• 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
      Cancer Organoids Offer Insights into Treatment Outcomes

      Cancer Organoids Offer Insights into Treatment Outcomes

      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Laser-Based Breath Analysis Detects COVID-19 Infection

      Technique Reveals 3D Genome Interactions

      Technique Reveals 3D Genome Interactions

    • Radiology
      Implanted Ultrasound Lets Chemo Access Brain

      Implanted Ultrasound Lets Chemo Access Brain

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

      RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

    • Cardiology
      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Chest Wearable Provides Key Heart Measurements

      Chest Wearable Provides Key Heart Measurements

      Vein on a Chip Includes Flexible Valves

      Vein on a Chip Includes Flexible Valves

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

    • Surgery
      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Stimulating Wounds with Electricity for Rapid Healing

      Stimulating Wounds with Electricity for Rapid Healing

    • Nanomedicine
      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

      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

    • 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
      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

  • 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

Medtronic’s DBS Therapy for Epilepsy May Yet Get FDA Approval

March 15th, 2010 Medgadget Editors Neurology, Neurosurgery

An FDA advisory panel has voted 7 to 5 in favor of approval of Medtronic’s deep brain stimulation (DBS) device, probably the Soletra, as a treatment option for medically refractory epilepsy in certain patients. The device, already approved for Parkinson’s, was only days earlier reported to have failed an important study goal. Now it is seeing new life, and potential approval, due to a kink in the latest study.
Jennifer Corbett Dooren at the Wall Street Journal explains:

A study of the device was conducted in 110 patients, but it failed to meet a study goal that looked at a reduction in the seizure rate over a three-month period.
However, the FDA said that when looking at just the third month of treatment, patients being treated with the deep-brain-stimulation device had a greater reduction in seizures compared with patients whose device was not activated.
The missed study goal was influenced by one patient who developed a different type of seizure after the device was turned on, both the FDA and Medtronic said. When the device’s power was lowered, the seizures stopped.
Medtronic asked the FDA and the panel to consider the data without the one patient, which would result in the study meeting the three-month goal, or to consider the last month of the three-month period. But the panel was divided on whether the patient should be removed from the analysis of the study.

Wall Street Journal from March 10: Medtronic Brain Stimulator Missed Study Goal
Wall Street Journal from March 12: FDA Panel Backs Device For Epilepsy
Medtronic press release: FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy …
Flashback: Medtronic’s Deep Brain Stimulation Devices Approved for Parkinson’s and Essential Tremor

Medgadget Editors

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.

Sponsored

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

Novel Approach to Assessing Lung Function Enables Improved Detection, Diagnosis and Treatment Decisions in Subject Exposed to Military Burn Pits

U.S. Patent Office Grants Additional Patent Protection For  Exoskeleton Focal-Force Angioplasty Platform

U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

interviews & reviews
Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • 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