A MEDICAL DEVICE FOR NON-INVASIVE ULTRASOUND TREATMENT OF AORTIC STENOSIS

To treat Aortic Stenosis, Cardiawave has developed a non-invasive, real-time image-guided medical device using a cutting-edge ultrasound technology.

Non-Invasive Ultrasound Therapy (NIUT) consists in repairing the aortic valve, not replacing it. No surgery is required. Our unique approach could represent both an alternative and a complementary approach to current procedures.

Valvosoft® is a medical device exclusively for clinical investigations. 

Valvosoft®, our investigational device, delivers focused high-intensity ultrasounds with precision to perform a remote and reparative effect on the aortic valve leaflets. The energy is mechanical (bubbles cavitation and shockwaves), non-thermal. Aortic valve leaflets tissues are softened, restoring their mobility and improving the anatomical (Aortic Valve Area) and hemodynamical (Pressure Gradient) parameters following the procedure.

AN UNDERLYING DISRUPTIVE TECHNOLOGY

The disruptive and patented technology developed by Cardiawave is unique and offers several advantages over state-of-the-art. It allows physicians to deliver with a non-invasive 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 via ultrasound imaging in real time.

VALVOSOFT®: NON-INVASIVE ULTRASOUND THERAPY (NIUT)

  • Focused, very high frequency and short ultrasound pulses create microscopic cavitation bubbles
  • When cavitation bubbles burst, they produce shockwaves
  • Shockwaves cause microfragmentation in valve calcium

EXPECTED BENEFITS AND ADVANTAGES

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ALL PATIENTS TREATED AT AN EARLIER STAGE

Our investigational device should slow down the progression of the disease and be used as preventive medicine for all patients.

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NON-INVASIVE TREATMENT

The treatment is completely non-invasive. No surgery is required. We expect the procedure to rapidly become ambulatory.

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DECREASE OF MORBIDITY RATES

Our CE-unmarked device should decrease morbidity rates, risks and complications.

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ANSWER TO NON-ELIGIBLE PATIENTS

Patients severely affected and not eligible to current medical response should benefit from our treatment.

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LIFE QUALITY OF THE PATIENTS IMPROVED

Our solution should improve the quality of life of patients.

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IMMEDIATE EFFECT

The treatment should have an immediate effect and possibly may be repeated.