any info on the obtech lap band by J & J

[alohajo 1]

does anyone have the obtech lap band by Johnson and >Johnson and does anyone know if it is close to being FDA approvied_

[kleta 0]

:)I would also liKe some info.

Anyone?

[faithmd 14]

Here's the article found at this link:

Ethicon Endo-Surgery, Inc., Files For FDA Approval Of New Gastric Band For Treatment Of Morbid Obesity

Ethicon Endo-Surgery, Inc., Files For FDA Approval Of New Gastric Band For Treatment Of Morbid Obesity

Article Date: 16 Apr 2007 - 0:00 PDT

Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, today announced that it has submitted a Premarket Approval (PMA) application with the U.S. food and Drug Administration (FDA) for its adjustable gastric band, an implantable device intended to treat morbid obesity.

The company's submission includes results from a prospective multi-center clinical trial of 276 patients with a body mass index (BMI) of 40 or more (100 pounds or more above ideal body weight) or a BMI of 35 or more, with one or more obesity-related conditions such as Type 2 diabetes. The primary endpoint for the study was percent of excess weight loss at three years. Patients with these BMI are classified as morbidly obese.

The clinical trial was designed to evaluate the safety and effectiveness of the device, which has been commercially available outside the U.S. since 1996 and has been implanted in over 100,000 patients worldwide. The device is a soft, adjustable band that is fitted around the uppermost part of the stomach during laparoscopic surgery, creating a small pouch and restricting food consumption.

"The submission of this application to the FDA is an important milestone as we seek to provide the bariatric community more treatment options and solutions for morbid obesity, a life-threatening disease that continues to grow throughout the world," said Kenneth Sumner, Ph.D., vice president, Worldwide Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. According to the American Society for Bariatric Surgery (ASBS), about 15 million people in the U.S. have morbid obesity, and in 2006, about 177,000 people had some type of bariatric surgery.

About Ethicon Endo-Surgery, Inc.

Ethicon Endo-Surgery, Inc., develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information on the company can be found at http://www.ethiconendo.com.

[fabfatgrl 10]

I'm wondering what they've done to improve the old Obtech Band. From what I remember back in 2001, the Obtech band needed a special solution for fills. It was also more prone to slippage vs. the Lap-Band.

[lepez 0]

FAITHMD,

You are always a wealth of medical info. I am an RN and appreciate the fact that you always give us the links to increasing our knowledge. By the way........My doctor said that the company who makes the VG band will be putting out an updated version in 2008. Do you have any info on that beacuse I can't find anything. Thanks.

[faithmd 14]

FAITHMD,

You are always a wealth of medical info. I am an RN and appreciate the fact that you always give us the links to increasing our knowledge. By the way........My doctor said that the company who makes the VG band will be putting out an updated version in 2008. Do you have any info on that beacuse I can't find anything. Thanks.

I do not know anything about an updated "VG" but the company that makes the bands currently in use in the US which includes the VG is Allergan, you can go to their website at lapband.com there may be news there. I would find this very interesting becausr they just released a new version of the band last month at the ASBS conference to the US called the AP or Advanced Platform band. It is basically an updated VG which is an updated LapBand. I'd be surprised to see them release another updated band in less than a year. Especially since they just used some of the VG technology in the new AP.

[lepez 0]

Thank you so much for responding. I thought the same thing. I will just have to ask my Dr. to give me the name of the new band and Peg him down tell me the release date.

[Beckie9395 0]

I just went to the website that was posted in the message below. Then I found an updated article:

FDA Approves REALIZE™ Adjustable Gastric Band For Morbid Obesity

This says that the "Realize" band by Johnson and Johnson, was just approved. Nothing about Obtech. I have the same one, so I have sent an e-mail asking them if it is the same thing. I am having trouble findining anyone in the states (in my area as well) to do fills.