• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Etched Nanopillars Kill Bacteria, Fungi on Titanium Implants

      Etched Nanopillars Kill Bacteria, Fungi on Titanium Implants

      Cells Release Insulin in Response to Music

      Cells Release Insulin in Response to Music

      Microneedle Skin Patch Measures Cancer Biomarkers

      Microneedle Skin Patch Measures Cancer Biomarkers

      Enzyme Treatment Strips Mucins from Cancer Cells

      Enzyme Treatment Strips Mucins from Cancer Cells

    • Radiology
      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Portable and Radiation-Free Imaging with Magnetic Nanoparticles

      Imaging Technique Reveals Living Brain Tissue in its Complexity

      Imaging Technique Reveals Living Brain Tissue in its Complexity

      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

    • Cardiology
      Ultrasound-Equipped Bra Monitors for Breast Cancer

      Ultrasound-Equipped Bra Monitors for Breast Cancer

      3D Printed Heart Muscle Beats

      3D Printed Heart Muscle Beats

      Wireless Patch Monitors, Paces Heart and then Biodegrades

      Wireless Patch Monitors, Paces Heart and then Biodegrades

      Photonic Radar Monitors Breathing from a Distance

      Photonic Radar Monitors Breathing from a Distance

    • Surgery
      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Highly Precise Pressure Sensor for Laparoscopic or Robotic Surgical Tools

      Highly Precise Pressure Sensor for Laparoscopic or Robotic Surgical Tools

      Magnetic Tentacle Robots for Minimally Invasive Procedures

      Magnetic Tentacle Robots for Minimally Invasive Procedures

      Artificial Muscle Changes Stiffness with Voltage

      Artificial Muscle Changes Stiffness with Voltage

    • Nanomedicine
      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Nanorobots Release Reactive Oxygen Species to Kill Fungal Biofilms

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Growth Factor-Loaded Microparticles Enhance 3D Bioprinted Muscle

      Brain Computer Interface Decodes Speech and Facial Expressions

      Brain Computer Interface Decodes Speech and Facial Expressions

      Semi-Automated Manufacture of E-Skin Sensors

      Semi-Automated Manufacture of E-Skin Sensors

      Above Elbow Amputee Controls Individual Bionic Fingers

      Above Elbow Amputee Controls Individual Bionic Fingers

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

Obalon Non-Surgical Weight Loss System: Interview with Andy Rasdal, CEO of Obalon Therapeutics.

November 29th, 2016 Conn Hastings Exclusive, GI, Medicine

obalon

Medgadget recently reported on the FDA approval of the Obalon balloon system, which assists weight-loss in obese patients who have failed to lose weight by other means and is an alternative to conventional gastric bypass surgery. The system has been developed by Obalon Therapeutics, a company out of Carlsbad, California, and consists of inflatable balloons that can be inserted into the stomach in a minimally invasive manner. The treatment involves swallowing a deflated balloon in the form of a small capsule attached to a thin tube. Once in the stomach, the balloon is inflated and the tube is withdrawn. A maximum of up to three balloons can be placed in the stomach, to be left in place for up to six months before deflation and removal using an endoscopic procedure. The balloons contribute a feeling of satiety, meaning that patients tend to eat less and lose weight.

Medgadget had the opportunity to ask Andy Rasdal, CEO of Obalon Therapeutics some questions about the Obalon balloon system.

 

Conn Hastings, Medgadget: Congratulations on the recent FDA approval of the Obalon system. Can you give us a brief overview as to how the system compares with other treatments for obese patients?

balloonAndy Rasdal, Obalon Therapeutics: Thank you. The FDA PMA approval of the Obalon Balloon System came only after rigorous FDA review and the successful completion of a double-blinded, randomized, sham-controlled trial that met its co-primary weight loss endpoints and demonstrated a strong safety profile. The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise.

The Obalon Balloon is a very different technology platform than the other two gastric balloons currently approved in the U.S. – the ReShape Duo and the Apollo Orbera. For ReShape and Apollo, a single balloon is placed in the stomach via an endoscopic procedure under anesthesia and filled with liquid. In contra st, the Obalon Balloon is swallowed in a dissolvable capsule without the need for anesthesia and filled with gas. Up to three balloons may be swallowed and placed during the therapy period. At Obalon, our design intent was to create a gastric balloon that minimized side effects and provided progressive weight loss over the full six-month treatment period.

 

Medgadget: Gastric bypass surgery produces a permanent change in the architecture of the gastrointestinal tract, whereas the balloon system is removed after 6 months. Is there a risk that patients could regain weight once the system is removed, or do lasting changes in lifestyle occur?

Andy Rasdal: We studied that in our U.S. Pivotal Trial that support FDA approval and the data was presented on November 4, 2014 by Dr. Aurora Pryor in a scientific session at Obesity Week. Dr. Pryor presented that at the end of one year, six months after the balloons were removed, patients had maintained 89.5% of their weight loss on average.

 

Medgadget: How was the balloon system conceived?

Andy Rasdal: We started Obalon more than eight years ago with the intent to invent a novel, non-surgical and fully reversible device that would give overweight and obese people a safe and effective option to reverse the progress of this chronic disease. Obalon did not invent the idea of a space-occupying device for weight loss, or even concept the gastric balloon, but Obalon has invented the first and only swallowable, gas-filled balloon approved by the FDA.

The Obalon Balloon is intended to occupy space in the stomach to make patients feel full sooner, eat less and lose weight. In addition to the strong safety and efficacy demonstrated in our US Pivotal Trial that supported our FDA approval, we believe the Obalon Balloon offers many important ease-of-use advantages over prior and current gastric balloons to both providers and patients.

First, by being swallowable, the Obalon Balloon is easy to place – a patient simply swallows the capsule with the balloon inside without anesthesia or sedation. Placement does not require an endoscopic procedure under anesthesia like other gastric balloons. The simple placement enables balloon volume to be increased incrementally over the treatment period by simply swallowing up to two more additional balloon capsules, which is intended to minimize side effects and create progressive weight loss over the full treatment period.

Next, by being gas-filled, the balloon is light and floats up in the fundus, or top of the stomach, as opposed to sinking to the antrum, or bottom of the stomach, like other prior and current gastric balloons. This is intended to be less offensive to the stomach to increase patient comfort and reduce the adverse events seen with conventional liquid-filled balloons.

Creating a swallowable, gas-filled balloon required the invention of first of its kind technology. Our multi-layer balloon film is thin enough to fit into a swallowable capsule, but robust enough to withstand the chemical and mechanical forces of the stomach trying to digest it. Our balloon is filled with a proprietary mix of gas, which along with a novel inflation valve, ensure full balloon inflation throughout the full six-month treatment period. Finally, we have developed unique capsule and catheter technology that enables the balloon to be reliably delivered to and inflated in the stomach.

 

Medgadget: Are the balloons well tolerated? This sounds like a procedure with much less morbidity and risk than a gastric bypass. Is that a fair assessment?

In the U.S. Pivotal Trial, there was only a single serious adverse event (0.3% of patients) that was related to a patient who took contraindicated anticoagulants after outpatient knee replacement surgery during the trial. Overall, the Obalon Balloon was very well tolerated and more than 80% of all adverse events were rated as mild.

 

Medgadget: The system reduces hunger by producing a feeling of fullness in the stomach when food is consumed. Is this the primary consideration in hunger, or do other factors like blood sugar levels or psychological issues also play a role?

Andy Rasdal: The mechanism of weight loss, especially related to the different modalities, is a complex interaction of both physiological and psychological factors. I believe the simplest explanation of how the Obalon Balloon works is that its intended to occupy space in the stomach to make patients feel full sooner, eat less and lose weight. It is not a magic pill and requires the patient to make behavioral changes, hopefully as part of a structured diet and exercise program provided in conjunction with the balloon therapy.

 

Medgadget: Can a second round of balloon treatment be implemented, if required?

Andy Rasdal: Obalon has not studied the safety and efficacy of successive balloon treatments at this time, so we cannot comment scientifically.

divider

Product page: Obalon Balloon System…

Conn Hastings

Conn Hastings received a PhD from the Royal College of Surgeons in Ireland for his work in drug delivery, investigating the potential of injectable hydrogels to deliver cells, drugs and nanoparticles in the treatment of cancer and cardiovascular diseases. After achieving his PhD and completing a year of postdoctoral research, Conn pursued a career in academic publishing, before becoming a full-time science writer and editor, combining his experience within the biomedical sciences with his passion for written communication.

Sponsored

Viral Vector Manufacturing in Gene Therapy and Vaccine Development

Health and Clean Air: Why Indoor Ventilation Matters

Health and Clean Air: Why Indoor Ventilation Matters

New Survey Finds Strong Consumer Preference for More Natural Hernia Repair Options

MedTech Outlook 2023 for Latin America Released

MedTech Outlook 2023 for Latin America Released

Packaging Compliance Labs (PCL) Celebrates Site Expansion in Grand Rapids, MI

interviews & reviews
UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

UV-Free Air Decontamination: Interview with Sorel Rothschild, VP at Quantum Innovations

EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

EarliPoint Evaluation System for ASD Diagnosis: Interview with Tom Ressemann, CEO of EarliTec Dx

Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

Visually Guided Uterine Biopsies in Physician’s Office: Interview with Allison London Brown, CEO of LUMINELLE

AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro

AI-Powered Pain Relief: Interview with Claire Smith, VP at Nevro

MISHA Knee Shock Absorber: Interview with Anton Clifford, CEO of Moximed

MISHA Knee Shock Absorber: Interview with Anton Clifford, CEO of Moximed

Shelf-Stable Breast Milk Powder: Interview with Dr. Vansh Langer, CEO at BBy

Shelf-Stable Breast Milk Powder: Interview with Dr. Vansh Langer, CEO at BBy

"We Are Electric" by Sally Adee: Medgadget Interviews the Author

"We Are Electric" by Sally Adee: Medgadget Interviews the Author

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email