Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting.
Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year.
The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said.
The Centera valve won CE Mark approval in the European Union with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery in February.
Leerink Partner analysts noted that despite the expected return, “our checks indicate that EU physicians are resistant to the price premium EW is seeking for Centera, which dampened enthusiasm for adoption once the launch does resume.”
“For EW, both physicians we spoke with noted that Centera was too cost prohibitive and – despite the interventional cardiologist having been part fo the trial – neither would adopt it at their centers,” Leerink analysts wrote in their letter to investors.
Edwards has not yet publicly released information on the pause outside of the EuroPCR meeting.