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VBLOC Therapy

FDA recommends VBLOC vagal blocking therapy

If approved, the Maestro Rechargeable System will be the first new medical device approved for obesity by the FDA in over ten years

The FDA Advisory Gastroenterology and Urology Devices Panel (GUDP) has voted eight to one in favour of EnteroMedics’ neuroblocking technology to treat obesity, the Maestro System. The Panel voted that the device is safe when used as designed and voted four to five against on the issue of a reasonable assurance of efficacy.  The final vote, on whether the relative benefits outweighed the relative risk, was six to two in favour, with one abstention.

Although the FDA is not bound by the GUDP's recommendation, it will take the decision into consideration when reviewing the Maestro System Premarket Approval (PMA). The company expects a decision on approval of the PMA later in 2014, which if approved, the Maestro Rechargeable System will be the first new medical device approved for obesity by the FDA in over ten years.

VBLOC vagal blocking therapy, delivered by a pacemaker-like device called the Maestro Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses, which helps control both hunger and fullness. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort.

In the most recent clinical trial, the ReCharge Study, VBLOC Therapy treated patients demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) at 12 months of 24.4%, sustained out to 18 months. The majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy treated patients lost 30% or more. The 24.4% average EWL far exceeds the 10% to 15% thresholds at which patients experience substantial positive health effects.

Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference.

"Where existing options are clearly failing to address the growing epidemic of obesity, we believe VBLOC Therapy may offer a unique approach to treating obesity, a choice that fills this void by offering a safe, reversible option that does not alter the anatomy, allowing patients to take a positive path towards improving their overall health,” said Greg Lea, Senior Vice President, COO and CFO of EnteroMedics. “We thank the Committee members for their insights and look forward to a continued, productive dialogue with the FDA."

EnteroMedics' Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.

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