Laguna Tech Reports on Zeta TAVR System’s FIH Feasibility Trial

January 3, 2024—Laguna Tech USA announced that the company’s Zeta balloon-expandable transcatheter aortic valve system is being evaluated in a first-in-human clinical trial.

The company reported that the Zeta device was used to treat five patients with aortic valve disease on the same day at a single center, Instituto Nacional del Torax in Santiago, Chile. The procedures were conducted within the ongoing feasibility trial for the Zeta system.

All patients achieved complete resolution of aortic disease with no residual stenosis or regurgitation immediately after the procedure and were discharged within 24 to 48 hours of the procedure.

According to Laguna Tech, the volume of procedures was made possible by the versatility and flexibility of the design of the Zeta system, which is intended to provide ease of implantability for a broad patient population.

Christian Dauvergne, MD, Chief of Interventional Cardiology at Instituto Nacional del Torax, and Scott Lim, MD, the study’s lead Primary Investigator and a cardiologist at the University of Virginia in Charlottesville, Virginia, discussed the procedures in Laguna Tech’s press release.

“Our ability to successfully implant the Zeta aortic valve in five patients with complex, diverse clinical profiles on a single day was due to the very simple and efficient design characterized by a low profile and straightforward transcatheter system, which allows for simple, advantageous placement in the heart,” commented Dr. Dauvergne in the press release. “I look forward to the continued development of the Zeta device to explore the potential of this breakthrough technology to treat more patients with aortic regurgitation with unmet needs.”

Dr. Lim added, “The treatment of complex and diverse aortic valve disease patients at the center in Santiago was an impressive accomplishment, as was the highly reproducible landing of the Zeta valve relative to the aortic annulus, regardless of the degree or lack of calcium, which speaks to the potential of the balloon-expandable Zeta aortic valve.”

Dr. Lim continued, “We treated patients both with severe, noncalcific aortic regurgitation as well as those with highly calcific aortic stenosis, and in all cases, there was no paravalvular regurgitation. Additionally, by fluoroscopy, all implanted Zeta valves were consistently implanted within two millimeters of the annulus. I look forward to the upcoming pivotal clinical trials on the Zeta valve.”