• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    TPI Partners with Zeiss

    PPE Moves into New Manufacturing Facility

    Neurent Medical Closes $25 Million Series B Financing

    Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

    FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Concise Engineering

    Medicoil

    Medbio LLC

    Element

    PTI Engineered Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    K-Tube Technologies

    Qosina Corp.

    maxon

    Unicep
    • 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

    Cardiovascular Systems Receives U.S., Japanese Approvals for Diamondback 360 Coronary Micro Crown

    Product is designed to both pilot tight lesions and treat up to 4 mm vessels with a single device.

    Related CONTENT
    • Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial
    • CMS Expedites Breakthrough Device Access; Industry Applauds
    • Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent
    • Vesper Medical Announces First Enrollment in the VIVID Trial
    • Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
    Business Wire04.11.17
    Cardiovascular Systems Inc.'s (CSI) Diamondback 360 Coronary OAS Micro Crown system has been approved in both the United States and Japan for coronary intervention treatment.

    The U.S. Food and Drug Administration (FDA) gave its blessing to the Diamondback 360 to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. In Japan, the device was approved by the country's Ministry of Health, Labor and Welfare (MHLW) as a frontline treatment for de novo severely calcified lesions and to facilitate access to the arteries for percutaneous coronary interventions (PCI) thereafter.

    “We are committed to continued advancement of CSI’s proven OAS technology focused on severe coronary arterial calcium, which is an underserved problem in vascular medicine,” said Scott Ward, chairman, president and CEO of CSI. “Patients with severely calcified coronary lesions are some of the most difficult to treat, leading to worse clinical and economic outcomes. The ORBIT II and COAST studies demonstrated that orbital atherectomy technology is safe and effective in treating patients with severely calcified lesions.”
     
    The Diamondback 360 Coronary OAS Micro Crown retains the novel mechanism of action of the Diamondback 360 Coronary OAS Classic Crown. Both systems allow treatment of multiple vessel sizes with one device while providing continuous flow of blood during treatment, which is important for both acute and long-term success. The OAS Micro Crown is the only device incorporating a diamond-coated tip to immediately engage and pilot through tight, severely calcified lesions that would otherwise be difficult to access, while also treating up to 4mm vessels with the same device. The increased mass of the sanding crown allows for lower rotational speeds, while maintaining the same orbit diameter as the OAS Classic Crown.
     
    “We are excited to receive this approval, which furthers our mission to provide primary tools for the treatment of calcified artery disease and facilitates our first international expansion,” Ward said. “Japan represents an attractive market opportunity as the world’s second-largest market for coronary interventions with over 280,000 PCIs per year, of which 10 percent-20 percent are estimated to be severely calcified. We look forward to working with Medikit, Co. Ltd., our exclusive distribution partner with a large sales force in Japan, to pursue this opportunity.”
     
    Nobufumi Kurita, president of Medikit Co., added, “Heart disease is one of the leading causes of death in Japan. While the prevalence of severely calcified coronary disease is similar to levels in the U.S, it is more readily identified in Japan, given the frequent use of advanced imaging technologies during PCI treatment. We are excited to introduce CSI’s novel OAS Micro Crown to this large and underserved patient population. Our team of coronary sales specialists will initially focus on a limited number of top medical institutions, driving quality adoption in those accounts and preparing for a full commercial launch in calendar 2018.”
     
    COAST was a Harmonization-by-Doing clinical study for the OAS Micro Crown conducted in both the United States and Japan under the regulations of both governments. COAST was led by U.S. National Principal Investigator Gregg W. Stone, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center, New York, N.Y., and Japan National Principal Investigator Dr. Shigeru Saito of Shonan Kamakura General Hospital, Kamakura City, Japan.
     
    CSI’s Diamondback 360 Coronary OAS Classic Crown and Micro Crown are the first and only atherectomy devices approved in the United States to specifically treat severely calcified coronary arteries. Since FDA approval of the OAS Classic Crown in October 2013, more than 25,000 devices have been used to treat patients with CAD. The OAS Micro Crown will supplement the existing OAS Classic Crown product line offering in the United States. A limited release of the OAS Micro Crown is expected to begin in the United States later this summer.
     
    CAD is a life-threatening condition and a leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, severe arterial calcium is present in approximately 12 percent of patients undergoing a percutaneous coronary intervention. Severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events.
     
    Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for treating vascular and coronary disease. The company’s Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. The Stealth 360 Peripheral Orbital Atherectomy System (OAS) received CE Mark in October 2014. To date, more than 290,000 of CSI’s devices have been sold to U.S. institutions.
     
    Established in 1973 and based in Tokyo, Japan, Medikit Co. is a global medical technology company that is publicly-traded on the JASDAQ exchange. Medikit is a market leader in interventional products including vascular access devices such as hemodialysis catheters, intravenous catheters, sheaths and guiding catheters. Medikit products are sold in Japan, the United States and more than 30 other countries. The company has R&D and manufacturing capabilities in Japan and Vietnam with more than 1,300 consolidated employees.
    Related Searches
    • 2013
    • ce mark
    • u.s. food and drug administration
    • imaging
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent Study Shows Lungpacer System Improves Diaphragm Strength by More Than 300 Percent
    Vesper Medical Announces First Enrollment in the VIVID Trial Vesper Medical Announces First Enrollment in the VIVID Trial
    Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe Acutus Medical Launches AcQBlate Force Sensing Ablation System in Europe
    Hologic to Buy Cancer Test Maker Biotheranostics for $230M Hologic to Buy Cancer Test Maker Biotheranostics for $230M
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    Edwards Treats First Patient in Restore Clinical Trial Edwards Treats First Patient in Restore Clinical Trial
    Medtronic Medtronic's OsteoCool Procedure Shows Significant Pain Relief in Cancer Patients
    Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine
    Expert Roundup: Achieving Success in the 2021 Medical Device Landscape Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
    Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon
    RSNA News: Siemens Introduces Cios Flow Mobile C-arm System RSNA News: Siemens Introduces Cios Flow Mobile C-arm System
    GE Healthcare Launches X-ray AI for COVID-19 Patients GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement
    Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing

    Related Breaking News

    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21

    • Cardiovascular | Surgical
      Haemonetics to Acquire Cardiva for Up to $510M

      Haemonetics to Acquire Cardiva for Up to $510M

      Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.
      PR Newswire 01.20.21


    • Cardiovascular | Surgical
      Abbott Wins Expanded Medicare Coverage for MitraClip

      Abbott Wins Expanded Medicare Coverage for MitraClip

      Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.
      Abbott Laboratories 01.20.21

    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21

    • Cardiovascular
      Occlutech

      Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

      First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.
      PR Newswire 01.19.21


    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21

    • Cardiovascular
      FineHeart Successfully Tests Wireless TET System

      FineHeart Successfully Tests Wireless TET System

      A breakthrough in treating patients with severe heart failure.
      FineHeart 01.18.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21


    • Cardiovascular
      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.
      Business Wire 01.13.21

    • Cardiovascular
      Acutus Medical Launches AcQCross Transseptal System in Europe

      Acutus Medical Launches AcQCross Transseptal System in Europe

      The product is designed to improve safety and efficiency in any procedure requiring left heart access.
      Globe Newswire 01.08.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21


    • Cardiovascular
      Edwards Treats First Patient in Restore Clinical Trial

      Edwards Treats First Patient in Restore Clinical Trial

      Evaluates minimally invasive device for mitral valve disease.
      Edwards Lifesciences Corp. 12.21.20

    • Cardiovascular | Diagnostics
      Genetesis

      Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

      Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.
      Business Wire 12.16.20

    • Cardiovascular
      Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

      Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

      Percutaneous transluminal angioplasty balloon procedures declined by almost 30 percent in 2020.
      GlobalData 12.15.20


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Philips Buys Capsule Technologies In $635M Deal
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • TPI Partners with Zeiss
    • PPE Moves into New Manufacturing Facility
    • Neurent Medical Closes $25 Million Series B Financing
    • Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
    • FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TPI Partners with Zeiss
    PPE Moves into New Manufacturing Facility
    Neurent Medical Closes $25 Million Series B Financing
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WDSrx Expands Warehouse Network
    Piramal Inks Clinical Supply Deal with Theratechnologies
    Recipharm Signs Manufacturing Deal with Enzymatica
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Weleda Celebrates 100 Years By 'Opening' Its Gardens
    Happi

    Latest Breaking News From Happi

    NY's 1,4-Dioxane Law May Impact Concentrated Cleaners
    Sabinsa's Top Scientist Addresses US FDA
    Ipsy Adds New Personal Care Brand
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Soma partners with Moore & Moore in US
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Lemu Group Engineers Mask-Making Machine
    Armbrust American Adds Meltblown Manufacturing
    P&G Reports 8% Sales Increase
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Siemens Healthineers’ DR Systems Cleared by FDA
    Former Medtronic Exec Appointed Zimmer Biomet's Chief Transformation Officer
    SeaSpine Launches Regatta Lateral Plates
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    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