OUR DEVICE: VALVOSOFT ®

A NON-INVASIVE ULTRASOUND THERAPY DEVICE FOR THE TREATMENT OF CALCIFIC AORTIC STENOSIS

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.

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.

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.

AN UNDERLYING DISRUPTIVE TECHNOLOGY

The disruptive and patented technology developed by Cardiawave is unique and will offer several advantages over state-of-the-art. It will allow physicians to deliver with a NIUT medical device mechanical energy on a moving target with precision, while at the same time preserving the tissue and organs through which the ultrasound passes.

Unlike any existing technology, it is possible to target and treat several anatomical zones spread over a large area without physically moving the medical device, which is placed on the patient’s chest, over the beating heart. Treatment is monitored by the user via real-time ultrasound imaging.

VALVOSOFT®: NON-INVASIVE ULTRASOUND THERAPY (NIUT)

1280-Tableau-Therapeutic-Ultrasounds-fd-tr
  • 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

Non-eligible

ALTERNATIVE ANSWER TO NON-ELIGIBLE PATIENTS

Patients severely affected and not recommended to current medical response or refusing them can benefit from our treatment.

Non-invasive

NON-INVASIVE TREATMENT

Our treatment is completely non-invasive. No surgery is required. The procedure can be done ambulatory.

Life-quality

PATIENT QUALITY OF LIFE IMPROVED

Our solution improves the quality of life of patients.

Decrease

LOWER RISKS AND COMPLICATIONS

Valvosoft® device may decrease mortality, risks and complications.

Immediate-effect

REPEATED TREATMENT

Our treatment can be repeated.

Patients

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.

More information

For more information and to access our detailed documentation regarding Valvosoft®, please contact Cardiawave at contact@cardiawave.com.
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