UPDATE: Aug. 16, 2019: FDA Friday approved Edwards' SAPIEN 3 Transcatheter Heart Valve THV System and Ultra THV System for patients with low risk for surgical therapy. A study published in the New England Journal of Medicine in March showed TAVR with Edwards' device was superior to conventional surgery in preventing death, stroke and repeat hospitalization at one year in 1,000 severe aortic stenosis patients.

Dive Brief:

• Edwards Lifesciences has received FDA approval for its Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) system.

• The newly-approved system is based on Edwards’ existing Sapien 3 transcatheter heart valve but features a redesigned valve and delivery system.

• Edwards thinks the changes will simplify the TAVR procedure and thereby enable it to retain its strong position in a fast-growing market despite competition from Boston Scientific and Medtronic.

Dive Insight:

Edwards enters 2019 with aspirations to grow its TAVR sales by 11% to 15%. To achieve that goal, the broader TAVR sector will need to maintain momentum and Edwards must retain a significant slice of the market. Sapien 3 Ultra is part of Edwards’ strategy for ensuring those things happen, although its impact on the financial results will only be fully felt in 2020 and beyond.

In designing the system, Edwards has taken its existing Sapien 3 technology and modified it with a view to simplifying TAVR procedures. The result is a redesigned valve with changes such as a 40% increase in the outer skirt height, plus a new lower profile delivery system. Collectively, Edwards thinks the changes will reduce procedural steps and manipulations.

The revised procedure is intended to help physicians and thereby increase use of Edwards’ products. However, in the near term the procedural changes may restrict uptake of the Sapien 3 Ultra system.

Edwards plans to undertake a "controlled rollout" of the system to ensure physicians are familiar with it and how it differs from its predecessor before they start using the device. The strategy will see Edwards' clinical specialists train physicians on the differences between the devices and procedures to ensure it retains existing patient success rate when moving to the new system.  

The strategy could benefit patients by ensuring physicians effectively use Sapien 3 Ultra from day one and help Edwards’ business in the medium term. However, the controlled rollout means Edwards expects the approval of Sapien 3 Ultra to have minimal impact on its financial performance in 2019.  

Edwards expects sales of the device to gradually increase throughout the year and properly ramp up beyond that. The timeline means the emergence of Sapien 3 Ultra will cover a key period for Edwards and the broader TAVR sector. In March, Edwards plans to share data on TAVR in low-risk surgical patients that could set it up to target a broader patient population by the end of the year.