Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

AngioScore Announces Successful Initiation of Enrollment in Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human Study

December 15, 2011 By AxoGen, Inc.

FREMONT,
Calif.–(BUSINESS WIRE)–AngioScore, Inc., a
developer of novel angioplasty catheters for use in the treatment of
cardiovascular disease, today announced the successful initiation of enrollment
in the Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human (FIH)
Study.

This FIH trial of a novel drug-coated scoring balloon will
enroll 60 patients with coronary in-stent restenosis (ISR) at three renowned
international sites, two in Germany
and one in Brazil.
The study will be led by Bruno Scheller, M.D., Professor of Interventional
Cardiology at Saarland University Hospital, Homburg, Germany, who along with
Professor Ulrich Speck of the Charite Hospital in Berlin, is one of the
preeminent pioneers in the rapidly developing field of drug-coated balloons for
the treatment of coronary and peripheral artery disease. “The development of a
Drug-Coated AngioSculpt could represent a major advance in the percutaneous
treatment of endovascular disease,” said Professor Scheller. “I am honored to
lead this important study and to collaborate with such an internationally
prominent interventional cardiologist as Professor Alexandre Abizaid and his
team at Dante Pazzanese Institute of Cardiology in Sao Paulo, Brazil.”

“The AngioSculpt Scoring Balloon Catheter represents a
significant improvement over conventional angioplasty balloon catheters for the
treatment of challenging coronary and peripheral lesions because of its ability
to achieve more predictable luminal expansion, avoid slippage or geographic
miss and result in a lower rate of dissection. These features may be
particularly valuable in the field of drug-coated balloons by ensuring more
precise delivery of the anti-proliferative drug and potentially obviating the
need to deploy a stent in a significant proportion of lesions,” said Gary
Gershony, M.D., Co-Founder and Chief Medical Officer of AngioScore. “Extensive
pre-clinical studies performed by Professors Speck and Scheller have demonstrated
the safety of a drug-coated AngioSculpt and its ability to have a profound
effect on preventing restenosis. These studies have laid the groundwork for
proceeding with a FIH clinical trial.”

The drug-coated AngioSculpt FIH study is designed as a
randomized controlled trial and will compare the recently developed drug-coated
AngioSculpt with the commercially available uncoated version in patients
presenting with significant restenosis in a previously implanted coronary bare
metal stent. Patients will undergo follow-up coronary angiography at six months
to compare the rate of recurrent restenosis and late lumen loss (LLL) in both
treatment arms. Additional study endpoints include the rate of major adverse
cardiovascular events (MACE), clinically driven target lesion revascularization
(TLR) and stent thrombosis for up to two years following the index procedure.
All angiograms will be analyzed by an independent core laboratory at the
Cardiovascular Research Foundation in New
York, N.Y.

Over three million coronary and peripheral angioplasty
procedures are performed annually worldwide. A majority of these lesions are
treated with permanent stents that often require concomitant treatment with a
prolonged course of dual anti-platelet therapy to avoid the potentially
life-threatening complication of stent thrombosis, adding significantly to the
procedural costs and to the long-term risk of serious bleeding complications.
Additionally, there are important lesion subsets which may not be suitable for
stenting including diffusely diseased and smaller-caliber vessels, restenosed
stents and certain peripheral vessels. A drug-coated AngioSculpt may allow a
shortened course of dual anti-platelet therapy and has the potential to
transform the treatment of many patients presenting with these challenging
lesions.

The AngioSculpt Scoring Balloon Catheters represent the next
generation in angioplasty catheters for both coronary and peripheral artery
disease. Their innovative nitinol elements provide unique circumferential
scoring of plaque, leading to precise and predictable luminal enlargement
across a wide range of lesion types while avoiding “geographic miss” through
their unique anti-slippage properties. The AngioSculpt catheters provide the
versatility and effectiveness of a new technology together with the simplicity
and deliverability of traditional high-performance balloon catheters.

AngioSculpt catheters have now been used in more than
100,000 procedures worldwide and have achieved an outstanding safety and performance
record in the treatment of both coronary and peripheral artery disease.

The drug-coated AngioSculpt is currently investigational and
not available for sale in the U.S.
or Europe.

About AngioScore

AngioScore, Inc (www.angioscore.com) is a privately funded endovascular
company located in Fremont,
California. AngioScore can be
contacted at (510) 933-7900 or info@angioscore.com

Posted by Sean Fenske, Editor-in-Chief, MDT

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech