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.

Cardiologist Scott Lim, DO, of the University of Virginia in Charlottesville, Virginia is the lead primary investigator of the trial.

“With the LagunaTech Alpha TAVR valve, designed to treat patients with complex aortic valve disease, including native severe aortic regurgitation as well as calcific stenosis, we were able to successfully treat the first patient,” commented Dr. Lim in the company’s press release. “The Alpha valve performed as intended, from a percutaneous femoral approach and tracking smoothly to the aorta.

“In this complex first patient, with both severe aortic stenosis and regurgitation, implantation of the Alpha valve resulted in complete resolution of the aortic valve disease. The Alpha valve’s commissural alignment system worked well, as demonstrated by simultaneous transesophageal echocardiography, with preserved coronary access.”

He concluded, “Additionally, the unique anchoring mechanism, which allows the Alpha valve to treat severe and noncalcific aortic regurgitation, functioned as intended. This first-in-human experience is encouraging, and I look forward to further cases in the early feasibility study.”

The company stated that the Alpha TAVR device is designed to restore heart function by placing support arms in the aortic cusps and placement of the valve within the annulus. The valve self-expands into the annulus to form a new functioning valve and seals at the annulus to prevent paravalvular leak. The system is engineered with a design and pliable materials that provide versatility, flexibility, and positioning of the device in the annulus for improved placement within the patient.

The self-expanding Alpha system is the company’s lead investigational device. Laguna Tech’s Zeta aortic valve, which is a balloon-expandable valve for aortic regurgitation, and the iNValve mitral and tricuspid valve, which is a transseptal valve, are in preclinical development, advised the company.