A.M.I. B-Band An opportunity in 2013 & beyond?

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What can you see on this drawing?

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The 20 to 30% failure rate of long lasting loss of excessive weight after- RYGB and- Sleeve GastrectomyProcedures!

age [years]

weight [kg]

A.M.I. B-BandIs there any scientific prove that LRYGB banding works?

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1. Surgery for Obesity and Related DiseasesVolume 1, Issue 6 , Pages 569-572, November 2005Fifty consecutive patients with the GaBP Ring™ system used in the bandedgastric bypass operation for obesity with follow up of at least 1 yearMathias A.L. Fobi, M.D., et.al.The GaBP Ring™ system was used in 50 patients undergoing gastric bypass surgery, 9 with an open procedure and 41 with a laparoscopic approach. Placement took an average of < 5 minutes, and there were no GaBP ring system–related complications at the 1-year follow-up.

2. Obesity SurgeryVolume 22, Number 2 (2012), 271-278, DOI:10.1007/s11695-011-0555-2 Clinical ReportTen Years Experience of Banded GastricBypass: Does It Make a Difference?William Awad, et.al.There is a significant difference in %EWL from the third year until the tenth year of observation, with the proportion being 82% in BGBP versus 63% in nonbanded GBP patients at the end of the study. There is a clear advantage in terms of %EWL in the BGBP patients.

Source: Bariatec Corp. / USA

A.M.I. B-BandIs there any scientific prove that LRYGB banding works?

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3. Obesity Surgery(2010) 20:1491–1495Weight Loss Outcome After Silastic RingRoux-en-Y Gastric Bypass: 8 Years of Follow-upAntonio Carlos Valezi, et.al.ConclusionsThe %EWL in 8 years, demonstrated by BMI, showed a reduction of 70.3±17.2% after the first year, 74.3±17.6% on the second year, 71.4±16.5% after the fifth year, and 69.7±13.6% on the eighth postoperatively year in the group of patients with BMI <40 kg/m [1].DOCTORS

Source: Bariatec Corp. / USA

4. BANDED VERSUS NON-BANDED LAPROSCOPIC GASTRIC BYPASSLemmens L.1 / 1AZ Nikolaas, General Surgery, Sint-Niklaas, BelgiumBackground: The laparoscopic gastric bypass (LGB) is one of the most frequently performed surgical procedures for the treatment of the morbidly obese patients and is by many still considered as the gold standard. The mean excess weight loss amounts to 75 % in the first 2 till 3 postoperative years. Long term results however only show a 60 % excess weight loss and this because of an important weight regain in around 30% of the bypass patients!

Banded Gastric Bypass Procedure

A roven procedure– publication with 14 years follow-up– evidence of effectiveness

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EW

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years follow-up

Excessive Weight Loss (%) Comparison of Surgical Techniques

Gastric Band

RY-GBP

Banded RY-GBP

Sidy by Side comparison / Fobi-Ring vs A.M.I. B-Band

B-Band

soft material fully adjustable size

- differs from surgery to surgery: - different patient conditions - reduced stock keeping / cost

Broad, soft band- reduced risk of slippage- reduced risk of band erosion

Ears (flaps) - for secure fixation of band with

absorbable sutures!

stiff, edges different fixed sizes

- 6 / 6.5 / 7 cm- increasing cost / stock keeping - -

Small, rigid ring - high risk of slippage - high risk of ring erosion.

No ears (suture fixation)- increased risk of ring dislocation-

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Fobi Ring

A.M.I. B-Band – featuring a new, easy, one size fits all closing mechnism!

Important:The band must be loose aroundthe stomach pouch after closing, to allow post op edema of the pouch.

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3 markings: at 5, 6, 7 cm circumference

A.M.I. B-Band:

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Standard Gastric Bypass Banded Gastric Bypass Banded Sleeve Gastrectomy

Pictures: Bariatec Corp. / USA

A.M.I. B-Band:

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Why is a Banded Bypass better?Many thousands of patients have had a Banded Bypass.In published medical scientific papers, the Banded Bypass has been shown to give much better long-term weight loss after three yearsAt 10 years, the average bypass patient has lost around 50% of their excess weight and many are regaining weight.With a Banded Bypass, patients have lost on average 70% of their excess weight and mostly do not regain weight.

Are there more complications?The medical literature comparing the two procedures shows no signicant difference in complication rates.

How much more does it cost?The additional cost of a Banded Bypass issmall, but the benefits over the medium and long term are huge.

Source: Bariatec Corp. / USA

Reports have shown increased weight loss in more patients and less weight regain with the prevention of the formation of this large gastric reservoir.

Since Roux-en-Y Gastric Bypass is primarily a restriction operation,

just as with VBG, it is important that the outlet of the pouch does not stretch.”

( E.Mason . Obesity Surgery 1994;4:66-72)

A.M.I. B-Band: Banding the Gastric Bypass & Sleeve Gastrectomy Operation?

Based on these reports , MacLean in 1997 stated that:

The most promising technique based on a large series at this time is that described by

Capella and Capella

“Banded Gastric Bypass”

MacLean J Am Coll Surg 97;185:1-7

A.M.I. B-Band: Banding the Gastric Bypass & Sleeve Gastrectomy Operation?

Fisher after an in depth review concluded in 1999 that:

“ Long-term results suggest that a silastic ring encircling the stomach pouch proximal to the gastroenterostomy may improve the outcome following gastric bypass surgery, resulting in more weight loss by a greater number of patients sustained for a longer time”

Fisher BL, Barber AE, Eur J Gastroenterol Hepatol 1999; 11:93-97

A.M.I. B-Band: Banding the Gastric Bypass & Sleeve Gastrectomy Operation?

Banded Gastric Bypass Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric

bypass in the super obese.Marc Bressler, SOARD, July/August 2007

LAP Banded GBP Lap Non-Banded GBP (n=46) (n=44)

BMI 59.4 59.7Age (years) 40.6 42.66months %EWL 43.1 24.712months %EWL 64.0 57.824 months %EWL 64.2 57.138months %EWL 73.4 57.7Complications %(n) 23.9 (11) 29.5 (13)% of patients achieving 50%EWL 63% 45%

His conclusion: It appears the banded gastric bypass produces more weight loss in more patients

A.M.I. B-Band: Banding the Gastric Bypass & Sleeve Gastrectomy Operation?

A.M.I. B-Band: What does competition offer?

Bariatric Bypass Ring (Fobi Ring)/ USA:- comes in 4 sizes- rather rigid closing area &

Today Market leader!Sells for 400,- to 600,- EURO / Unit.

Minimizer Ring / Synmed / UK:

Pricing: below the Fobi-Ring Implant!

A.M.I. B-Band: What does competition offer?

Bariatric Bypass Ring (Fobi Ring)/ USA:- comes in 4 sizes- rather rigid closing area &

Today Market leader!Sells for 400,- to 600,- EURO / Unit.

Minimizer Ring / Synmed / UK:- comes in 4 sizes

Pricing: below the Fobi-Ring Implant!

And that’s it………………..there is no more competition!There are

80.000 RYGB and SG procedures waiting for us in Europe15.000 in Asia / Pacific Region 4.500 in Australia!

What an opportunity for You and us!Let’s go for it!