• 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

FDA Grants IDE Approval for the Nellix Endovascular Aneurysm Sealing System

December 27th, 2013 Gaurav Radiology, Vascular Surgery

NellixEndologix (Irvine, CA) received an Investigational Device Exemption (IDE) from the FDA to initiate a clinical study to prove the safety and effectiveness of the Nellix Endovascular Aneurysm Sealing System. The clinical study, called EVAS FORWARD-IDE, which will enroll 180 patients at 30 locations in the US, Europe, and Canada, is part of the larger EVAS FORWARD Clinical Program that aims to provide clinical and economic evidence for the Nellix Endovascular Aneurysm Sealing device.

The Nellix device, intended to treat infrarenal abdominal aortic aneurysms (AAA), was engineered as an alternative to endovascular stent grafts in order to treat a wider range of anatomies. The device works on the principle of sealing the aneurysm sac rather than providing a protective conduit through the aneurysm like a stent graft would, and is designed to minimize implant migration, eliminate endoleaks, and preserve patency internal iliac arteries.

The device has two main parts: bilateral stents that pave the blood from the infrarenal segments to legs, and endobags that are inflated with a biostable polymer to seal the aneurysm sac. According to Endologix, some of the inclusion criteria for patients to be enrolled in the EVAS FORWARD-IDE clinical study are as follows:

  • Non-aneurysmal aortic neck length of ≥ 10mm
  • Non-aneurysmal aortic neck diameter of 18 to 32mm
  • Maximum aortic blood flow lumen diameter of ≤ 60mm
  • Common iliac artery diameter of 8 to 35mm

In investigational cases performed in Europe, the Nellix device has shown excellent anatomic fixation at the aortic bifurcation and optimal stability of the filled endobags for the entire length of the device. The device received European CE mark approval in September 2012.

Flashback: Endologix Nellix Endovascular Graft for Abdominal Aortic Aneurysms…

Product page: Nellix EndoVascular Aneurysm Sealing (EVAS) System…

Press release: Endologix Receives IDE Approval for the Nellix(R) EndoVascular Aneurysm Sealing System…

Gaurav

Gaurav Krishnamurthy, PhD is a Senior R&D engineer at a Bay Area based medical device start-up. Gaurav has a strong passion for medical device innovation and is interested in disruptive medical technologies that not only solve an unmet clinical need, but also bring down the cost of healthcare. Gaurav closely follows medical device trends in emerging markets and is fascinated by simple and inexpensive solutions to major healthcare problems. Gaurav earned his PhD and Master's in Mechanical Engineering from Stanford University where he developed state of the art computational models of beating heart valves that can be used to design and test heart valve prosthetics. Gaurav was a Medtronic BioX Fellow at Stanford University. Gaurav also serves as a Senior Advisor to a Bay Area angel investment group focusing on mobile health and healthcare innovation.

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