VBLOC Therapy's positive effect on weight loss"

EnteroMedics, developers of the VBLOC Therapy device, have announced that it has failed its pivotal trial, after patients implanted with the device did not demonstrate sufficient weight loss compared to a control group. However, the company sayd that the device did still engender clinically significant weight loss, and that they will continue to seek FDA approval for their product.

Patients in the study implanted with the VBLOC, which induces satiety by using electric impulses to block the vagal nerve, had lost 24.4% of their excess weight at 12 months, higher than the 15.9% excess weight loss in patients installed with a sham device.

However, the 8.5% difference, while statistically significant, did not meet the primary efficacy outcome measure, which called for a 10% or greater difference in excess weight loss between the two groups.

3.1% of patients implanted with the device experienced a serious adverse event during the trial, meaning that the device easily surpassed its safety endpoint, which called for a complication rate under 15%.

Defending the results of the trial, Dr Mark B Knudson, EnteroMedics’ president and CEO, said: "Even though we did not reach the predefined efficacy thresholds, data from the ReCharge trial clearly demonstrate VBLOC Therapy's positive effect on weight loss, while adding to an excellent safety record.

"Based on these compelling results, and the totality of our clinical experience with the Maestro System, which now includes more than 600 patients worldwide, we believe EnteroMedics is well positioned to deliver this novel therapy to people with obesity in the USA."

Knudson said that EnteroMedics are now preparing an FDA premarket approval for the device, which, if successful, would allow them to market the device in the USA. The company is also working on plans for the use of the VBLOC for other indications, including type 2 diabetes and hypertension.

Dr Robin Blackstone, investigator in the trial and medical director of Scottsdale Healthcare Bariatric Centre, Arizona, said: “If approved, VBLOC will fill a significant gap in the treatment spectrum, offering a unique approach that supports a healthy lifestyle and addresses the lifelong challenges associated with obesity and its comorbidities.”

The pivotal trial involved 239 patients randomised into a clinical group, which had an active VBLOC device implanted, and a control group, which had an inactive device implanted which was not connected to their vagal nerve.

Patients were recruited in ten centres in Australia and the USA, and were eligible for the trial if they were aged 18-65 and had a BMI between 40-45, or 35-40 with one or more severe comorbidity.

Just over half – 52.5% – of the patients in the clinical group achieved an excess weight loss over 20%, compared to 32.5% of the patients in the control group.

New COO

EnteroMedics also announced that Mr Greg Lea, the company’s senior vice president and chief financial officer, has also been appointed as chief operating officer. He will take responsibility for regulatory matters and commercialisation of the VBLOC device.

Knudson said: “With our attention now fully on the US regulatory process and its associated activities, his leadership and depth of knowledge provide a strong basis for successful management of the critical period the company’s operations are now entering.”

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