- A Research Letter in Circulation details feasibility results from the first 10 patients treated in a clinical trial to soften calcified aortic heart valves.
- Six participants responded to the treatment, possibly due to a longer duration of therapy.
- Cardiawave is developing Valvosoft®, an investigational device, not approved for marketing and not CE-marked, to mechanically soften the hardened valves, improve valve function, and reduce symptoms.
Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients with Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study
A team of clinicians and researchers from France and the Netherlands published a Research Letter in Circulation to share feasibility results from the first 10 patients treated in a clinical trial using focused ultrasound to soften calcified aortic heart valves.
This problem, called calcific aortic stenosis, is the most common disease for heart valves, but 16% of patients with this condition cannot receive surgical or transcatheter aortic valve replacement due to age, comorbidities, or access issues.
The study uses Cardiawave’s Valvosoft®, an investigational device, which is being developed to mechanically soften the hardened valves, improve valve function, and reduce symptoms.
Pulsed mechanical energy is applied using a transthoracic transducer under ultrasound guidance for users. Six of the ten participants were considered to be responders to the treatment, possibly due to a longer duration of the therapy. The primary safety endpoint of the study was met with no adverse event within 30 days following the therapy. In all, the trial aims to enroll 30 participants.