Laguna Tech USA has 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 transcatheter aortic valve implantation (TAVI) system is a one-piece self-expanding transcatheter valve engineered with a low profile valve and delivery system, with six support arms for 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 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 Tbilisi, Georgia.
Scott Lim (University of Virginia, Charlottesville, USA), The primary investigator in the study, said: “The Laguna Tech USA Alpha self-expanding aortic valve and Zeta balloon-expandable aortic valves performed as designed, allowing us to successfully and percutaneously treat these first patients at high surgical risk with severe aortic regurgitation, and in one case, with concomitant significant calcific aortic stenosis. I look forward to these novel transcatheter aortic valves being further investigated in larger studies, as this initial experience is quite encouraging toward helping us address a significant unmet patient need in those with complex aortic valve disease.”
Cristian Dauvergene (Instituto Nacional de Torax, Santiago, Chile), added: “We were able to successfully implant the Zeta aortic valve very simply and efficiently aided by the low profile and straightforward transcatheter implantation allowing for advantageous placement in the heart. We are excited to be a part of the success of the first procedure of this important next-generation TAVI system, and we look forward to participating in Laguna Tech USA’s clinical study.”
“With this successful groundbreaking first in human clinical experience with the Zeta valve and the additional successful Alpha valve implants, we have a growing body of evidence supporting the promise of our next-generation, differentiated aortic valves, which represent much-needed advancement in the field,” said Gilbert Madrid, chief executive officer of Laguna Tech USA. “Specifically, our valve designs are intended to address an unfortunate, longstanding gap in the applicability of heart solutions because of rigid and unyielding technology designs that eliminate many patients as prospective candidates. With two varying valve designs, each leveraging advanced technology and engineering of existing products on the market, we look forward to the potential of our technology to significantly expand the number of patients with aortic valve regurgitation who may be treated with our minimally invasive treatment options.”