• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market

    Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Creganna Medical, part of TE Connectivity

    FUTEK Advanced Sensor Technology Inc.

    K-Tube Technologies

    MW Life Sciences

    Qosina Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Spectrum Plastics Group

    Creganna Medical, part of TE Connectivity

    PTI Engineered Plastics Inc.

    MW Life Sciences

    K-Tube Technologies
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    JenaValve Technology Receives FDA Approval for Expanding its IDE Feasibility Studies

    Trials to examine efficacy of treatment with Pericardial TAVR System with the Everdur transcatheter heart valve and Coronatix Transfemoral Delivery Catheter.

    Related CONTENT
    • JenaValve Technology Appoints New CEO
    • AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    • FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    • Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    • Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    Business Wire01.18.19
    JenaValve Technology Inc. has announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur transcatheter heart valve (THV) and Coronatix Transfemoral Delivery Catheter. The approval expands eligible patient enrollment from 20 patients at extreme or high surgical risk (10 aortic stenosis [AS], 10 aortic regurgitation [AR]) to 80 patients at extreme or high surgical risk (40 AS, 40 AR) at up to 10 U.S. sites.
     
    The prospective IDE studies are part of a larger, ongoing CE Mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers of excellence in Europe and New Zealand.
     
    The JenaValve system is proprietary and differentiated from currently available TAVR devices due to the Everdur THV locator-based technology, designed to enable anatomically-correct, predictable implantation using the new 18-Fr equivalent Coronatix Transfemoral Delivery Catheter. Enrollment has been completed for the AS CE Mark clinical program and is ongoing for the AR CE Mark clinical program.
     
    “We were the first to perform this procedure in the U.S., and have been impressed with the performance of both the delivery system and the valve. We, along with our colleagues at MedStar Washington Hospital Center, conducted the initial U.S. clinical cases in patients with both AS and AR, and believe that those results warrant expanded investigation of the system in the United States," said Dr. Martin Leon, executive chairman of the JenaValve Clinical Development Program, director of the Center for Interventional Vascular Therapy, and professor of Medicine at Columbia University Medical Center. "We are especially encouraged by the JenaValve TAVR technology in the minimally invasive treatment of eligible patients with severe AR who are at increased surgical risk. That group of patients, until now, have been wihout a suitable transcatheter option in the U.S. We look forward to welcoming the new sites and physicians into the studies, and continuing to study the versatility and durability of the JenaValve implants.”

    JenaValve is currently seeking CE Mark approval for the treatment of patients with symptomatic, severe aortic stenosis, and anticipates commercializing the system in select countries and sites in 1H 2019.
     
    “We are extremely pleased with the initial clinical results, and are grateful to the U.S. physicians who made these trials possible as they seek a less invasive approach for these patient populations,” said JenaValve CEO Victoria Carr-Brendel, Ph.D. “The device continues to demonstrate exceptional hemodynamics and best-in-class perivalvular leakage results with low pacemaker rates. We are all encouraged by the FDA’s approval to expand this U.S. clinical program and look forward to furthering our partnership with clinical leaders in the United States.”
     
    The JenaValve Pericardial TAVR System consists of the Everdur Pericardial Aortic Valve (manufactured at the JenaValve facility in the United Kingdom) and the Transfemoral Delivery System. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The Coronatix transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach with anatomic positioning over the native valve. The System is available in three sizes intended for aortic annulus diameters from 21mm to 27mm. A larger bioprosthesis size is in development. The JenaValve Pericardial TAVR System is an investigational device in the United States and internationally.
     
    JenaValve Technology Inc., with locations in Irvine, Calif.; Leeds, U.K.; and Munich, Germany; develops, manufactures, and markets transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. The company is in clinical development of its next-generation transfemoral TAVR system, consisting of the Everdur valve and Coronatix transfemoral delivery catheter, in both the United States and CE Mark countries for treating patients with aortic stenosis and/or aortic regurgitation. JenaValve is backed by U.S., European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (a Euronext-listed investment company), Legend Capital, NeoMed Management, Omega Funds, RMM, Valiance Life Sciences and VI Partners.
    Related Searches
    • fda approval
    • technology
    • forward
    • ce mark
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    JenaValve Technology Appoints New CEO JenaValve Technology Appoints New CEO
    AWAK AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    FDA FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    Mike on Medtech: Holiday Wish List, Part 1 Mike on Medtech: Holiday Wish List, Part 1
    FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns
    New Efforts to Strengthen FDA’s Expanded Access Program New Efforts to Strengthen FDA’s Expanded Access Program
    FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats
    FDA Approves New DNA-Based Test to Determine Blood Compatibility FDA Approves New DNA-Based Test to Determine Blood Compatibility
    Bose Bose's Self-Fitting, User-Controlled Hearing Aid Wins FDA Nod
    JenaValve Technology Implants Initial Patients With Next-Generation TAVR System JenaValve Technology Implants Initial Patients With Next-Generation TAVR System

    Related Breaking News

    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21

    • Cardiovascular
      RSIP Vision Announces New Coronary Artery Segmentation Tool

      RSIP Vision Announces New Coronary Artery Segmentation Tool

      New module utilizes deep learning algorithms combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Charles Sternberg, Assistant Editor 02.18.21


    • Cardiovascular
      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Technology approved to treat calcified coronary plaque.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular
      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Informs physicians to cease use of the device until further notice.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21


    • Cardiovascular
      Vascular Perfusion Solutions

      Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status

      Enables preserving of vascularized tissue for eight hours.
      Sam Brusco, Associate Editor 02.09.21

    • Cardiovascular
      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.
      Michael Barbella, Managing Editor 02.08.21

    • Cardiovascular
      FDA Clears Wearable Electrocardiogram Sensor

      FDA Clears Wearable Electrocardiogram Sensor

      The product offers extended ambulatory ECG recording up to three weeks.
      Michael Barbella, Managing Editor 02.08.21


    • Cardiovascular | Surgical
      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      There were no incidences of structural valve deterioration at the five-year mark.
      Sam Brusco, Associate Editor 02.01.21

    • Cardiovascular
      Medtronic Expands Release of Radial Artery Access Portfolio

      Medtronic Expands Release of Radial Artery Access Portfolio

      Completes first-in-patient procedure with newly acquired catheters.
      Charles Sternberg, Assistant Editor 02.01.21

    • Cardiovascular
      Medtronic

      Medtronic's DiamondTemp Ablation System Gains FDA Approval

      Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.
      Sam Brusco, Associate Editor 01.29.21


    • Cardiovascular | Diagnostics
      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      3D ultrasound integrated with software for breakthrough in surveillance of abdominal aortic aneurysms.
      Sam Brusco, Associate Editor 01.28.21

    • Cardiovascular | Surgical
      Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

      Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

      UBC Okanagan research could transform the current gold standard for heart valves.
      Sam Brusco, Associate Editor 01.27.21

    • Cardiovascular
      Alleviant

      Alleviant's Transcatheter Tech Obtains Breakthrough Status

      The technology offers a no-implant interatrial shunt therapy for heart failure patients.
      Sam Brusco, Associate Editor 01.25.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Approves Daytime Treatment For Sleep Apnea And Snoring
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    • Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    New FDA Traceability Rule Appears to Omit Dietary Supplement Manufacturers
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Verescence Acquires Majority Stake in Pacificglas
    Happi

    Latest Breaking News From Happi

    GUM Recalls Oral Spray
    Sephora To Open More Stores in 2021
    Clean Beauty Collective Supports Earth Day Initiative
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    CEC expands into labels and packaging with Heidelberg
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login