Jul 13, 2018 | By Thomas

Queensland-based medical technologies company, Admedus, has announced new progress in the development of its patented Transcatheter Aortic Valve Replacement (TAVR) project. The company has commenced animal trials by completing the first successful live implantation of its unique 3D printed single-piece aortic heart valve in a sheep.

Admedus successfully tests its 3D printed heart valve device. Image credit: www.admedus.com

Admedus has partnered with a leading European reference laboratory to conduct the “Experimental assessment of the Admedus valve - ovine model of aortic valve replacement” study which is using sheep to examine the safety and feasibility of Admedus’ unique 3D printed single-piece moulded valve in a living subject.

TAVI stands for Transcatheter Aortic Valve Replacement and is a minimally invasive procedure that helps to repair a damaged aortic valve. The TAVR approach delivers a fully collapsible replacement valve to the valve site through a catheter, eliminating the need for open-heart surgery.

Admedus’ unique 3D printed 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 yesterday officially marking the start of the trial period, which is expected to last for around 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," Admedus CEO Wayne Paterson said. "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.”

The company had previously submitted patent applications for a unique 3D printed, single-piece molded valve, using its novel ADAPT tissue technology. Invented by Professor Leon Neethling, The ADAPT tissue technology is used to manufacture durable, bio-compatible scaffolds for soft tissue repair.

By utilizing 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.

The demand for TAVR devices is growing rapidly - current market value is estimated at US$3.5 billion and expected to increase to US$5 billion by 2020. “This device has the potential to be a game-changer for patients, the Company and the TAVR market,” Mr Paterson added.

Admedus currently has multiple patent applications relating to its TAVR device pending in the United States.



Posted in 3D Printing Application



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