Cardiawave has announced the first routine clinical treatments using its Valvosoft® system following CE Mark approval, marking the start of the technology’s commercial deployment across Europe.
The non-invasive ultrasound therapy is designed to treat patients with severe symptomatic aortic stenosis who are not suitable for immediate valve replacement or choose not to undergo surgery.
Aortic stenosis is a progressive condition caused by the build-up of calcium on the aortic valve, restricting blood flow from the heart to the rest of the body.
If left untreated, it can lead to chest pain, heart failure and an increased risk of sudden cardiac death. Conventional treatment generally involves surgical or transcatheter valve replacement.
Valvosoft® offers a different treatment approach by restoring the movement of the patient's natural valve without surgery or implanting an artificial valve. The system uses high-intensity ultrasound pulses to break down calcium deposits on the valve leaflets while preserving surrounding tissue.
This non-invasive procedure is designed to improve valve function and blood flow without the need for general anaesthesia.
Clinical evidence from two European studies involving 100 patients demonstrated the safety and effectiveness of the technology, with improvements reported in cardiac function and patient quality of life after treatment.
Following CE Mark approval, Valvosoft® systems have entered routine clinical use in several hospitals across France, Germany and the Netherlands.
Cardiawave is now expanding the technology across Europe while preparing regulatory activities for the United States.
The company is also strengthening manufacturing capacity and advancing further clinical studies to support wider adoption of non-invasive treatment options for aortic stenosis.
