Inspiris Resilia valve
To extend the durability of the Inspiris Resilia surgical aortic valve, Edwards Lifesciences (EW) has incorporated a new tissue platform, Resilia tissue, with a high anti-calcification property. The valve also involves an expandable frame called vFit technology with size markers, making it suitable for future valve-in-valve procedures. This valve is the only transcatheter aortic valve replacement compliant valve currently in the market, which is a strong competitive advantage. Edwards Lifesciences competes with other surgical aortic valve replacement players such as Abbott Laboratories (ABT), Medtronic (MDT), and Boston Scientific (BSX).
FDA (U.S. Food & Drug Administration) approval for Inspiris Resilia was secured on July 5, 2017. It was based on results from the COMMENCE pivotal trial involving 689 patients. Two-year data from this trial, presented at the European Association for Cardio-Thoracic Surgery’s annual meeting in 2016, showed that there was no structural valve deterioration in patients treated with the Inspiris Resilia valve, despite the fact that 21.0% of the tested patients were young and below 60 years of age.
Edwards Lifesciences has been developing the innovative Konect platform for mainly younger congenital patients suffering from multiple cardiac conditions such as aortic valve disease, ascending aorta disease, and aortic root disease.
The company is developing this pre-assembled product by combining the best tissue technology to last longer for young patients with the best graft currently available in the market and best aortic valve in the company’s portfolio.
The company expects its first regulatory approval for this innovative platform in 2018. If the company manages to secure this approval ahead of the projected timeline, it may have a positive impact on Edwards Lifesciences stock and the stock of the iShares Russell 1000 Growth (IWF). Edwards Lifesciences makes up about 0.21% of IWF’s total portfolio holdings.
In the next part, we’ll take a look at Edwards Lifesciences’ clinical programs that target mitral and tricuspid regurgitation patients.