- Edwards Lifesciences on Monday said it received regulatory approval in China for its Sapien 3 transcatheter heart valve as an alternative treatment for patients with severe aortic stenosis who are at high risk for open heart surgery.
- Approval by China's National Medical Products Administration was based on a Sapien 3 study in the country that followed Edwards' three randomized controlled Partner studies, which previously supported U.S. approvals.
- Markets in Asia have been slow to adopt transcatheter valve treatments due to high costs associated with performing the procedure, as well as the need for specific training and lack of specialized heart teams, a 2018 article in the Journal of the American College of Cardiology said. But rising life expectancies in the region are driving demand for new treatments for cardiovascular disease.
China represents just a small percentage of Edwards' current sales, but the company has been patiently laying the groundwork in anticipation of a key long-term market opportunity. CEO Michael Mussallem, in a 2017 article for EY Global, talked about Edwards' approach for gaining access to the Chinese market, emphasizing the introduction of "differentiated" products, rather than developing lower-cost, streamlined versions of its technologies.
Part of Edwards' strategy has involved moving experienced employees to China from other locations to provide initial guidance on best practices, with the ultimate aim of lessening reliance on an expatriate presence, Mussallem said.
Edwards cut its 2020 sales outlook in April due to a slowdown in elective procedures as healthcare providers shifted attention to battling the COVID-19 pandemic. The company was forced to pause the rollout of the latest iteration of its Sapien transcatheter aortic valve replacement (TAVR) device at centers not already trained on its use.
Still, the year was off to a strong start for Edwards before the pandemic hit, with TAVR sales buoyed by an expansion of the patient pool for the devices to include people at low risk for open heart surgery. The company said it was expecting a rebound in procedure growth to begin in the third quarter as surgeries are rescheduled.
Frost & Sullivan last year pegged the Asia-Pacific region as on track to overtake Europe as the second-largest regional medical technology market by 2022. Edwards expects countries beyond the U.S., EU and Japan to roughly triple their slice of the company's total sales in the next five years, with China's access to Edwards' devices increasing as the nation's wealth grows.
In setting its sights on the Chinese market, Edwards will face competition from domestic manufacturers encouraged by the country's ambition to become a leading global medical device producer rivaling the United States. In April 2017, China's Venus Medtech became the first TAVR device to win regulatory approval in the country with its VenusA-Valve.
Edwards' Sapien 3 valve will be introduced via the company's global training program in hospitals throughout the nation and will be available in 20mm, 23mm, 26mm and 29mm sizes.