Studies show new bariatric implant is “safe and effective”

A novel bariatric implant and its delivery system have successfully completed both a proof-of-concept study and a pivotal study, indicating that it can feasibly be safely and effectively used in adult patients.

The Prevail Implant System, designed by California-based start-up Vibrynt, is intended to fill the space that the stomach normally expands into, thereby limiting the patient’s food consumption. Both studies were presented at the ASMBS’ 29th Annual Meeting in San Diego.

The multi-centre, single-arm proof-of-concept study was designed to evaluate feasibility and safety in the device, and included six subjects aged 18-60 years with a BMI between 35 and 55.

69 subjects were evaluated in the pivotal study, which examined safety through adverse events and effectiveness based on excess weight loss. The mean excess weight loss among patients installed with the device was 28.3% ± 14.45% at six months.

Feasibility was based on placement success, and safety was based on severe adverse events. In the pivotal study, the device was successfully implanted on the first attempt in 94.2% of patients.

Severe device-related adverse events in more than one pivotal study subject included abdominal and upper abdominal pain, and medical device removal.

The investigators concluded from the studies that the use of the adjustable, reversible implant in adult subjects appeared “safe and well-tolerated”.

Installation

Vibrynt, and its Prevail system, was formed in California in 2006, in the Exploramed medical device incubator. The device is currently at an investigative stage, to establish whether the patient’s calorific intake can be restricted by filling the space the stomach would normally expand into, thereby inducing early satiety.

Once the ideal location for the device is established using a template tool, the Prevail implant is inserted laparoscopically through a single incision, within the ribcage and next to the stomach. It is then filled with sterile saline.

Once the device is inflated, the insertion tool can suture the device in place. An adjustment port, similar to that seen with an adjustable laparoscopic gastric band, is placed at the incision, which can be used to alter the amount of restriction that the device places on the stomach.

The Prevail System does not require any altering of the gastrointestinal anatomy, and does not place any restrictions on the types of healthy foods the patient can eat.

Future

The system is being evaluated in an FDA-approved research study to support a premarketing application to the FDA.

The purpose of the study is to determine the safety and effectiveness of the system for the treatment of morbid obesity. It will compare the results attained by patients using the Prevail system to those attained using an adjustable gastric band.

Study enrolment is currently scheduled to take place from August 2012 to August 2013. Patients considered for the study will have a BMI between 40 and 50, or between 35 and 40 with one or more comorbidity; be aged between 18 – 65; have a five-year history of morbid obesity; and will demonstrate a documented failure with non-surgical weight-reduction options like diets, exercise and behaviour modification programmes.