Cardiawave’s innovative Valvosoft® device introduces a groundbreaking, non-invasive ultrasound therapy (NIUT) for treating severe symptomatic aortic stenosis (sSAS)—a condition that predominantly affects elderly patients and often lacks safe, viable treatment options. Unlike traditional surgical or catheter-based interventions, Valvosoft® uses externally applied therapeutic ultrasound to improve heart valve function without the need for incisions or anesthesia. The 12-month results from the Valvosoft® First-in-Human and Pivotal Studies, presented at the EuroPCR Congress, demonstrated not only the feasibility of the therapy but also a favorable safety profile, with 91% of patients free from major adverse cardiac events within the first 30 days.

The therapy was tested across 100 elderly patients with multiple comorbidities in 12 European centers, reinforcing its value as a real-world solution for a vulnerable population often excluded from surgical interventions. At the one-year mark, patients experienced significant improvements in cardiac function and quality of life, confirming the long-term efficacy of the device. These results suggest that Valvosoft® could be deployed not just as a primary therapy for inoperable sSAS patients but also as a preparatory option for those undergoing transcatheter aortic valve implantation (TAVI), broadening its clinical utility.

As aging populations drive up the prevalence of sSAS—estimated to affect 2.5 million individuals over 75 in the U.S. and EU—Valvosoft® stands out as a transformative solution. With regulatory pathways advancing in both Europe and the U.S., Cardiawave is positioning the device for commercial launch in the near future. The success of these studies not only confirms Valvosoft®'s therapeutic potential but also signals a paradigm shift in managing valvular heart disease with safe, accessible, and non-invasive alternatives.

MedTech Spectrum's Summary

Innovative Non-Invasive Treatment : Cardiawave's Valvosoft® device offers the first non-invasive ultrasound therapy for severe symptomatic aortic stenosis (sSAS), improving cardiac function without surgery or catheter-based intervention.

Strong Clinical Outcomes : In a study of 100 elderly patients, 91% were free from major adverse cardiac events at 30 days, and one-year follow-up showed sustained improvements in heart function and quality of life.

Path to Global Impact : With regulatory steps underway, Valvosoft® is on track for European market launch, potentially transforming care for millions of aging patients worldwide who currently lack safe treatment options.