Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
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 Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

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

      • 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
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & 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 & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • 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 & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • 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
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

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

      • Telecomm­unications

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

  • Lifestyle & Health
      • Consumer Products & Retail

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

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • 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
      • View All Health

      • Sports

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

      • Travel

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

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • 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
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Abbott Initiates International ABSORB BTK Clinical Trial for Treatment of Below-the-Knee Critical Limb Ischemia


News provided by

Abbott

08 Sep, 2011, 12:00 GMT

Share this article

Share toX

Share this article

Share toX

ABBOTT PARK, Illinois, September 8, 2011 /PRNewswire/ --

-- ABSORB™ is Designed to Treat a Patient's Blocked Vessel and Then Dissolve, Leaving the Vessel Free of a Permanent Metallic Implant

-- The ABSORB BTK Trial Highlights Abbott's Commitment to Developing Innovative Technologies to Advance Endovascular Therapy

Abbott (NYSE: ABT) today announced the initiation of ABSORB BTK, an international clinical trial evaluating the safety and efficacy of the ABSORB™ bioresorbable vascular scaffold (BVS) for the treatment of below-the-knee (BTK) critical limb ischemia. Critical limb ischemia, a severe form of peripheral artery disease (PAD), occurs when blocked vessels impair blood flow to the lower extremities, which can eventually lead to limb amputation. ABSORB restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves within approximately two years. The first patient was enrolled into the ABSORB BTK trial by Marc Bosiers, M.D., head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium.

"Patients with critical limb ischemia often progress to where they have few options beyond limb amputation, so there is a tremendous need for new therapies to prevent this outcome," said Dierk Scheinert, M.D., Professor of Medicine, the University of Leipzig, Germany, and principal investigator of the ABSORB BTK trial. "The ABSORB device represents the next generation in revascularization therapies that may hold promise for patients with vessel disease in the lower leg. With the ABSORB BTK trial, we will test whether this novel approach - restoring blood flow with a temporary scaffold - has the potential to improve the outcomes of patients with critical limb ischemia."

The ABSORB device is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Because a permanent metallic implant is not left behind, naturally occurring vessel functions may be restored, which is one of the features that make this device a significant innovation. In January 2011, Abbott announced that ABSORB received CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. ABSORB currently is under development and is not available for sale in the United States.

ABSORB BTK is a prospective, single-arm, multi-center trial designed to evaluate the safety and efficacy of the ABSORB device in up to 90 patients with below-the-knee critical limb ischemia at up to 10 clinical trial sites in Europe and New Zealand. The primary endpoint is a composite of freedom from major adverse limb events (major amputation or major re-interventions) within one year or death within 30 days of the procedure.

"With the ABSORB BTK trial, we will be able to evaluate our bioresorbable drug and device technology as a potentially new therapeutic option for patients with below-the-knee critical limb ischemia," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "Our efforts to apply this technology to the treatment of vascular diseases beyond coronary artery disease underscore our continued commitment to developing innovative products to improve vascular care for patients."

About Critical Limb Ischemia

Critical limb ischemia is a severe form of peripheral artery disease (PAD) that is characterized by chronic pain, even at rest, as well as ulcers and gangrene (tissue death) that develop as a result of chronically poor blood flow to the lower limbs. Endovascular treatments of below-the-knee arteries, including balloon angioplasty and stenting, have emerged as effective forms of therapy. For some patients, surgical bypass procedures are performed. If left untreated, the disease can eventually lead to amputation and limb loss.

In January 2011, Abbott announced that the XIENCE PRIME™ Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of critical limb ischemia or severe claudication (pain) of the lower leg. In the U.S., XIENCE PRIME currently is an investigational device and not available for sale. Additional information about XIENCE PRIME is available online at http://www.abbottvascular.com.

About the ABSORB Clinical Trials for Coronary Artery Disease

Abbott has conducted one clinical trial called ABSORB and currently is conducting a second trial called ABSORB EXTEND to evaluate the company's bioresorbable device for the treatment of coronary artery disease. The ABSORB trial is a prospective, non-randomized, two-stage study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety - major adverse cardiac events (MACE) and treated-site thrombosis rates - as well as an assessment of the acute performance of the device.

Results from the first stage of the ABSORB trial showed that in 30 patients, no blood clots (thromboses), no cardiac deaths out to four years and no new MACE between six months and four years were reported. Twelve-month results from the second stage showed that in 101 patients, the MACE rate was 6.9 percent and no blood clots were reported.

The ABSORB EXTEND trial is a large-scale, single-arm study that will evaluate ABSORB in patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients with complex coronary artery disease.

ABSORB delivers everolimus, an anti-proliferative drug. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated-site neointimal growth in the coronary vessels following vascular device implantations, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.  

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.

Modal title

Also from this source

New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib

New Clinical Study Data Showcase Long-Term, Sustained Benefits of Abbott's Volt™ PFA System for Patients with AFib

Abbott (NYSE: ABT) has announced new data from its Volt CE Mark Study that show strong safety and efficacy out to 12 months for patients receiving...

Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms

Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms

Abbott (NYSE: ABT) today announced it has received CE Mark in Europe for the Volt™ PFA System to treat patients battling atrial fibrillation (AFib)....

More Releases From This Source

Explore

Biotechnology

Biotechnology

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Medical Equipment

Medical Equipment

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.