Queensland-based medical technologies company, Admedus, has announced new progress in the development of its patented Transcatheter Aortic Valve Replacement (TAVR) project, having successfully implanted its unique single-piece aortic heart valve in a sheep.
The company announced that the successful animal trial, conducted in by Admedus partnership with a leading European reference laboratory, marks a critical point in the development roadmap into humans.
TAVR is where a valve is placed into the heart via a catheter (usually inserted through the leg) to replace the aortic valve, eliminating the need for open-heart surgery.
Admedus’ unique 3D single-piece moulded valve offers greater precision deployment and placement mechanisms which allow the surgeon to achieve a more optimal fit and reduce the risk of paravalvular leakage.
The experimental study follows on from the company’s successful lab tests in which multiple 3D valves were run out to 400 million cycles (approx. 10 years of human use), with a competitor valve as a control. Whilst the Admedus valves remained functional after 400 million cycles, the competitor valve showed significant fatigue at 250 million cycles.
The first single-piece valve was implanted today, officially marking the start of the trial period, which is expected to last for approximately five months, and will involve multiple animals, before extending to larger animals (calves) for testing the valves in a TAVR setting.
“Today is a significant step for the TAVR project as we move into the next stage of development. It was exciting to observe the first-ever of our unique single-piece valves being placed inside a living heart. These experiments are being conducted by global leaders in the field and will provide critical insight for our Development team as we accelerate towards product commercialisation,” Admedus CEO Wayne Paterson said.
Admedus pioneered the proprietary ADAPT® technology, invented by Professor Leon Neethling, which is used to manufacture biomaterial scaffolds.
ADAPT® products – sold globally under the product names CardioCel, CardioCel Neo, CardioCel 3D and VascuCel – are currently used by surgeons around the world to treat patients with congenital heart defects and those in need of heart valve, vessel and cardiovascular repairs and peripheral vascular reconstruction.
By utilising the ADAPT technology, Admedus will offer the first and only TAVR, with proven resistance to calcification and superior biomechanical control capabilities. This revolutionary combination of advantages, provide strong scientific rationale for Admedus TAVR to deliver predictable and improved outcomes.
Admedus currently has multiple patent applications relating to its TAVR device pending in the United States.