French medtech company Cardiawave has disclosed promising 12-month results from its Valvosoft FIM and Valvosoft Pivotal studies at the EuroPCR Congress, highlighting the potential of its non-invasive ultrasound therapy (NIUT) device for the treatment of severe symptomatic aortic stenosis (sSAS).
This technology targets a growing population of patients over 75 years old in the European Union (EU) and the US.
The trials included two first-in-human studies and a multicenter, prospective, single-arm pivotal study, involving 100 elderly patients with multiple comorbidities across 12 European centres in four countries.
Consistent with earlier clinical studies, the recent findings confirm the promise of NIUT. At 30 days, 91% of patients were free from major adverse cardiac events (MACE), successfully meeting the primary endpoint objective of MACE ≤ 25%.
Additionally, 85% of participants showed improvement or stabilisation in their NYHA class.
Moreover, there was an average 9-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, indicating a notable enhancement in quality of life.
At the 12-month mark, a significant 43% increase in aortic valve area (AVA) was observed compared to the natural progression of sSAS, demonstrating the treatment’s efficacy.
Cardiawave’s leadership team said: “These results are very encouraging. They reinforce our determination to make this non-invasive therapy accessible to as many people as possible, including for complementary indications such as pre-TAVI preparation.
“We are excited to move forward with regulatory steps in Europe and the US, aiming for a European market launch next year.”
Valvosoft offers a potential non-invasive therapeutic alternative for sSAS, a degenerative condition with limited existing treatment options.
While still investigational, the device applies focused high-intensity ultrasounds to deliver mechanical energy to the aortic valve leaflets, facilitating tissue mobility and improving anatomical and hemodynamic parameters.
The patented technology allows precise targeting without moving the device from its position on the patient’s chest over the heart. The procedure is monitored via real-time ultrasound imaging to ensure accurate delivery and preservation of adjacent tissues.
