June 5, 2008 – AngioScore started enrollment in the AngioSculpt Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study (AGILITY), designed to compare AngioSculpt Scoring Balloon Catheters in treating bifurcation lesions over conventional angioplasty balloon catheters.
The AngioSculpt Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study (AGILITY) is a prospective, multicenter, 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 use nitinol elements for circumferential scoring of plaque, designed to lead to 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 raditional high-performance balloon catheters.
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 is engineered to improve upon 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.
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.
For more information: www.angioscore.com