- Patient with aortic regurgitation achieves complete resolution of regurgitation immediately following procedure, which was maintained at the 30-day follow up
- First-in-class, low profile one-piece self-expanding ALPHA Aortic Valve System engineered to optimize positioning and placement of valve using a percutaneous transfemoral approach
- Versatile design of valve and delivery system expected to significantly broaden patient eligibility for implant
IRVINE, Calif., June 21, 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 announce that the first patient has been treated in the first-in-human clinical trial of its investigational ALPHA Aortic Valve system to treat aortic regurgitation.
The ALPHA system is a uniquely designed one-piece valve engineered with a smaller diameter and delivery system control, and multiple support arms for simpler, better positioning within the aortic annulus and cusps. The first patient to receive this novel device achieved complete resolution of aortic regurgitation immediately following the procedure, which was maintained at the 30-day follow-up examination. The trial is being conducted at the Tblisi Heart and Vascular Clinic in Georgia.
The lead primary investigator, Dr. Scott Lim, a cardiologist from the University of Virginia noted, “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. 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. Additionally, the unique anchoring mechanism which allows the Alpha valve to treat severe and non-calcific aortic regurgitation, functioned as intended. This first-in-human experience is encouraging, and I look forward to further cases in the early feasibility study.”
“It’s hugely rewarding to see the successful completion of the first-in-human procedure with our ALPHA Aortic Valve,” said Gilbert Madrid, chief executive officer of Laguna Tech USA. “As veterans in the cardiovascular space, we have seen the longstanding and unfortunate gap in applicability of innovative heart solutions because of rigid and unyielding technology designs that eliminate many patients as prospective candidates. 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 option.”
About the ALPHA Aortic Valve System
The ALPHA Aortic Valve 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 was invented at Laguna Tech USA with the first prototype entering preclinical development in 2022. The system is engineered with a unique design and more pliable materials to increase the versatility, flexibility and positioning of the device in the annulus for improved placement within the patient.
About Laguna Tech USA
Laguna Tech USA is a privately held medical technology company focused on providing innovative, less invasive structural heart solutions to a significantly expanded group of patients who previously were excluded as candidates for valve replacements. Laguna Tech USA believes its highly differentiated next generation engineering offers versatility and flexibility, and therefore feasibility, of its valves in addressing diverse heart conditions across a broad population of patients. The company’s lead investigational device, the ALPHA Aortic Valve, is a self-expanding valve for aortic regurgitation. The ZETA Aortic Valve, in preclinical development, is a balloon expandable valve for aortic regurgitation. In addition, the iNValve Mitral and Tricuspid valve is a transseptal valve in preclinical development.
Contact
Sylvia Wheeler
Investor Relations and Corporate Affairs
swheeler@wheelhouselsa.com
