• 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
    Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety

    FDA OKs Asensus' Senhance for General Surgery

    Boston Scientific to Buy Lumenis' Surgical Biz for $1B

    Medtech M&A Total Deal Value Plummets in Q4 2020

    Dexcom Launches Inaugural Venture Capital Fund
    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
    Five Themes to Watch as Digital Health Takes Center Stage

    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
    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
    Spectrum Plastics Group

    K-Tube Technologies

    Concise Engineering

    MW Life Sciences

    Qosina Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Grant Funding Works and How It Can Help

    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
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Qosina Corp.

    Creganna Medical, part of TE Connectivity

    PTI Engineered Plastics Inc.

    Forefront Medical Technology

    Concise Engineering
    • 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

    FDA Approves Abbott's Xience Sierra Everolimus-Eluting Coronary Stent

    New features help doctors treat more difficult-to-reach blockages in patients' arteries.

    FDA Approves Abbott
    Design innovations in XIENCE Sierra include a thinner profile, increased flexibility, longer lengths, and small diameters. Image courtesy of Abbott.
    Related CONTENT
    • FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    • Medtronic Receives FDA Approval for Expanded MRI Labeling
    • Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
    • Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    • Kardium Receives $115 Million in New Financing for Afib Treatment
    PR Newswire05.23.18
    Abbott today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE Sierra, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of XIENCE include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.1
     
    "We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents."
     
    Design innovations in XIENCE Sierra include a thinner profile, increased flexibility, longer lengths, and small diameters. The new stent and delivery system were specifically developed for the treatment of complex cases, including people with multiple or totally blocked vessels.
     
    More than 8 million people worldwide have received a XIENCE stent since its initial regulatory approvals in the EU in 2006 and in the U.S. in 2008. Its unparalleled safety is supported in over 100 clinical trials and by 10 years of global real-world experience.2
     
    Abbott received Regulatory approval for XIENCE Sierra in Japan in April 2018, and CE mark in Europe in October 2017.
     
    References
    1 Decision Resources Group, July 2017. Data on file at Abbott.
    2 10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element, Promus Element Plus, Promus Premier, Synergy); MDT stents (Resolute, Resolute Integrity, Resolute Onyx); Terumo stents (Nobori, Ultimaster); Biotronik stent (Orsiro); and Biosensors stent (BioMatrix). Data on file at Abbott Vascular.  
    Related Searches
    • it
    • technology
    • vice president
    • clinical trials
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    FDA Approves Daytime Treatment for Sleep Apnea and Snoring FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    Medtronic Receives FDA Approval for Expanded MRI Labeling Medtronic Receives FDA Approval for Expanded MRI Labeling
    Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production
    Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    Kardium Receives $115 Million in New Financing for Afib Treatment Kardium Receives $115 Million in New Financing for Afib Treatment
    J&J Granted FDA Approval for Monofocal IOL J&J Granted FDA Approval for Monofocal IOL
    Medtronic Medtronic's DiamondTemp Ablation System Gains FDA Approval
    Boston Scientific Boston Scientific's Vercise Genus DBS Earns FDA Approval
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    Preparing Your Design Controls for FDA Approval Preparing Your Design Controls for FDA Approval
    The Big Challenges of Medical Device Miniaturization The Big Challenges of Medical Device Miniaturization
    How Design Controls Can Prevent Medical Device Recalls How Design Controls Can Prevent Medical Device Recalls
    Novocure Earns CE Mark for NovoTTF-100L System Novocure Earns CE Mark for NovoTTF-100L System
    HeartHero Inc. Awarded ISO 13485 Certification HeartHero Inc. Awarded ISO 13485 Certification
    The Heart of the Matter: Trends in Cardiology The Heart of the Matter: Trends in Cardiology

    Related Breaking News

    • Surgical
      FDA OKs Asensus

      FDA OKs Asensus' Senhance for General Surgery

      Indication expansion allows Senhance's use in high-value, complex reconstructive surgeries.
      Sam Brusco, Associate Editor 03.03.21

    • Surgical
      Boston Scientific to Buy Lumenis

      Boston Scientific to Buy Lumenis' Surgical Biz for $1B

      Gains laser systems, fibers, and accessories for urology and otolaryngology procedures.
      Sam Brusco, Associate Editor 03.03.21

    • Surgical
      Memic Receives FDA Marketing Authorization for Hominis

      Memic Receives FDA Marketing Authorization for Hominis

      Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.
      Charles Sternberg, Assistant Editor 03.02.21


    • Surgical
      Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

      Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

      Medi-Tate's iTind nitinol implant supports lower urinary tract symptom relief due to benign prostatic hyperplasia.
      Sam Brusco, Associate Editor 03.02.21

    • Cardiovascular
      Soundbite Medical Wins Health Canada Approval for PAD Treatment

      Soundbite Medical Wins Health Canada Approval for PAD Treatment

      Product targets patients with heavily calcified chronic total occlusions.
      Michael Barbella, Managing Editor 03.02.21

    • Cardiovascular
      Novel Heart Failure Treatment Technology Scores Positive Trial Results

      Novel Heart Failure Treatment Technology Scores Positive Trial Results

      All patients treated with Vascular Dynamics' MobiusHD Device showed improvement.
      Michael Barbella, Managing Editor 03.01.21


    • 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

    • Surgical
      TransEnterix Changes Name to Asensus Surgical

      TransEnterix Changes Name to Asensus Surgical

      The rebranded firm also introduced a new surgical category—performance-guided surgery.
      Sam Brusco, Associate Editor 02.24.21

    • 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


    • Surgical
      FDA Green Lights EPI

      FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding

      Rapidly and reliably controls bleeding during GI procedures.
      Sam Brusco, Associate Editor 02.23.21

    • 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


    Trending
    • FDA Breakthrough Device Designation Awarded To BrainCool AB's Cooral System
    • Mike On Medtech: Update On FDA's STeP Designation
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Quidel's QuickVue At-Home COVID-19 Test Earns EUA
    • NAMSA Acquires American Preclinical Services
    Breaking News
    • Ready Robotics Hires Proven Automation Leaders
    • Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety
    • FDA OKs Asensus' Senhance for General Surgery
    • Boston Scientific to Buy Lumenis' Surgical Biz for $1B
    • Medtech M&A Total Deal Value Plummets in Q4 2020
    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

    Study Explains Link Between Probiotic Strains and Children’s Immune Health Benefits
    Maypro Launches Brain Heatlh Ingredient NeuroHD
    Gadot Biochemical Launches New Magnesium Ingredients
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Matt Fogel Named Mule-Hide's Territory Manager – Southern Virginia
    Benjamin Moore Launches COMMAND
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Ready Robotics Hires Proven Automation Leaders
    Philips, Disney Join Forces to Reduce Childrens' MRI Anxiety
    FDA OKs Asensus' Senhance for General Surgery
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Innoforce and dMed Enter Development Collaboration
    Matica Biotechnology Breaks Ground on Cell and Gene Therapy Site
    Four Female Leaders Appointed to Cell & Gene CDMO
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    BizBash Names Unfiltered Experience ‘People's Choice: Best Influencer Event’
    P&G Makes Progress Toward Packaging Circularity in Europe
    Coty Partners with LanzaTech to Introduce Sustainable Ethanol
    Happi

    Latest Breaking News From Happi

    Uoma Beauty Unveils a Coming 2 America Makeup Collaboration
    Coty Partners with LanzaTech to Reduce Its Environmental Impact
    Waterless Beauty, Simplified Routines Shape Clean Beauty at Whole Foods
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Ashland announces PSA price hike in North America
    Arrow Systems and Sihl form flexible packaging partnership
    Flint Group Packaging announces global price increase
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Joa Announces Expandable Absorbent Core Wrap Solution
    Principle Business Enterprises Celebrates 60 Years
    Mann+Hummel Invests in Pamlico Air
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Lincotek Medical Expands Coatings and Additive Capacity
    Spinal Elements Relaunches the Luna XD and Orbit Systems
    Coronavirus Triggers Double-Digit Revenue Dropoff at Smith+Nephew
    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