Key highlights
- The Inoue Balloon A treats aortic valve stenosis.
- FDA 510(k) clearance was obtained for the device.
- Prevalence of aortic stenosis is 2.8% in ages 60-74 and 13.1% in 75+.
- Estimated 5.03 million potential patients in the US.
Product Launch
Toray Industries has launched the Inoue Balloon™ for Aortic Valve, known as Inoue Balloon™ A in the U.S., following FDA 510(k) clearance. This device is designed for treating aortic valve stenosis.
Medical Context
Aortic valve stenosis is a condition where narrowed valve openings hinder blood flow. It affects 2.8% of individuals aged 60-74 and 13.1% of those 75 and older. Toray estimates 5.03 million potential patients in the U.S.
Device Background
The Inoue Balloon™ A shares design features with Toray's existing mitral valve stenosis treatment, the Inoue Balloon™ Catheter, available in the U.S. since 1994. The new device has been used over 10,000 times in Japan since 2018.
