Hvorfor skal jeg vælge Spatz3 ballon?

The Spatz3 Adjustable Balloon was developed to achieve:

– Adjustment to prevent early extraction for intolerance
– Adjustment to achieve renewed balloon effect after the 4th month
– Adjustments in combination with 1 year implantation
– Medically significant weight loss maintenance two years after balloon removal

Why do we need to adjust balloons?

* Prevents early extractions for intolerance
– 22{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Orbera balloons extracted early in FDA trials [1]
– Approximately 10-12{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Spatz3 patients undergo down adjustments for intolerance[2,3,4,9]
* Prevents weight regain at month 4-5 of balloon implantation
– publications document that balloons lose their effect at 3-5 months [5,6,7]

Does that improve results?

– Published results report response rates (>10{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd}TBL or >25{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd}EWL)
* Orbera balloon response rates 46.4{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} and 45.6{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd}, respectively [1,7]
* Reshape Balloon 48{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} response rate [8]
* Spatz3 Adjustable balloon 83.3{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} response rate [9]
* That means that with a non-adjustable balloon less than half the patients have a good response; and with an adjustable balloon >80{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} have a good response.

Why do adjustments improve response rates?

2 reasons

Down adjustments save patients from early extractions

– 22{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Orbera patients had early extractions in FDA trials [1]
– 14{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Reshape patients had early extractions in FDA trials [8]
– Approximately 10-12{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Spatz3 patients undergo down adjustments for intolerance[2,3,4,9]
– 88.7{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of Spatz3 intolerant patients that underwent down adjustment were saved from early extraction [2,3,4,9]

Up adjustments save patients from weight regain after 4-5 months

– Additional weight loss of 8.2kg, 8.9kg, 5kg, and 5.7 kg were achieved after the up adjustment in 4 different studies [2,3,4,9]
– Mean 300 ml addition yields better results than mean 227 ml[9]

Will 1 year implantation of a non-adjustable balloon yield more weight loss?

* Probably not
o It has been well documented that on average balloon effect diminishes after 4 months[5,6,7]
o In fact Orbera studies document weight gain at 4-5 month [7] While the balloon is still implanted
* Keeping the ineffective balloon in for a longer period of time is not likely to help. But studies need to be done.

1. FDA SSED Orbera Balloon. PMA P140008: FDA Summary of Safety and Effectiveness Data. August 5, 2015. 2. Machytka E, Brooks J, Buzga M and Mason J (2014) One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons [v1; http://f1000r.es/471] F1000Research 2014, 3:203
3. Machytka E, Marinos G2, Kerdahi R, Srivastava ED, AlLehibi A ,Mason J, Brooks J. Spatz Adjustable Balloons: Results of Adjustment for Intolerance and for Weight Loss Plateau. DDW 2015, IFSO 2015
4. Brooks J, Tsvang E, Ganon M, Arnon R. Spatz3 Adjustable Balloon: Early adjustment to prevent premature extraction. DDW 2016 Courcoulas published results of 255 patients in a randomized controlled study (modified intention to treat). The patients achieved 10{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} TBL (loss of 10{3f8d46f91a764009cda241f03edb0528c65ecb14c28961ccd6e449df31bdddfd} of initial weight). Notice that the weight regain begins at 4-5 months – that is 1-2 months prior to Orbera balloon removal. This means that balloon effect diminishes and weight regain begins already at 4-5 months. This is most likely true of all balloons. Orbera Balloon removed at 6 months Weight regain begins at 4-5 months while the balloon is still implanted
5. Bonazzi P, Petrelli MD, Lorenzini I, et al. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005; 9(5 Suppl 1):15–21.
6. Totte E, Hendricks L, Pauwels M, et al. Wt reduction by means of an intragastric device; experience with BIB. Obes Surg. 2001; 11(4):519–23.
7. Courcoulas A et al. Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial. International Journal of Obesity (2017) 41, 427–433
8. FDA SSED Reshape Duo Balloon. PMA P140012: FDA Summary of Safety and Effectiveness Data. July 28, 2015
9. Machytka, Evzen; Puig Divi, Valenti; Saenger, Fernando; Sorio, Ricardo; Brooks, Jeffrey. Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared with Non-Adjustable Balloons. DDW 2017 Abstract.

Since May 2012 over 30,000 Spatz3 Adjustable balloons have been implanted worldwide.

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