• 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
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    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
    EchoNous Expands Its Kosmos Hardware Platform

    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020

    Bio-Techne to Acquire Asuragen for $320M

    QUANTA Appoints Chief Operating Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform

    Diagnostic Desperation: A Look at IVD Trends During COVID-19

    Resourceful Resources: Materials Make a Difference During the Pandemic

    Stressed Testing: Challenges with Medical Device Testing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cybersecurity Compromises, Courtesy of COVID-19

    A Look at the Actual Device Costs for Hospitals

    Show Time: Here’s What a Year of No Tradeshows Meant for Small Businesses

    FDA Making Progress With Technology and Data Action Plans

    What’s Hot Now in Medtech M&A
    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
    PTI Engineered Plastics Inc.

    maxon

    Medicoil

    Forefront Medical Technology

    Creganna Medical, part of TE Connectivity
    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
    Forefront Medical Technology

    maxon

    Medicoil

    Medbio LLC

    Qosina Corp.
    • 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

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

    Technology approved to treat calcified coronary plaque.

    Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter. Image courtesy of Shockwave Medical.
    Related CONTENT
    • Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation
    • EchoNous Expands Its Kosmos Hardware Platform
    • The Many Hats of an Integrated Contract Manufacturer
    • Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    • NAMSA Acquires American Preclinical Services
    Charles Sternberg, Assistant Editor02.17.21
    Shockwave Medical Inc.’s sonic pressure wave therapy has received Pre-Market Approval for severely calcified coronary artery disease from the U.S. Food and Drug Administration (FDA).
     
    The technology, which was granted Breakthrough Device designation by the FDA, is a novel application of lithotripsy, an approach that has been used for decades to safely break up kidney stones. With this approval, IVL is now commercially available in the United States to treat problematic calcium in the coronary arteries, which can reduce blood flow in the heart.
     
    As coronary artery disease progresses, plaque in the arterial wall often evolves into calcium deposits, which narrow the artery and restrict blood flow. These bone-like structures make the artery rigid and more difficult to reopen with conventional treatments including balloons, which attempt to crack the calcium when inflated to high pressure, and atherectomy, which drills through the calcium to open the artery. While atherectomy has been available for several decades, its use remains low, despite the high prevalence of calcium, due to its complexity of use and potential to result in adverse patient outcomes.
     
    How the Technology Works
    Intravascular Lithotripsy uses sonic pressure waves, also known as shockwaves, that pass through soft arterial tissue and preferentially disrupt calcified plaque by creating a series of micro-fractures. After the calcium has been cracked, the artery can be expanded at low pressure and a stent safely implanted to improve blood flow, with minimal trauma to normal arterial tissue. The coronary technology has been widely adopted internationally and is now available in 50 countries, with more than 25,000 patients successfully treated since the initial commercial availability in early 2018.
     
    “Coronary calcification is a major challenge for physicians because it limits the success of coronary angioplasty procedures and our current tools for addressing calcium have limitations,” said Dean Kereiakes, M.D., FACC, FSCAI, president of The Christ Hospital Heart and Vascular Institute, professor of Clinical Medicine, The Ohio State University, and the co-principal investigator of the pivotal Disrupt CAD III U.S. study. “This approval represents a major advance in both the safety and simplicity of some of our most challenging procedures – and potentially promises to become a new standard of care.”
     
    Relevant Study
    The approval comes on the heels of its U.S. pivotal study recently published in the Journal of the American College of Cardiology (JACC), which confirmed that coronary IVL met both the primary safety and effectiveness endpoints with a low rate of major adverse events and a high rate of procedural success.
     
    Notably, coronary IVL was simple to use and demonstrated a low risk of rare but life-threatening complications that have been associated with the use of high-pressure balloons and atherectomy technologies, including tears in the artery, abrupt arterial closure and a sudden stop of blood flow.
     
    “Obtaining FDA approval for this transformational technology marks a significant advance in the treatment of patients with calcified coronary lesions, and is the culmination of years of technical research, rigorous clinical studies and key learnings from our real-world global experience,” said Doug Godshall, president and chief executive officer of Shockwave Medical. “We are eager for U.S. cardiologists to have access to this technology and experience how a safe, efficient and predictable calcium modification strategy can positively impact their clinical outcomes.”
     
    The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting in the United States. The technology has been cleared for the treatment of peripheral arterial disease in the United States since 2016.
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation Requirements and Impact of the New Guideline- ISO 10993-23: Tests for Irritation
    EchoNous Expands Its Kosmos Hardware Platform EchoNous Expands Its Kosmos Hardware Platform
    The Many Hats of an  Integrated Contract Manufacturer The Many Hats of an Integrated Contract Manufacturer
    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    NAMSA Acquires American Preclinical Services NAMSA Acquires American Preclinical Services
    Memic Receives FDA Marketing Authorization for Hominis Memic Receives FDA Marketing Authorization for Hominis
    Varian CEO to Retire Following Siemens Healthineers Acquisition Varian CEO to Retire Following Siemens Healthineers Acquisition
    Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz
    FDA Breakthrough Device Designation Awarded to BrainCool AB FDA Breakthrough Device Designation Awarded to BrainCool AB's Cooral System
    Hologic Buys Molecular Dx Firm Diagenode for $159M Hologic Buys Molecular Dx Firm Diagenode for $159M
    Solid Growth Forecast for Japan Solid Growth Forecast for Japan's MI Neurosurgical Devices Market
    Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid
    Axonics Buys Contura to Expand to Stress Urinary Incontinence Axonics Buys Contura to Expand to Stress Urinary Incontinence
    Mike on Medtech: Update on FDA Mike on Medtech: Update on FDA's STeP Designation
    FDA Clears Ava Fertility Tracking Wearable Device FDA Clears Ava Fertility Tracking Wearable Device

    Related Breaking News

    • Cardiovascular
      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib

      Will evaluate PulseSelect's pulsed electrical fields to interrupt irregular heart rhythms.
      Sam Brusco, Associate Editor 03.04.21

    • 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

    • 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
      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


    Trending
    • Philips, Disney Join Forces To Reduce Childrens' MRI Anxiety
    • Plastikos Medical Begins Phase II Of Expansion
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • NAMSA Acquires American Preclinical Services
    • Ready Robotics Hires Proven Automation Leaders
    Breaking News
    • EchoNous Expands Its Kosmos Hardware Platform
    • Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    • Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    • Bio-Techne to Acquire Asuragen for $320M
    • QUANTA Appoints Chief Operating Officer
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Stressed Testing: Challenges with Medical Device Testing
    • Resourceful Resources: Materials Make a Difference During the Pandemic
    • Diagnostic Desperation: A Look at IVD Trends During COVID-19
    • Digitize Your QMS via an Enterprise Cloud Platform
    • Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts
    • 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

    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Statins May Contribute to Vascular Calcification by Inhibiting Vitamin K-Dependent Proteins
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies Adds Benjamin Woeste as Territory Sales Manager
    Maroon Group Acquires Cary Company's Raw Materials, Specialty Chemicals Distribution Business
    Matt Fogel Named Mule-Hide's Territory Manager – Southern Virginia
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Expands Its Kosmos Hardware Platform
    Medtronic Begins Trial to Assess Novel Ablation Tech to Treat AFib
    Europe's Cross-Border Medtech Deal Activity Rises in Q4 2020
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Amgen to Acquire Five Prime Therapeutics for $1.9B
    Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    CureVac, Novartis Ink COVID Vax Mfg. Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Estée Lauder Establishes Equity and Engagement Center of Excellence
    L'Oreal On How It Will Shape Beauty's Future at Today's Transparency Summit
    C.O. Bigelow Earns Praise as NYC's Oldest Family-Run Apothecary
    Happi

    Latest Breaking News From Happi

    The Fragrance Foundation Celebrates Fragrance Day
    China To End Animal Testing for Imported 'Ordinary' Cosmetics
    Avon Launches Vegan Skin Care Line
    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

    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Springfield Solutions highlights digital label embellishments
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Appoints Managing Director, China and Asia Pacific
    Full-Year Sales Down 12 Percent at Zimmer Biomet
    Lincotek Medical Expands Coatings and Additive Capacity
    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