Angioplasty catheter manufacturer AngioScore successfully initiated a 1st-in-human trial evaluating its CardioSculpt valvuloplasty scoring balloon in treatment of critical aortic valve stenosis.
The study will enroll 30 patients with symptomatic critical aortic valve stenosis who are not eligible for transcatheter treatment or surgical valve replacement.
The patients are from the transcatheter aortic valve replacement program at St. Paul’s Hospital at the University of British Columbia in Vancouver, Canada, and they will be followed clinically and with serial transthoracic echocardiography at 30 days, 6 months and 12 months, according to the press release.
“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,” Dr. Gary Gershony, co-founder & CMO, said in prepared remarks. “This may lead to a more durable standalone result or bridge to trans-catheter or surgical valve replacement.”
AngioScore’s AngioSculpt Scoring Balloon Catheter in 2004 received CE Mark approval in the European Union for treatment in the coronary arteries and in 2005 landed an FDA nod for balloon dilatation of lesions in infrapopliteal arteries, according to the company’s website.
The CardioSculpt Valvuloplasty Scoring Balloon is on the market in the U.S., Canada or Europe.