USA — Cardiawave, a medical device manufacturer has secured three U.S. patents for its Valvosoft ultrasound device for treatment of aortic stenosis.
The issuance of three new patents in the United States, which protect Cardiawave’s ultrasound imaging and therapy device and its medical applications, is a significant development.
It strengthens the company’s U.S. patent portfolio for its innovative non-invasive treatment of heart valve diseases and other cardiovascular applications, and paves the way for Cardiawave to bring its medical device to the American market.
The company is currently conducting a clinical study in Europe to obtain the CE Mark there for Valvosoft; ultimately, it plans to bring the device to the American market, it said.
The first U.S. Patent protects Cardiawave’s ultrasound imaging and therapy device, specifically the system that allows for optimal imaging for safety and performance purposes.
The second U.S. Patent protects the technology and means to detect and monitor, with ultrasound imaging, the cavitation bubbles which create the therapeutic effect generated by the emission of focused ultrasound.
The third U.S. Patent protects the entire apparatus for treating deep vein thrombosis with focused ultrasounds.
Filling the gap for unmet medical need
The launch of the Cardiawave ultrasound device is poised to be a major breakthrough in the treatment of heart diseases, particularly aortic stenosis (AS), the most common heart valve disease in adults.
This non-invasive medical device has been designed to provide a safe and effective treatment for AS, which is currently an unmet medical need.
A large number of patients diagnosed with severe Aortic Stenosis in their 80s are not treated in the USA, with about 78% aged 70-79 and 84% aged 80-89, representing approximately 200,000 untreated patients in their 80s, cites the company in a press release.
The Cardiawave’s ultrasound device offers a non-invasive alternative to surgical interventions, such as transcatheter aortic valve replacement (TAVR).
The company claimed that this technology has the potential to improve patient outcomes, extend lifespans, and reduce healthcare costs by offering a safe and effective non-invasive alternative.
Furthermore, the launch of the Cardiawave ultrasound device offers a reprieve for the population, particularly for patients with severe symptomatic aortic stenosis (AS) who do not undergo treatment.
According to a study cited by the company, these patients cost Medicare as much as US$1.3 billion each year due to rehospitalization, prolonged stays, admissions to skilled nursing facilities, and the use of hospice care.
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