• Skip to primary navigation
  • Skip to main content
  • Skip to footer

SAGES

Reimagining surgical care for a healthier world

  • Home
    • COVID-19 Annoucements
    • Search
    • SAGES Home
    • SAGES Foundation Home
  • About
    • Who is SAGES?
    • SAGES Mission Statement
    • Advocacy
    • Strategic Plan, 2020-2023
    • Committees
      • Request to Join a SAGES Committee
      • SAGES Board of Governors
      • Officers and Representatives of the Society
      • Committee Chairs and Co-Chairs
      • Full Committee Rosters
      • SAGES Past Presidents
    • Donate to the SAGES Foundation
    • Awards
      • George Berci Award
      • Pioneer in Surgical Endoscopy
      • Excellence In Clinical Care
      • International Ambassador
      • IRCAD Visiting Fellowship
      • Social Justice and Health Equity
      • Excellence in Community Surgery
      • Distinguished Service
      • Early Career Researcher
      • Researcher in Training
      • Jeff Ponsky Master Educator
      • Excellence in Medical Leadership
      • Barbara Berci Memorial Award
      • Brandeis Scholarship
      • Advocacy Summit
      • RAFT Annual Meeting Abstract Contest and Awards
  • Meetings
    • NBT Innovation Weekend
    • SAGES Annual Meeting
      • 2023 Scientific Session Call For Abstracts
      • 2023 Emerging Technology Call For Abstracts
    • CME Claim Form
    • Industry
      • Advertising Opportunities
      • Exhibit Opportunities
      • Sponsorship Opportunities
    • Future Meetings
    • Past Meetings
      • SAGES 2022
      • SAGES 2021
    • Related Meetings Calendar
  • Join SAGES!
    • Membership Benefits
    • Membership Applications
      • Active Membership
      • Affiliate Membership
      • Associate Active Membership
      • Candidate Membership
      • International Membership
      • Medical Student Membership
    • Member News
      • Member Spotlight
      • Give the Gift of SAGES Membership
  • Patients
    • Healthy Sooner – Patient Information for Minimally Invasive Surgery
    • Patient Information Brochures
    • Choosing Wisely – An Initiative of the ABIM Foundation
    • All in the Recovery: Colorectal Cancer Alliance
    • Find a SAGES Member
  • Publications
    • SAGES Stories Podcast
    • SAGES Clinical / Practice / Training Guidelines, Statements, and Standards of Practice
    • Patient Information Brochures
    • TAVAC – Technology and Value Assessments
    • Surgical Endoscopy and Other Journal Information
    • SAGES Manuals
    • SCOPE – The SAGES Newsletter
    • COVID-19 Annoucements
    • Troubleshooting Guides
  • Education
    • OpiVoid.org
    • SAGES.TV Video Library
    • Safe Cholecystectomy Program
      • Safe Cholecystectomy Didactic Modules
    • Masters Program
      • SAGES Facebook Program Collaboratives
      • Acute Care Surgery
      • Bariatric
      • Biliary
      • Colorectal
      • Flexible Endoscopy (upper or lower)
      • Foregut
      • Hernia
      • Robotics
    • Educational Opportunities
    • HPB/Solid Organ Program
    • Courses for Residents
      • Advanced Courses
      • Basic Courses
    • Video Based Assessments (VBA)
    • Robotics Fellows Course
    • MIS Fellows Course
    • Facebook Livestreams
    • Free Webinars For Residents
    • SMART Enhanced Recovery Program
    • SAGES OR SAFETY Video
    • SAGES at Cine-Med
      • SAGES Top 21 MIS Procedures
      • SAGES Pearls
      • SAGES Flexible Endoscopy 101
      • SAGES Tips & Tricks of the Top 21
  • Opportunities
    • NEW-Area of Concentrated Training Seal (ACT)-Advanced Flexible Endoscopy-Coming Soon!
    • SAGES Fellowship Certification for Advanced GI MIS and Comprehensive Flexible Endoscopy
    • Multi-Society Foregut Fellowship Certification
    • SAGES Research Opportunities
    • Fundamentals of Laparoscopic Surgery
    • Fundamentals of Endoscopic Surgery
    • Fundamental Use of Surgical Energy
    • Job Board
    • SAGES Go Global: Global Affairs and Humanitarian Efforts
  • Search
    • Search All SAGES Content
    • Search SAGES Guidelines
    • Search the Video Library
    • Search the Image Library
    • Search the Abstracts Archive
  • Store
    • “Unofficial” Logo Products
  • Log In

TransPyloric Shuttle

May 20, 2019 by Nova Lee Szoka

Britney Harris MD, Nova Szoka MD

BaroNova received FDA approval for TransPyloric Shuttle (TPS) on April 16, 2019.

The TransPyloric Shuttle (TPS) is a minimally invasive treatment for obesity. The TPS system consists of a large and small bulb connected by a flexible silicone tether and an endoscopic delivery device. During delivery, the large bulb is distended with an internal coil and locked into the correct shape. Once the TPS is deployed endoscopically into the stomach, it causes faster filling times and delayed gastric emptying as peristalsis guides the small bulb into the small intestine and the large bulb to the pylorus. This device can remain in the stomach for 12 months, at which time it is retrieved endoscopically after removing the internal coil and collapsing the large bulb.

The randomized, double-blinded clinical trial ENDObesity II compared percent total body weight loss (%TBL) in patients treated with the TPS device versus a sham endoscopic procedure.  Mean %TBL at 12 months for the TPS group was 9.5% compared to 2.8% in the control group (p<0.0001). A statistically significant reduction in insulin-resistance, blood pressure, and lipids was also observed in the TPS group.

The FDA determined this device has no prior substantially equivalent predicate devices.

Indications:

  • Indicated in adult patients with a Body Mass Index (BMI) of 35.0 to 40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with an associated medical condition, such as diabetes, who have failed medical weight loss strategies.

Contraindications:

  • Prior surgery or endoscopic intervention that has altered esophageal, gastric, or duodenal anatomy
  • Structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of an overtube and/or an endoscope
  • Esophageal abnormality such as erosive esophagitis, eosinophilic esophagitis varices, telangiectasia, or other anomalies that could cause bleeding or other procedural complications
  • History of portal hypertension, cirrhosis, and/or esophageal varices
  • Patulous gastroesophageal junction
  • History of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, gastric mass, chronic gastritis, gastric varices, hiatal hernia (> 4cm), pyloric stricture
  • Active gastric or duodenal ulcers
  • Untreated Helicobacter pylori infection
  • Inflammatory and other pathophysiological conditions of the gastrointestinal (GI) tract, such as Crohn’s disease
  • Continuous therapy with known ulcerogenic medication (e.g., aspirin, NSAIDs)
  • Coagulopathy or on anticoagulation or antiplatelet therapy
  • Unable or unwilling to take proton pump inhibitors (PPI), or addition of PPI may cause adverse drug interaction with subject’s medication or interruption of treatment
  • Diagnosis of bulimia nervosa or binge eating disorder or other severe psychiatric disorders
  • Pregnancy or planned pregnancy in next 12 months
  • Known or suspected allergy to any component materials in the device
  • Any medical condition that would not permit elective endoscopy or anesthesia

 

Transpyloric Shuttle 1

2,391

Share this:

  • Twitter
  • Facebook
  • LinkedIn
  • Pinterest
  • WhatsApp
  • Reddit

Related

Contact SAGES

Society of American Gastrointestinal and Endoscopic Surgeons
11300 W. Olympic Blvd Suite 600
Los Angeles, CA 90064 USA
webmaster@sages.org
Tel: (310) 437-0544

Find Us Around the Web!

  • Facebook
  • Twitter
  • YouTube

Important Links

SAGES 2023 Meeting Information

Healthy Sooner: Patient Information

SAGES Guidelines, Statements, & Standards of Practice

SAGES Manuals

 

  • taTME Study Info
  • Foundation
  • SAGES.TV
  • MyCME
  • Educational Activities

Copyright © 2023 Society of American Gastrointestinal and Endoscopic Surgeons