Following the news that Edwards Lifesciences has received Chinese regulatory approval for its SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery;

Ashley Young, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:

“The global market for transcatheter aortic valve replacement/implantation (TAVR, or TAVI) has been witnessing growth in recent years. GlobalData estimates that the global market value of TAVR devices was approximately US$3.5bn in 2019, with high compound annual growth rates (CAGRs) in many countries. GlobalData predicts that the TAVR market in the US alone will grow at a CAGR of 19.7% between 2019 and 2028.

“The Sapien 3 valve by Edwards Lifesciences is a widely-used valve in many countries around the world. Edwards dominates the TAVR market in North America with its Sapien line of valves while it shares the market largely with main competitor Medtronic (Evolut brand of valves) in the European region. In the Asia-Pacific (APAC) region, the Sapien valve is already popular in countries such as Japan and Australia.

“Until now, China has relied on local manufacturers such as Venus MedTech for the supply of TAVR valves. In addition, the adoption of TAVR procedures has been historically low in the country, with GlobalData estimating a very low procedure volume of just under 300 procedures being carried out country-wide in 2019. 

“The regulatory approval of the Sapien 3 in China will boost the TAVR market in the region, assuming that local physicians take up the brand. Furthermore, regulatory approval for the Sapien 3 comes at a relatively good time for Edwards, as China is relatively far ahead in its recovery from the COVID-19 pandemic, compared to other countries around the world.”