FIH Study of AngioScore's CardioSculpt Valvuloplasty Scoring Balloon Begins Enrollment

October 17, 2012—AngioScore, Inc. (Fremont, CA) announced the successful initiation of enrollment in the CardioSculpt Valvuloplasty Scoring Balloon for Critical Aortic Valve Stenosis First-in-Human (FIH) Study, which will enroll 30 patients with symptomatic critical aortic valve stenosis at St. Paul's Hospital at the University of British Columbia in Vancouver, Canada, under the directions of Principal Investigator Prof. John G. Webb, MD.

The CardioSculpt FIH study is a 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 transcatheter or surgical valve replacement or as a bridge to these procedures. The investigators will assess the aortic valve area and hemodynamics pre- and postintervention during the index cardiac catheterization procedure. Patients will be followed clinically and with serial transthoracic echocardiography at 30 days, 6 months, and 12 months.

In its press release, the company stated that AngioSculpt scoring balloon catheters are designed for angioplasty procedures to treat both coronary and peripheral artery disease. The catheters' nitinol elements provide circumferential scoring of plaque and are designed to lead to precise and predictable luminal enlargement across a wide range of lesion types; antislippage properties are intended to prevent “geographic miss.”

AngioScore noted that 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 fibrocalcific narrowing of degenerated aortic valves. The CardioSculpt is currently investigational and is not available for sale in the United States, Canada, or Europe.