Healthcare Industry News: drug-eluting stent
News Release - June 4, 2008
AngioScore Announces Initiation of Enrollment in Multi-Center Coronary Artery Bifurcation TrialFREMONT, Calif.--(HSMN NewsFeed)--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 AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study, or AGILITY trial.
The AGILITY trial will enroll 100 patients with coronary bifurcation lesions at eight premier interventional cardiology programs in the U.S. and follow these patients for nine months. Jeffrey Moses, M.D., Professor of Medicine and Director of the Cardiac Catheterization Laboratories at Columbia University Medical Center, will serve as the overall trial Principal Investigator. “The AngioSculpt® Scoring Balloon represents a significant advance in the treatment of complex coronary lesions, including bifurcations. I am delighted to lead this important study and am honored that such a prominent group of interventional cardiologists will also be participating.”
“The AngioSculpt® represents a significant improvement over conventional angioplasty balloon catheters for the treatment of challenging lesions because of its ability to achieve more predictable luminal expansion and a lower rate of dissection. This may be particularly valuable in bifurcation side-branch lesions – potentially minimizing the need to place a second stent in the branch vessel,” said Gary Gershony, M.D., Co-Founder and Chief Medical Officer of AngioScore.
In January 2007, the AngioSculpt® Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter received FDA Pre-market Application (PMA) Approval for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
Coronary artery bifurcation lesions represent 25%-30% of the more than one million percutaneous interventions performed annually in the United States. Bifurcation lesions are challenging to treat because of the lack of commercially available coronary stents that are suitable for the heterogeneous morphologies associated with these lesions. In addition, conventional balloon angioplasty catheters often prove inadequate for treating the side-branch vessel due to frequent plaque shift and a high rate of dissection. Recent studies have also shown that placing a second stent in the side-branch vessel is associated with a higher rate of acute and long term complications.
The AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study (AGILITY) (ClinicalTrials.gov Identifier: NCT 00686647) is a prospective, multi-center, single arm study evaluating the AngioSculpt® as the primary treatment of the side-branch vessel along with an approved drug-eluting stent for the main branch vessel. Patients will be followed at one month for safety outcomes and at nine months for clinical evidence of restenosis (TLR).
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 15,000 procedures worldwide and have achieved an outstanding performance record in the treatment of both coronary and peripheral artery disease.
AngioScore, Inc. (www.angioscore.com) is a privately funded endovascular company located in Fremont, California. AngioScore can be contacted at (510) 933-7900 or firstname.lastname@example.org.
Note: This press release contains forward-looking statements that are based upon management’s current expectations and are inherently uncertain. Actual results and timing of events could differ materially from current expectations and forward-looking statements.
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