Edwards Lifesciences Corporation EW recently announced favorable randomized PARTNER 3 trial results. The data showed the effectiveness of the SAPIEN 3 transcatheter aortic valve over surgery.
The SAPIEN 3 valve has been approved by the FDA for treating intermediate and higher risk patients with severe, symptomatic aortic stenosis (“AS”). However, Edwards Lifesciences expects to gain the FDA approval for the low-risk indication in late-2019.
We believe the positive trial outcome will help the company rake in higher revenues from the Transcatheter Heart Valve Therapies (“THVT”) business in the near term.
PARTNER 3 Trial in Detail
Independently assessed, the PARTNER 3 trial compared outcomes between transcatheter aortic valve replacement (“TAVR”) and open-heart surgery in patients with severe symptomatic AS at a low risk of death from surgery. The trial randomized 1,000 patients at 71 centers between Mar 2016 and Oct 2017.
In the PARTNER 3 trial, TAVR with the SAPIEN 3 valve presented an impressively low death and disabling stroke rate of 1.0% at the end of a year in comparison with 2.9% in case of surgery.
Taking the huge potential of the transcatheter heart valve market into consideration, the recent development will help solidify Edwards Lifesciences’ market position. Per a Persistence Market Research report, the global heart valve repair and replacement market is likely to reach a worth of $3,767.0 million in 2020, at a CAGR of 8.7%. Edwards Lifesciences also expects the global TAVR opportunity to exceed $7 billion by 2024.
However, Edwards Lifesciences faces competition from a few imminent players like Medtronic plc MDT, Boston Scientific Corporation BSX and Abbott Laboratories ABT in the niche space. Boston Scientific is gaining from the rising momentum of its ACURATE TAVR valve platform in Europe.
Meanwhile, Medtronic with its CoreValve Evolut TAVR platform comprising CoreValve, CoreValve Evolut R and the CoreValve Evolut PRO systems has maintained its position as a formidable player in the TAVR space.
Furthermore, post the acquisition of St. Jude Medical in 2017, Abbott integrated the popular CE Marked Portico TAVR of the former into its Structural Heart portfolio.
THVT in Focus
In the fourth quarter, Edwards Lifesciences’ THVT sales totaled $592.4 million, up 14.1% from the prior-year quarter. Globally, TAVR procedures continued to deliver growth in the mid-teens. Further, Edwards Lifesciences aims at fortifying its position in Europe with the launch of CENTERA valve, which received CE Mark last February. Also, the company continues with the controlled rollout of SAPIEN 3 Ultra system in Europe and the United States. Edwards Lifesciences continues to see strong TAVR therapy adoption in Japan, driven by SAPIEN 3.
Considering these upbeat factors, Edwards Lifesciences continues to expect underlying TAVR sales growth of 11% to 15% for 2019.
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