Spatz Balloon

Company

Spatz

Device

Spatz Balloon

Category

Intragastric Space Occupying

Indication

Primary

Mechanism

Intragastric Restriction

Status

Investigational; not FDA approved

Website/Contact

www.spatzmedical.com

Summary

Attempts at gastric restriction and mechanical satiety by use of a gastric balloon or bag have been present in bariatric literature dating back to the 1980.  At least four balloons which have been trialed are currently obsolete.  The Garren-Edwards bubble made by American Edwards Laboratories of Irvine, California is obsolete.  This was used for a short period of time between 1985 and 1988.  This was a polyurethane cylinder.  Success rates were limited and the safety issues resulted in this being pulled from the market.  Three other balloons are also obsolete and are no longer used.  These balloons are the following:

  1. The silicone rubber acid resistant balloon made by Dow Corning in Midland, Michigan and is no longer used.
  2. The Wilson Cook balloon from Winston-Salem, North Carolina again is obsolete and no longer in use.
  3. The Tremco balloon from Cleveland, Ohio is again obsolete and no longer used.

There are several balloons in use today. At least four of the balloons are saline balloons.  These balloons are the following:

1. The BioEnteric Intragastric Balloon, or “BIB” (trademark), also known as the Orbera (trademark.) 1. The Silimed Intragastric Balloon or “BIS” is a saline balloon. 1. The Spatz(trademark) Adjustable Balloon System< 1. ReShape Intragastric balloon

In addition, there is the Helioscopie, Heliosphere Bag System which is an air based bag or balloon.  The balloons can be briefly summarized in the following manner.  First of all, despite multiple trials, primarily on the BioEnterics Intragastric Balloon, there is no FDA approved balloon system thus far  in the United States.  Current trials are ongoing. Multiple trials within the United States and in other parts of the world have been performed.  The balloons have been used as primary bariatric procedures as well as pre-bariatric procedures with some success.  In other parts of the world, the safety and efficacy have been better than the United States trials.  When evaluating the gastric balloons, it appears that when used appropriately for the right indications, less than  six months at a time under supervision and with appropriate volumes, that the balloons can be safe and provide some, although somewhat limited efficacy(15-50lbs.).  They may be better used for obese but not morbidly obese patients or possibly as pre-bariatric procedures.  The barriers to use of balloons in the United States are its limited efficacy in comparison to diet and placebo and the concerns for life-threatening complications such as obstruction and perforation which have been observed in some studies.

Balloons/Bags

Bioenterics  Intragastric Balloon (BIB / Orbera)

  • Saline filled, 6 months
  • Allergan
  • www.allergan.com
  • www.allergan.com/contact

Silimed Intragastric Balloon (BIS /SGB)

  • Saline filled silicone balloon, 6 month
  • Silimed
  • www.silimed.com
  • www.silimedproductos.com

Spatz Adjustable Balloon System

  • Saline filled,  Anchored, 12 month
  • Spatz Medical
  • www.spatzmedical.com
  • www.spatzmedical.com/contactus

Heliosphere Bag System

  • Air filled, 6 month
  • Helioscopie  SA
  • www.helioscopie.fr/en
  • www.helioscopie.fr/en/contactus

ReShape Intragastric Balloon

  • Saline Filled, Dual Balloon, 6 month
  • ReShape Medical, Inc.
  • www.reshapemedical.com
  • www.reshapemedical.com/contact/

Key Points

  • As of now–NO FDA approval
  • Multiple Trials with multiple balloons/bags ongoing
  • Efficacy in terms of weight loss and co-morbidities uncertain
  • Role/Indications Uncertain
  • Safety Uncertain