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FDA approves novel obesity device

Published on 16/01/15 at 10:17am
VBLOC image
VBLOC targets the nerve pathway between the brain and the stomach to regulate feelings of hunger

The US Food and Drug Administration has shown the green light to US firm EnteroMedics’ new obesity device VBLOC that could cost between $15 and $30,000 per patient.

The Maestro Rechargeable System (VBLOC) is approved to treat obese adults who have not been able to lose weight using a programme and have a body mass index of 35 to 45, or type 2 diabetes.

The pacemaker-like device targets the nerve pathway between the brain and the stomach to regulate feelings of hunger and fullness. Implemented surgically into the abdomen the appliance can be recharged by the patient, plus doctors can adjust its settings using external controls.

“VBLOC therapy offers an entirely new approach to the treatment of obesity,” comments EnteroMedics chief consulting medical officer, Scott Shikora. “It can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss.”

According to some analysts shares in the US company have risen by as much as 75% following news of the FDA nod.

Results from clinical trials involving 233 patients showed that those implanted with the gadget lost on average 8.5% more weight than the control group. However, the study did not meet its original primary endpoint detailing that participants would lose 10% more of their body weight than the accompanying assembly.

“Obesity and its related medical conditions are major public health problems,” says William Maisel, who is the deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “Medical devices can help physicians and patients to develop comprehensive obesity treatment plans.”

As part of the approval for the appliance, the US firm must conduct a five year post approval study to collect additional safety and effectiveness data.

VBLOC may be the first-of-its-kind to enter the market, but it’s not the only treatment out there for this widespread condition. Recently the FDA approved Orexigen’s Contrave (naltrexone HCL/bupropion HCl), and in 2012, Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).

These were the first new obesity drugs sanctioned in the US since Roche’s Xenical (orlistat) in 1999. But most recently the US regulator showed Novo Nordisk’s Saxenda (liraglutide) pill the green light, which according to analysts could generate at least an extra $1 billion in revenue for the company.

According to the World Health Organization obesity has now reached epidemic proportions globally, with at least 2.8 million people dying each year as a result of being overweight.

Tom Robinson

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