Our device: Valvosoft®
A non-invasive ultrasound therapy device for the treatment of calcific aortic stenosis.
Soften the aortic valve without replacing it through a surgical procedure
To treat calcific Aortic Stenosis (AS), Cardiawave has developed 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 for SAVR/TAVR (Surgical/Transcatheter Aortic Valve Replacement) or refusing such intervention, and a complementary approach to current procedures to prepare overly calcified aortic valves before the deployment of a TAVR.
EU & US Regulatory Status Notice
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.
An underlying disruptive technology
The disruptive and patented technology developed by CardiaWave uses a HIFU medical device to generate mechanical energy on a moving target with precision while preserving tissue and organs.
Unlike existing technology, it targets and treats abnormal aortic valve tissue over a large area without physically touching the medical device to the patient. This remote capability mitigates traditional contact risks and introduces unprecedented flexibility to cardiac workflows.
Valvosoft®, delivers focused high-intensity ultrasound with precision to perform a remote and reparative effect on the aortic valve leaflets. The energy is mechanical (cavitation bubbles inducing shockwaves), non-thermal. Aortic valve leaflets tissues are softened, restoring their mobility and improving the anatomical and hemodynamical parameters following the procedure.
A pioneer’s perspective
In this 2023 interview, Professor Alain Cribier — pioneer of transcatheter aortic valve implantation (TAVI) and a former member of Cardiawave’s Scientific Advisory Board — shares his perspective on Valvosoft and its potential in the treatment of aortic stenosis.
His insights highlight the importance of developing truly non-invasive solutions to address unmet clinical needs and improve patient care. His vision continues to inspire innovation in structural heart therapies.
Valvosoft®: Non-invasive ultrasound therapy (NIUT)
| Therapeutic Ultrasound | NIUT | Lithotripsy | HIFU* |
|---|---|---|---|
| Ability to penetrate deep in tissue | |||
| Propagation of tissue through which ultrasounds pass | |||
| Energy | Mechanical | Mechanical | Mechanical |
| Therapeutic effect | Tissue softening | Break-up of stone | Tissue ablation |
* HIFU = High-Intensity Focused Ultrasound
- Focused, very high frequency and short ultrasound pulses create microscopic cavitation bubbles
- When cavitation bubbles burst, they produce shockwaves
- Shockwaves cause microcracks in valve calcium
Expected benefits and advantages
Alternative to non-eligible patients
Patients clinically difficult and not recommended to current medical approaches can hope their case benefits from our treatment.
Non-invasive treatment
Our treatment is completely non-invasive; no surgery is required. The procedure can be done ambulatory.
Patient quality of life improved
Our solution improves the quality of life of patients.
Lower risks and complications
ValvoSoft® does bring decreased risks, infections, and complications.
Repeated treatment
Our treatment can be repeated.
Patients potentially treated at an earlier stage
In the future Valvosoft ® should be used as a tool to slow down the progression of the disease and be used as preventive treatment for young patients or at an earlier stage of the disease.
For more detailed information
For more information and to access our detailed documentation regarding Valvosoft®, please contact Cardiawave.
