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
