Endovascular company AngioScore has commenced patient enrolment of a first-in-human (FIH) study to evaluate its CardioSculpt Valvuloplasty Scoring Balloon catheter in patients with symptomatic critical aortic valve stenosis.
The catheter features nitinol elements which provide unique circumferential scoring of fibro-calcific plaques to enlarge the luminal space of aortic valve.
The prospective single-arm study will enrol 30 patients to demonstrate the safety and efficacy of CardioSculptin 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.
Aortic valve area and hemodynamics pre and post-intervention will be assessed during the index cardiac catheterisation procedure.
Patients implanted with CardioSculpt will undergo trans-thoracic echocardiography serially at 30 days, 6 months and 12 months, according to the company.
AngioScore co-founder and chief medical officer Dr Gary Gershony said the CardioSculpt Balloon represents a significant improvement over conventional valvuloplasty balloon catheters 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 said.
The CardioSculpt catheter, which is currently investigational, is not available for sale in the US, Canada or Europe.