Toray Industries Launches Novel Catheter for Treating Aortic Valve Stenosis in the United States

Toray announced that it officially began sales in the United States in July of a new catheter for the treatment of aortic valve stenosis. The company has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its “Inoue Balloon for Aortic Valve” catheter for balloon aortic valvuloplasty, and is marketing it in the U.S. under the name “INOUE BALLOON A.” Toray has been selling catheters for mitral valve stenosis in the United States for over 30 years, and this newly launched catheter is the company’s next product line following that. The Inoue Balloon for aortic valves has been sold in Japan since 2018, and has achieved a cumulative usage of over 10,000 units in medical institutions.