Novel Treatment for Severe Aortic Stenosis on Track for FDA Nod

Results from Cardiawave’s Valvosoft pivotal study of 60 patients with severe symptomatic calcific aortic stenosis suggest treatment with the investigational noninvasive ultrasound therapy device achieved its primary endpoint, with nearly 92% of patients remaining free of major adverse cardiac events (MACE) at 30 days. Six-month data show use of the technology may also reverse or slow disease progression and improve quality-of-life.