Words To Live By
Edwards Lifesciences 2005 Annual Report"
This year, we continued to advance the state of the art and gained additional
strength in our key growth initiatives. Although we
fell short of our original sales goals for LifeStent peripheral vascular
stents, we remain optimistic about our differentiated technology and
the overall market opportunity. Preliminary 12-month results from our
Phase I RESILIENT clinical trial showed promise in improving patients’circulation
in the demanding superficial femoral artery, and we
believe these early results bode well for LifeStent’s future success.
Additionally, we made important progress
in the development of our percutaneous heart valve programs.
In the first quarter, we initiated a U.S. IDE clinical
trial for our Cribier-Edwards percutaneous aortic heart
valve, which uses a catheter delivery system to navigate
the replacement valve through the patient’s circulatory
system instead of taking a surgical approach. We voluntarily
suspended the study at mid-year in order to incorporate
a new delivery system, which had reduced procedural complexity
and improved clinical outcomes in cases outside the U.S.
We were very pleased to have restarted patient cases by
the end of the year.
In our two percutaneous mitral heart valve
repair therapies, we incorporated a number of product enhancements,
and clinical feasibility cases were underway at Canadian
and European sites by year-end.
We believe percutaneous heart valve therapies
offer hope to thousands of patients worldwide who
are not good candidates for conventional open-heart
valve surgery and face limited therapeutic options. With
the experience gained this year, we are well-positioned
for clinical progress in all of our percutaneous
valve programs in 2006.
