AngioScore has begun patient enrollment in a first-in-human (FIH) study of its CardioSculpt Valvuloplasty Scoring Balloon catheter, designed to treat patients with symptomatic critical aortic valve stenosis.
CardioSculpt catheter, which includes nitinol elements, provides unique circumferential scoring of fibro-calcific plaques to enlarge the luminal space of aortic valve area.
The prospective, single-arm study, which will enroll 30 patients, is designed to demonstrate the safety and efficacy of CardioSculpt catheter in critical aortic valve stenosis patients who are not deemed to be candidates for trans-catheter or surgical valve replacement or as a bridge to these procedures.
During the index cardiac catheterization procedure, aortic valve area and hemodynamics pre- and post-intervention will be assessed.
The company said trans-thoracic echocardiography will be performed serially in patients implanted with CardioSculpt catheter at 30 days, 6 months and 12 months.
AngioScore co-founder and chief medical officer Gary Gershony said the CardioSculpt Balloon represents 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.
"This may lead to a more durable standalone result or bridge to trans-catheter or surgical valve replacement," Gershony added.
The company said the investigational CardioSculpt catheter is not available for sale in the US, Canada or Europe.