Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has successfully performed a difficult-to-treat 'valve-in-valve-in-valve' procedure with its DurAVR™ transcatheter aortic valve replacement (TAVR) system — a novel first-in-class biomimetic valve made from a single piece of native-shaped tissue.
The patient, who was receiving a third valve replacement, or valve-in-valve-in-valve procedure, has been treated at the Karolinska University Hospital in Stockholm, Sweden, by Dr Andreas Rück, Dr Magnus Settergren and Dr Nawzad Saleh.
The patient had previously received a surgical valve, which failed after seven years. It was replaced by inserting a TAVR valve inside the surgical valve six years ago, but that had also failed leading to the patient becoming severely debilitated due to his valve disease and in need of a viable third solution.
This patient was deemed unsuitable (or at extreme risk) for a surgical intervention, while commercially available TAVR devices would not provide meaningful benefit to the patient.
The heart team determined that DurAVR™ would offer the only alternative in this case. With the DurAVR™ in clinical trial phase of development, compassionate use approval was sought, granted and the patient has now been successfully treated.
"Impressed with outcome"
Dr Andreas Rück said, “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.”
Dr Magnus Settergren said, “The patient had already had both a surgical valve and a TAVR 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 TAVR in failed surgical valves and failed TAVR valves.”
Dr Chris Meduri said: “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 hemodynamics 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 TAVR 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.”
Anteris CEO Wayne Paterson said, “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."