IRVINE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) — Laguna Tech USA, a privately-held medical technology company dedicated to innovations in structural heart solutions to broaden useability and applicability for patients, today announced that the first-in-human clinical case was completed with the Zeta Balloon Expandable Aortic Valve System and additional patients have been successfully treated in the feasibility clinical study of its investigational ALPHA Self-Expanding Aortic Valve system to treat aortic regurgitation. To date, two patients have been successfully treated in the Alpha Aortic Valve study, with both achieving complete resolution of aortic regurgitation immediately following the procedure, which has been maintained at the 30-day follow-up examination.
The ALPHA system is a uniquely designed one-piece self-expanding transcatheter valve engineered with a low profile valve and delivery system, with six support arms for simpler, better positioning within the aortic annulus and cusps. The ZETA system is a novel balloon-expandable transcatheter valve with six expanding arms and a low profile covered delivery system. The six expanding arms allow for simple positioning of the valve into the aortic annulus and cusps.
The feasibility study is being conducted at the Instituto Nacional de Torax in Santiago, Chile, and Tbilisi Heart and Vascular Clinic in Georgia.
