Edwards Lifesciences Corporation
) can now initiate the Transform trial in the US with the
conditional Investigational Device Exemption ("IDE") from the Food
and Drug Administration ("FDA"). The trial will evaluate the
company's Intuity valve system in surgical aortic valve replacement
("AVR") procedures. The timeliness of the trial initiation keeps
intact the company's expectation of a mid-year approval.
The single-arm Transform trial is expected to enroll
approximately 500−700 patients, a size typically followed by other
heart valve trials. The Intuity valve is designed to facilitate
small incision surgery and rapid valve deployment to speed up
Although Edwards has yet to fetch an FDA nod for Intuity in the
US, it received CE Mark approval in February 2012. The company also
initiated two post-approval studies in Europe - Cadence and
Foundation - focused on the patient benefits and health economics
of this device compared to traditional open heart surgery. Revenue
contribution from Intuity in the current year will be modest,
which, however, will increase in the coming year.
The company has also begun enrollment of Triton II, a clinical
study of next-generation Intuity system, which features
enhancements to both the delivery system and the valve.
received conditional IDE from the FDA for the next-generation
tissue treatment platform, GLX, last month. GLX 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
Surgical heart valves, contributing 38% to the top line,
recorded a 2.2% year-over-year growth in sales to reach $176
million. The 6.6% growth of surgical heart valves in the
international market was on the back of penetration of the
company's premium products in Europe and Japan. Performance in the
US was adversely affected by the introduction of
St Jude Medical
) pericardial valve, Trifecta, last year. The situation is expected
to improve later this year with the completion of one year of St.
Jude's device. We believe that the company's initiatives to expand
its surgical heart valve portfolio should boost revenues in the
We have a Neutral recommendation on Edwards. The stock carries a
Zacks #3 Rank (hold) in the short term.
EDWARDS LIFESCI (EW): Free Stock Analysis
ST JUDE MEDICAL (STJ): Free Stock Analysis
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