OpiniOn | WEIgHTMAnAgEMEnT | 40% of these procedures, with a slightly
higher proportion being adjustable gastric banding. Total sleeve gastrectomies accounted for fewer than 5% of procedures. However, while the number of
procedures carried out annually continues to rise, the rate of growth appears to be slowing. Between 1998 and 2003, the number of procedures carried out worldwide increased by 266%, while between 2003 and 2008 the increase was only 135%. And there also appear to be significant
differences in the way the use of bariatric surgery is developing on either side of the Atlantic. In 2003, 63% of all procedures in Europe
were
version designed to address a wider patient population, was introduced in 2004; and in 2007, Allergan launched the Lap‑Band AP System, which is designed to distribute pressure evenly throughout the band’s adjustment range. More recently, in 2009, Allergan submitted an sPMA to the FDA for the use of the Lap‑Band System in adolescents aged 14–17 years. The most recent addition to Allergan’s
between 1998 and 2003, the
adjustable gastric banding procedures, but by 2008 this proportion had fallen to 43%. In the US and Canada, over the same period, the use of gastric banding increased from 9% to 44% of all procedures. The situation with Roux‑en‑Y gastric bypass was the opposite: use in north America declined from 85% to 51% of all procedures, while in Europe uptake increased from 11% to 39%.
The devices Over the years, a great many devices have been developed and marketed for use in tackling the problem of obesity. Probably the most widely known is the Lap‑Band Adjustable gastric Banding System, originally developed by Inamed Corp, but now marketed by Allergan (since its acquisition of Inamed in 2006). Lap‑Band was the first adjustable gastric
band to be approved in the US for weight reduction, and has now been used in more than 450 000 procedures worldwide since its introduction in 1993 (it was approved by the FDA in 2001). Lap‑Band Vg, a larger circumference
line of gastric banding products is the EasyBand Remote Adjustable gastric Band System, a next‑generation, telemetrically adjustable device for the treatment of morbid obesity (conventional Lap‑Band products are
adjusted number of procedures carried out
worldwide increased by 266%, while between 2003 and 2008 the increase was only 135%.
h y d r a u li c al l y ) . EasyBand was developed
by
EndoArt, a Swiss company acquired by Allergan in February 2007 for $97.1 million.
In addition to its gastric banding product
line, Allergan markets the Orbera Intragastric Balloon System, although only outside the US. The device is inserted via the mouth and filled with saline. It thus reduces stomach capacity and creates an earlier sensation of fullness. It is designed to be used for up to 6 months in combination with a diet and exercise programme, after which it is removed — again endoscopically. Last year, Allergan’s sales of obesity
intervention products were worth $243.3 million, a 5.8% decrease compared with 2009. As such, they represented 29% of total medical device sales and just under 5% of Allergan’s overall sales. Allergan’s main competitor in the
gastric banding market is Ethicon Endo‑Surgery, whose Realize Adjustable gastric Band has been used in patients since 1986. Outside the US, the Realize Band is marketed as the Swedish Adjustable gastric Band (the original design was developed in Sweden). Like
the Lap‑Band, the Realize band comprises a flexible silicone structure that fits around the upper part of the stomach. The inside of the band has a soft balloon that comes in direct contact with the stomach: the amount of saline injected into the balloon controls the degree to which the stomach is constricted. This, in turn, affects how much food can be eaten during a meal. The balloon is filled via the Realize Injection Port, to which it is connected via a flexible tube, and which is attached to the abdominal wall underneath the skin. The Realize Band is a low‑pressure
system, which means that the balloon is not under strain and is more easily able to conform to the shape of the stomach. In addition, it uses a low‑profile injection port that can be placed without sutures, which Ethicon claims offers advantages over the Lap‑Band system. Johnson & Johnson, Ethicon’s parent
company, does not release sales figures for individual products in its medical devices and diagnostics segment. However, Ethicon‑Endosurgery recorded sales of $4,758 million in 2010.
Other companies Allergan and Ethicon are not the only companies active in the gastric band market — other niche players with offerings that claim particular clinical benefits are also vying for a share. One such is the Austrian company AMI (Agency for Medical Innovations), whose Soft gastric Band Premium is positioned as a state‑of‑the‑art device. It is claimed to be soft and gentle to the encircled tissue, therefore reducing the risk of band migration; it also offers a wrinkle‑free shape that minimises the risk of balloon breakage, and an easy to operate closing mechanism. Like the Realize band, the AMI product
is a low‑pressure system. The company says that the volume of saline required to fill it is therefore relatively large,
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76