FREMONT, Calif.--()--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 “CardioSculpt” Valvuloplasty Scoring Balloon for Critical Aortic Valve Stenosis First-in-Human (FIH) Study.
“This may lead to a more durable standalone result or bridge to trans-catheter or surgical valve replacement.”
This FIH trial of a novel Valvuloplasty Scoring Balloon will enroll 30 patients with symptomatic critical aortic valve stenosis at the renowned trans-catheter aortic valve replacement (TAVR) program at St. Paul’s Hospital, University of British Columbia in Vancouver, Canada, headed by Professor John Webb.
“The CardioSculpt Valvuloplasty Scoring Balloon may represent a significant improvement over conventional valvuloplasty balloon catheters for the treatment of critical aortic valve stenosis by achieving a more predictable and optimal enlargement of the aortic valve area,” said Gary Gershony, M.D., Co-Founder and Chief Medical Officer of AngioScore. “This may lead to a more durable standalone result or bridge to trans-catheter or surgical valve replacement.”
The CardioSculpt FIH study is a 30-patient prospective single-arm study evaluating the Valvuloplasty Scoring Balloon in patients with symptomatic critical aortic valve stenosis who are not deemed to be candidates for trans-catheter or surgical valve replacement or as a bridge to these procedures. Careful assessment of the aortic valve area and hemodynamics pre- and post-intervention will be performed during the index cardiac catheterization procedure. Patients will be followed clinically and with serial trans-thoracic echocardiography at 30 days, 6 months and 12 months.
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 and are designed to lead 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 are designed to provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters. The development of the CardioSculpt Valvuloplasty Scoring Balloon for the treatment of critical aortic valve stenosis aims to extend the known mechanical benefits of this technology platform to the fibro-calcific narrowing of degenerated aortic valves, which is the most common serious valvular heart disease in the developed world.
AngioSculpt catheters have now been used in more than 200,000 endovascular procedures worldwide and have achieved an outstanding safety and performance record in the treatment of both coronary and peripheral artery disease.
The CardioSculpt Valvuloplasty Scoring Balloon is currently investigational and not available for sale in the U.S., Canada or Europe.
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.