Laguna Tech USA Begins FIH Trial of Alpha TAVR System

June 21, 2023—Laguna Tech USA announced that the first patient has been treated in the first-in-human clinical trial of the company’s investigational Alpha transcatheter aortic valve replacement (TAVR) system to treat aortic regurgitation. Laguna Tech is a privately-held medical technology company with headquarters in Irvine, California.

According to the company, the Alpha TAVR system is a one-piece, low-profile valve engineered with a small diameter, delivery system control, and multiple support arms for simple positioning within the aortic annulus and cusps.

The company reported that the first patient to receive the Alpha device achieved complete resolution of aortic regurgitation immediately after the procedure, which was maintained at the 30-day follow-up examination. The feasibility trial is being conducted at the Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia.


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