• 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
      Flexible Sensors Detect Heavy Metals in Sweat

      Flexible Sensors Detect Heavy Metals in Sweat

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Nanopore Sensor to Study Protein Aggregation in Neurodegeneration

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

    • Radiology
      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Ultrasound Tornado Rapidly Disrupts Blood Clots

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Exciting Medtech at the Healthcareᐩ Expo Taiwan

      Fluorescence Imaging System Illuminates Tumor Depth

      Fluorescence Imaging System Illuminates Tumor Depth

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

      Soft Robot Grows Like a Plant to Travel Through Tight Spaces

    • Cardiology
      Belt Monitors Heart Failure Patients

      Belt Monitors Heart Failure Patients

      Camera Measures Blood Pressure with Quick Look

      Camera Measures Blood Pressure with Quick Look

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Surgery
      Microneedle Bandage for Hemostatic Control

      Microneedle Bandage for Hemostatic Control

      Biobots Use Optogenetic Muscle Actuators for Movement

      Biobots Use Optogenetic Muscle Actuators for Movement

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

    • Nanomedicine
      Extra Hot Nanoparticles for Cancer Therapy

      Extra Hot Nanoparticles for Cancer Therapy

      Making Tumors Tastier for the Immune System

      Making Tumors Tastier for the Immune System

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Improved Membrane Coating for Anti-Cancer Nanoparticles

      Magnetic Bacteria Target Tumors

      Magnetic Bacteria Target Tumors

    • Military Medicine
      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

      Fabric Makes Electricity from Movement to Power Wearables

      Fabric Makes Electricity from Movement to Power Wearables

      Wearable Uses Microneedles to Track Metabolism

      Wearable Uses Microneedles to Track Metabolism

    • Rehab
      Smart Walking Stick for Visually Impaired People

      Smart Walking Stick for Visually Impaired People

      Implantable Device Adheres to Muscle, Treats Atrophy

      Implantable Device Adheres to Muscle, Treats Atrophy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Non-Invasive Spinal Modulation for Cerebral Palsy

      Implanted Magnets for Prosthetic Control

      Implanted Magnets for Prosthetic Control

  • 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

Spiration IBV Bronchial Valve Gets FDA OK

October 28th, 2008 Medgadget Editors Medicine, Thoracic Surgery

IBV™ Valve, the Intra-Bronchial Valve from Spiration, Inc. of Redmond, Washington, has been given Humanitarian Device Exemption (HDE) approval from the FDA “to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged,following lobectomy, segmentectomy, or lung volume reduction surgery.” We’ve been following this device since 2005, and had a report earlier this month on the European approval of this device for precisely the same indications.

“This FDA approval, the first for a lung device in recent memory and the first ever for a bronchial valve, is an exciting milestone and marks an advancement toward broader FDA approval of devices to treat various types of lung conditions,” said Rick Shea, president and CEO, Spiration®. “As one of only three HDE approvals so far in 2008, this approval is a significant accomplishment for Spiration.”
“Although rarely life threatening, prolonged post-operative air leaks can be a significant and costly complication of lung surgery,” said Daniel Sterman, M.D., director of Interventional Pulmonology at the University of Pennsylvania Medical Center in Philadelphia. “The HDE approval of the IBV Valve System will have a positive impact on the lives of patients who are having difficulty recovering from lung surgery. We are pleased that this approval provides a new treatment alternative for these patients.”

Press release: Spiration, Inc. Receives First FDA Approval for Bronchial Valve Humanitarian Device Exemption Allows IBV® Valve System As Minimally Invasive Treatment Alternative for Patients with Prolonged Post-Operative Air Leaks
Product page: IBV Valve
Flashbacks: Spiration IBV Valve Shows Promise in Treatment of Persistent Air Leaks; IBV™ Valve: Intra-Bronchial Device for Emphysema; IBV™ Valve Might Prevent Surgery for Some

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
C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

C-mo Medical Solutions extends seed investment round to €4.8 million to transform cough monitoring

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

New Clarius Power Fan HD3 Delivers a First for Handheld Ultrasound: Continuous Scanning

Fluidx Unveils New Embolic for Neurovascular Use

Fluidx Unveils New Embolic for Neurovascular Use

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

Annalise.ai and Nuance Communications (a Microsoft Company) Announce Key Partnership to Improve Patient Outcomes with Workflow-Integrated AI

PT Genie Unveils New Brand Identity Reflecting Company’s Transformation and Focus on the Global Future of AI and Machine Learning in Digital Healthcare

interviews & reviews
Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Balance Boards to Stay Active in the Offfice: Interview with Joel Heath, CEO of FluidStance 

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Exciting Medtech at the Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Medgadget Visits Healthcareᐩ Expo Taiwan

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical's Greg Mielke

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

Symani Microsurgical Robotic System: Interview with Mark Toland, CEO of Medical Microinstruments

  • 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!
Posting....
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email