Edwards Lifesciences Corporation (EW) has received conditional Investigational Device Exemption (“IDE”) approval from the US Food and Drug Administration (“FDA”) for the next-generation tissue treatment platform, GLX. The GLX platform received CE Mark approval in May 2012.
The GLX technology will be studied on the company’s Perimount Magna Ease Aortic Valve and will be extended to other devices. Safety of the valve and its effectiveness will be the primary endpoints of the trial. The GLX technology is designed to reduce calcification, enable a smaller valve profile and improve ease of use.
Edwards is working on expanding its structural heart valve portfolio. Earlier this year, the company received CE Mark approval for Intuity valve system. The product, to be used in patients undergoing surgical aortic valve replacement (“AVR”), facilitates small incision surgery and rapid valve deployment. Two post-approval studies, Cadence and Foundation, will begin in Europe. These studies will focus on the benefit of patients and health economics of this device compared to traditional open heart surgery. Revenue contribution from Intuity though projected to be modest this year will pick up next year. The company has begun enrollment for Triton II, a clinical study of the next-generation Intuity system, which features enhancements to both the delivery system and the valve.
While the IDE approval for the GLX platform is good news for the company, current investor focus will remain on the outcome of the advisory panel (scheduled on June 13) regarding approval of Edwards’ Sapien transcatheter heart valve (“THV”) for high risk surgery patients. Several issues have been highlighted by the FDA reviewers which invite caution. The device was approved in November 2011 for patients considered unfit for AVR.
The development of the Sapien portfolio holds immense potential for Edwards as it provides surgeons the option to eliminate the necessity of open heart procedures. While the company has the first mover advantage in the US with its launch of Sapien in November 2011, the scenario in Europe is competitive with the presence of Medtronic (MDT) and other players. Boston Scientific Corporation (BSX) is also geared to enter the transcatheter aortic valve market.
We have a Neutral recommendation on Edwards. The stock retains a Zacks #3 Rank (hold) in the short term.
To read this article on Zacks.com click here.
