Current medical response
The only medical response to severe symptomatic Aortic Stenosis (sSAS) is currently a valve replacement, either by open-heart surgery (surgical aortic valve replacement or SAVR) or by a less-invasive procedure called TAVR (Transcatheter Aortic Valve Replacement). Unfortunately, not all sSAS patients are eligible for SAVR or TAVR (16%) (1) and some refuse such intervention.
1 Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI: 10.1093/eurheartj/ehy107)
Open heart surgery (SAVR)
The standard treatment consists in replacing the aortic valve with a biological or mechanical prosthesis during open-heart surgery, performed under cardiopulmonary bypass, which temporarily takes over the function of the heart and lungs while the heart is deliberately stopped to allow for a safe and precise valve replacement (1).
1 The Evolution of Heart Surgery. Electrophysiology and Heart Rhythm Disturbances Team. Lifespan. June 13, 2018.
Transcatheter aortic valve replacement (TAVR)
Since 2007, a new technique for minimally invasive endovascular intervention called TAVR has been used with good results. This procedure involves replacing the aortic valve via a percutaneous approach, most commonly through the femoral artery (transfemoral route), which provides access to the aortic valve via the arterial system. Other approaches: Transapical (left ventricular apex), Transaortic (via upper mini-sternotomy or right anterior thoracotomy), Transaxillary or subclavian artery, Transcarotid.
1 The Evolution of Heart Surgery. Electrophysiology and Heart Rhythm Disturbances Team. Lifespan. June 13, 2018.
Our Solution: a non-invasive ultrasound therapy
To treat calcific AS, Cardiawave has developed Valvosoft®, a Non-Invasive Ultrasound Therapy (NIUT). NIUT consists in softening the aortic valve, not replacing it. No surgery is required. Our unique approach could represent both an alternative for patients not recommended or refusing such intervention for SAVR/TAVR (Surgical/Transcatheter Aortic Valve Replacement) and a complementary approach to current procedures to prepare overly calcified aortic valves before the deployment of a TAVR.
Valvosoft® is CE-marked in the European Union when intended for the treatment of patients with severe symptomatic calcific Aortic Stenosis (AS) by non-invasive ultrasound therapy (NIUT). In the United States of America, Valvosoft® is not yet approved by the FDA and is not commercially available.
1 The Evolution of Heart Surgery. Electrophysiology and Heart Rhythm Disturbances Team. Lifespan. June 13, 2018.
Current standard of care
- Patients with no medical response
- Invasive treatment
- Length of stay in hospital
- Valve replacement
- Risks and Complications, re-hospitalization
- Overall actual cost: from €50 to €80k (1) (2)
Now thanks to Cardiawave
- New eligible patients with currently no medical option – Preventive treatment
- Non-Invasive treatment
- Ambulatory treatment, short patient length of stay in hospital
- Softening of native valve
- Quality of Life improvement, shorter patient recovery time
- Decrease of cost per procedure
1 Reynolds MR, et al. Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). American Heart Journal, Circulation. February 03, 2012. (DOI: 10.1161/CIRCULATIONAHA.111.054072)
2 Chevreul K, et al. Cost of transcatheter aortic valve implantation and factors associated with higher hospital stay cost in patients of the FRANCE (French Aortic National CoreValve and Edwards) registry. Cardiovascular Disease. April 24, 2013. (DOI: 10.1016/j.acvd.2013.01.006)
Patient recovery & real-world outcomes
Margarethe, 79 (Munich, Germany)
Severe Calcified Stenosis
14 novembre 2025
“As an inoperable patient, I felt like I was out of options. Being part of the clinical study for this French ultrasound device was a true miracle. The treatment was fast, painless, and I went home the same day.”
Jean-Pierre, 82 (Paris, France)
Symptomatic Aortic Stenosis
14 novembre 2025
“The prospect of open-heart surgery terrified me at 82. Valvosoft gave me my life back without an implant. Within a month, I was walking my dog in the garden again, completely pain-free.”