Study: BIORING is comparable to LAPBAND device

The adjustable BIORING gastric ring (Cousin Biotech) is as safe and effective as the LAPBAND ring (Allergan), according to the results from a randomised study1 presented at the French society of obesity surgery (SOFFCO), in June 2013, realized by Pr Chevallier.

The RESULTS confirm the outcomes from a previous abstract, ‘Randomized Controlled Study Comparing LAGB with Bioring and Lapband: One Year Outcome (Obesity Surgery 2009 19:953–1076, O-031, p 961)’, and adds to the growing body of evidence supporting the use of the BIORING gastric ring for treating morbid obesity.

BIORING gastric ring

The BIORING adjustable gastric band system is indicated for excess weight loss in people suffering from morbid obesity with a BMI>40 or 35 to 40 associated with at least one co-morbidity.

The adjustable gastric band is made of a supple silicone monoblock body with a unique bellow system, a silicone catheter labelled with arrows, a connector and a low profile injection port.

BIORING was designed to prevent complications and its unique bellow inflation system incorporates an extra low pressure system making inflation less traumatic. This bellow msystem is also designed to have a shock absorbing effectm to follow the natural peristaltic movements of the stomach. Its monoblock, pre-shaped band body helps avoid leakages and the supple silicone allows for a non-traumatic usage.

BIORING has a large surface of contact on the stomach to avoid slippage. It also facilitates a multidirectional distribution of forces. Following inflation of the device, mmultiple forces are spread in several directions, thus decreasing pressure on the stomach.

The BIORING adjustable gastric band system

The device’s unique self-adhesive port eases the implantation, with reduced operative time and less postoperative pain for the patient (no stiches are required). In addition, the larger surface of the septum facilitates saline injection to adjust the band and it improves patient comfort. According to the company, the BIORING can easily be inserted through a 12mm trocar and was specifically designed to avoid complications such as erosion, slippage and pouch dilation.

The BIORING, which was designed for the Pars Flaccida technique, offers a trauma free passage in the narrow retro-gastric tunnel with its streamlined components. In addition, its circular memory form allows encircling without pressure on the stomach.

Study

The randomised study1 was designed to compare the effectiveness and safety of two models of adjustable ring: The low pressure BIORING band and the high-pressure LAPBAND gastric ring.

The prospective and multicentre, randomised study reported the percentage of excess weight loss after 12 months, as well as the mortality and severe peri- and post-operative device-related complications.

Outcomes

The study included 59 patients: 28 patients received the BIORING gastric ring and 30 patients received the LAPBAND device. The study researchers reported no significant differences between the two groups regarding age, weight, frequency of complications and arterial pressure.

The outcomes reveal that there were no deaths and the rate of complications was comparable in both groups: six in the BIORING group and seven in the LAPBAND group (p=0.19).

At 12 months, the percentage of excess weight loss was 42.3±20.6% in the BIORING group and 36.5±19.9% in the LAPBAND group (p=0.269). In addition, the quality of life measured by the SF-36 score and the Impact of Weight on Quality of Life (IWQOL) was comparable in both groups at 12 months.

The study researchers were from CHRU of Lille, the European Hospital Georges-Pompidou. Paris, Bruxelles, Belgium and the Hôpital Louis-Mourier, Paris, France. They concluded “at 12 months the effectiveness and safety of the BIORING and ALLERGAN’s rings are comparable”.

References
1.Devienne M, Caiazzo R, Chevallier J-M, Himpens J, Verhelst H, Pattou F, Msika S, ‘Comparison of the laparoscopic implantation of an adjustable BIORING gastric ring versus the VANGUARD: Randomized prospective study’, Obésité Volume 8, Issue 2, June 2013, p 63-68, article 1.11