• Resources
  • Blog
  • Journalists
  • Log In
  • Sign Up
  • Data Privacy
  • Send a Release
Cision PR Newswire: news distribution, targeting and monitoring home
  • News
  • Products
    • Overview
    • Distribution by PR Newswire
    • Cision Communications Cloud®
    • Cision IR
    • All Products
  • Contact
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases
      • All News Releases
      • All Public Company
      • English-only


      • News Releases Overview
      • Multimedia Gallery
      • All Multimedia
      • All Photos
      • All Videos


      • Multimedia Gallery Overview
      • Trending Topics
      • All Trending Topics


  • Business & Money
      • Auto & Transportation
      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation


      • Auto & Transportation Overview
      • Business Technology
      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors


      • Business Technology Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Financial Services & Investing
      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Stock Offering
      • Stock Split
      • Venture Capital


      • Financial Services & Investing Overview
      • General Business
      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News


      • General Business Overview
  • Science & Tech
      • Consumer Technology
      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications


      • Consumer Technology Overview
      • Energy & Natural Resources
      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities


      • Energy & Natural Resources Overview
      • Environ­ment
      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


      • Environ­ment Overview
      • Heavy Industry & Manufacturing
      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco


      • Heavy Industry & Manufacturing Overview
      • Telecomm­unications
      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications


      • Telecomm­unications Overview
  • Lifestyle & Health
      • Consumer Products & Retail
      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys


      • Consumer Products & Retail Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Health
      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine


      • Health Overview
      • Sports
      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories


      • Sports Overview
      • Travel
      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry


      • Travel Overview
  • Policy & Public Interest
      • Policy & Public Interest
      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy


      • Policy & Public Interest Overview
  • People & Culture
      • People & Culture
      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • People & Culture Overview
      • In-Language News

      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO

      Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • Overview
  • Distribution by PR Newswire
  • Cision Communications Cloud®
  • Cision IR
  • All Products
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR
  • General Inquiries
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Log In
  • Resources
  • Blog
  • Journalists
  • RSS
  • GDPR

Late-Breaking Clinical Trial Data Presented from Mercator MedSystems' DANCE Trial at VIVA

First Large-Scale Trial of the Bullfrog Micro-Infusion Device with Dexamethasone Shows Positive Results


News provided by

Mercator MedSystems

Sep 21, 2016, 12:22 ET

Share this article

Share this article


EMERYVILLE, Calif., Sept. 21, 2016 /PRNewswire/ -- Mercator MedSystems today announced that Christopher Owens, MD, MSc, Associate Professor of Surgery in the Division of Vascular and Endovascular Surgery at the University of California, San Francisco (UCSF), presented 13-month data from the DANCE trial during a late-breaking scientific session at the Vascular Interventional Advances (VIVA) Annual Conference 2016 in Las Vegas, Nevada. DANCE is a prospective, multicenter, single-arm study designed to assess the clinical performance of the localized delivery of a generic steroid, dexamethasone, to the tissues around arteries that have been injured during endovascular interventions, using Mercator's proprietary Bullfrog® Micro-Infusion Device.

Thirteen-month results from 281 patients that received the local dexamethasone therapy were presented. Data were separated into two treatment populations: the complete data set for 157 patients undergoing atherectomy as their primary therapy; and interim data for 124 patients undergoing angioplasty as the primary therapy. For the atherectomy group, the primary safety endpoint revealed no post-operative death and 2.4% major adverse limb events, and the primary efficacy endpoint of primary patency was 83.8% at 12 months and 80.2% at 13 months. Primary patency was defined as the lack of target lesion revascularization (TLR) or narrowing detected by a duplex ultrasound peak systolic velocity ratio (PSVR) greater than 2.4. Freedom from TLR was 89.7% at 12 months and 88.8% at 13 months in the atherectomy group.

According to Dr. Owens, "The adventitial drug delivery of dexamethasone, or ADD-DEX, procedure using the Bullfrog Micro-Infusion Device in the DANCE trial has produced promising patency, a very low TLR, and an exemplary safety and device performance record. These data, in my opinion, warrant a paradigm shift toward an anti-inflammatory and pro-resolution strategy for restenosis. The message is clear and simple: an inflammatory process, like what we know we create when we open an artery, requires an anti-inflammatory remedy."

The data presented by Dr. Owens compares favorably to published data on drug-coated balloons (DCBs), which are expected to be used in 22% of peripheral cases in 2017, according to a survey conducted by RBC Capital Markets. "What we have accomplished with this study is dramatically different from prior drug delivery in the periphery," noted Dr. Owens. "Until now, drug-coated balloons have incorporated drugs that were designed to fight cancer. We are now showing that if we control the potent local inflammation created when we open the vessel by atherectomy or angioplasty, we can see a similar result in a more challenging cohort of patients."

Mercator Chief Science and Technology Officer, Kirk Seward, PhD, noted, "The use of a microneedle to pinpoint local drug delivery has many advantages over current drug delivery technology. It affords the physician an opportunity to add X-ray-opaque contrast dye and create a visualization of the agent's delivery and the ability to diagnose successful local drug administration. Micro-infusion also allows the physician to deliver varying amounts of drug through one catheter rather than a fixed amount based on the coating dimensions associated with a balloon or stent. Achieving these results with a straightforward, off-the-shelf, low-cost steroid gives us great enthusiasm for what might be possible with other agents. We are also encouraged with the LIMBO studies currently underway, two below-the-knee clinical trials that are using the Bullfrog Micro-Infusion Device to deliver the same drug for patency improvement in critical limb ischemia (CLI) patients."

About the Bullfrog® Micro-Infusion Device
The Mercator Bullfrog Micro-Infusion Device is an FDA 510(k)-cleared and CE-Marked system designed to infuse therapeutic and diagnostic agents directly, non-systemically and safely through blood vessel walls into adventitial tissues. The Bullfrog device is tipped with a balloon-sheathed microneedle, and is compatible with 0.014" guide wires and 5 to 7 Fr introducer sheaths. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection needle as it is guided safely through the vasculature to target vessels with diameters of 2 to 8 mm.

About the DANCE Trial
The Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy after Femoropopliteal Revascularization (DANCE) trial is a first-in-class perivascular drug delivery trial that pairs the Bullfrog Micro-Infusion Device with dexamethasone to treat femoral and popliteal arteries after revascularization. The trial was conducted in 35 centers and its leadership includes co-principal investigators Christopher Owens, MD, MSc, from the University of California, San Francisco, and Mahmood Razavi, MD, from St. Joseph's Hospital in Orange, CA. More information about the DANCE trial is available at https://clinicaltrials.gov/ct2/show/NCT01983449.

About Mercator MedSystems
Mercator MedSystems, Inc. (www.mercatormed.com), based in Emeryville, CA, is a venture-backed, privately held medical technology company delivering innovative, customizable, treatment solutions for intractable problems associated with some of the world's most significant diseases. The company develops catheter-guided micro-infusion systems for targeted delivery of drugs and biologics deep inside the body to treat the root cause of a growing portfolio of medical conditions, including cardiovascular disease, cancer, hypertension and heart disease.

For Media Inquiries:
Lori Rosen
[email protected]
917-553-6808

SOURCE Mercator MedSystems

Related Links

http://www.mercatormed.com

Modal title

    Contact Cision

  • Cision Distribution 888-776-0942
    from 8 AM - 9 PM ET

  • Chat with an Expert
    • General Inquiries
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • Media Inquiries
    • Worldwide Offices

    Products

  • Cision Communication Cloud®
  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • For Small Business
  • All Products

    About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • COVID-19 Resources
  • Accessibility Statement

    • Asia
    • Brazil
    • Canada
    • Czech
    • Denmark
    • Finland
    • France
    • Germany
    • India
    • Israel
    • Italy
    • Mexico
    • Middle East
    • Netherlands
    • Norway
    • Poland
    • Portugal
    • Russia
    • Slovakia
    • Spain
    • Sweden
    • United Kingdom

    My Services

  • All New Releases
  • Online Member Center
  • ProfNet

Contact Cision


Products


About


My Services
  • All News Releases
  • Online Member Center
  • ProfNet℠
Cision Distribution Helpline
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2021 Cision US Inc.