Edwards Lifesciences has announced the TGA approval of its SAPIEN 3 transcatheter heart valve for the treatment of severe symptomatic aortic stenosis (AS) independent of their risk score for open-heart surgery.
The company said this latest approval expands access to SAPIEN 3 transcatheter aortic valve implementation (TAVI) for all severe AS patients in Australia.
“This approval gives Heart Teams the option for choosing the best aortic valve replacement strategy based on their patient’s individual needs and allows patients a less invasive alternative to open-heart surgery,” said Associate Professor David Muller, an interventional cardiologist at St Vincent’s Hospital Sydney.
AS is one of the most prevalent and serious valvular heart diseases. It is expected to increase in line with Australia’s ageing population. It is estimated that approximately one-in-eight elderly patients are currently living with AS but it is believed to be underdiagnosed.
Patients with severe AS exhibit a long asymptomatic period but the onset of symptoms is rapid and carries a mortality rate of 50 per cent at two years if left untreated. Studies show at least 40 per cent of severe AS patients do not receive treatment.
“The opportunity to offer TAVI as a treatment option to all severe symptomatic aortic stenosis patients in Australia is a tremendous shift,” said Patrick Williams, managing director of Edwards Lifesciences.
“This is an opportunity for clinicians to consider a less invasive treatment option that has demonstrated excellent patient benefits, including a quicker return to everyday activities, and efficiencies for the broader healthcare ecosystem.”
The company said this latest SAPIEN 3 TAVI indication received a priority review designation approval. The approval is based on data from the PARTNER 3 Trial. It reported a 46 per cent lower event rate for death from any cause, stroke, or rehospitalisation at one year after TAVI compared to open-heart surgery.
Patients also reported significant improvements to health status and quality of life as early as one month after the procedure, said the company.