Valvosoft's Non-Invasive Ultrasound Therapy in patients with severe aortic stenosis improved KCCQ scores by 8.6 points at 12 months, with a 30-day procedure-related mortality of 2%.
Observational (n=100)
Yes
Does Valvosoft's Non-Invasive Ultrasound Therapy improve quality of life and valve hemodynamics in patients with severe symptomatic aortic stenosis?
Non-Invasive Ultrasound Therapy (NIUT) for severe symptomatic aortic stenosis demonstrates feasibility, safety, and meaningful improvements in quality of life and valve hemodynamics at 12 months.
Abstract Aim Aortic stenosis (AS) is the most common heart valve disease causing frailty-linked symptoms, reduced quality-of-life, and severe risks like heart failure or sudden death. Non-Invasive Ultrasound Therapy (NIUT) for calcific AS provides a safe and effective valve repair opportunity, being an alternative care for patients not recommended for immediate AVR. Many patients remain untreated due to the risks of invasive procedures, comorbidities, or a preference against surgery. Methods We present the QoL outcomes of 100 patients treated with Valvosoft’s NIUT, with follow-up data up to 12 months. The therapy involves the transthoracic delivery of precise, short, high-intensity focused ultrasound pulses to nucleate a cavitation bubble cloud over the aortic valve. This process effectively fractures calcifications and softens valve leaflet tissue. Real-time echocardiographic ultrasound imaging allows precise operator procedure guidance and monitoring. Between 2019 and 2024, three prospective, multi-center, single-arm studies were conducted to evaluate the feasibility, safety, and performance of Valvosoft for treating patients with severe AS: two First-In-Human studies involving 40 patients and a pivotal study with 60 patients, for a total of 100 severe symptomatic AS patients. Patients, advanced in age (84.3 ± 8.8) with multiple comorbidities and compromised QoL, were enrolled in 12 centers in Europe. NIUT was delivered for up to 60 minutes in FIM studies and extended to 70 minutes in Pivotal study, per procedure, and patients were awake or lightly sedated. Overall QoL showed improvement, the KCCQ increased 8.6 points in score (16.8%) from 51.2±21.5 at baseline to 59.8±21 at 12 months. Consistently, 85% of patients experienced stabilization or improvement in their NYHA functional class. Performance at 12 months was demonstrated by a 17% increase in AVA from 0.62±0.19 cm² at baseline to 0.75±0.25 cm², or 44.2% compared to the natural history of the disease1. As primary safety endpoints, procedure-related mortality at 30 days was 2%, with both deaths adjudicated by the Clinical Events Committee (CEC) as possibly related to the procedure. The MACE rate at 30 days was 9%: 6 deaths (2 possible related to procedure, 1 possible related to device), 1 MI, 1 heart failure, 1 major bleeding. The event code was confirmed by CEC. Conclusion Valvosoft's Non-Invasive Ultrasound Therapy successfully treated 100 patients with AS, achieving a consistent quality-of-life improvement for patients. A strong safety profile and consistent performance outcomes were also reached. The therapy demonstrated low procedure-related mortality and an acceptable rate of adverse events, alongside meaningful improvements in aortic valve function and hemodynamics. These results highlight the potential of Valvosoft's innovative approach to address an unmet need in the treatment of severe AS.
Messas et al. (Sat,) conducted a observational in Severe symptomatic aortic stenosis (n=100). Valvosoft Non-Invasive Ultrasound Therapy (NIUT) was evaluated on Procedure-related mortality at 30 days. Valvosoft's Non-Invasive Ultrasound Therapy in patients with severe aortic stenosis improved KCCQ scores by 8.6 points at 12 months, with a 30-day procedure-related mortality of 2%.