Anteris Technologies has announced the successful completion of a case involving a patient receiving a third valve replacement—a valve-in-valve-in-valve procedure—at the Karolinska University Hospital in Stockholm, Sweden.
Performed by Andreas Rück, Magnus Settergren and Nawzad Saleh, the case involved Anteris’ DurAVR biomimetic transcatheter heart valve system.
The patient had previously received a surgical valve, which failed after seven years, and was replaced by transcatheter aortic valve implantation (TAVI) inside the surgical valve six years ago, but had now failed and led to the patient becoming severely debilitated due to his valve disease and in need of a viable third solution.
The heart team deemed the patient unsuitable (or at extreme risk) for a surgical intervention. The team determined DurAVR would offer the only alternative in this case and compassionate use approval was sought, granted and the patient has been successfully treated.
Rück stated: “We are impressed with the outcome in this very difficult to treat patient. DurAVR allowed us to treat a patient who was deemed unsuitable for surgical intervention or in fact other TAVRs. The device was easy to use and allowed us to implant the valve in a predictable way. Further, it has provided the patient with the best functioning valve since before his first valve replacement, this despite it being placed inside two other valves. We were pleased to see that the remarkable performance previously seen in native aortic stenosis and valve-in-valve, even delivers in the challenging valve-in-valve-in-valve cases.”
Settergren further commented: “The patient had already had both a surgical valve and a TAVI placed inside the surgical valve in the past years to treat their aortic stenosis. Both valves had failed leaving the patient with no alternatives. The DurAVR allowed us to get a result no other available valve could offer. It worked well in a challenging environment and the patient is feeling much better. This will be an important valve, not just for native aortic stenosis but also in the complex TAVI in failed surgical valves and failed TAVI valves.”
“We are pleased that even in the most challenging settings we are giving patients viable solutions to their disease. The outcome in this difficult to treat setting where other therapies were deemed unsuitable is further testimony to the unique profile of DurAVR as a first in class biomimetic valve”, said Wayne Paterson, CEO of Anteris.
Chris Meduri (Karolinska University Hospital, Stockholm, Sweden), chief medical officer for Anteris, who presented an early feasibility and first-in-human trial update for the DurAVR valve at EuroPCR 2024 (13–17 May, Paris, France), commented: “The impact of biomimetic technology is seen in a wide variety of patients. We have clearly demonstrated in our clinical trials that in native aortic stenosis patients we are achieving normalised pre-disease haemodynamics as well as normal flow beyond what has been achieved in the past. It is well recognised that valve-in-valve is a growing phenomenon and estimated that in the near future 30% of the TAVI market will be patients needing a second replacement. The company is pleased that it is aiming to offer a valuable alternative product for first line treatment, as well as a viable solution for patients who will need a second valve replacement.”
