A Medical Device Daily

Boston Scientific (Natick, Massachusetts) yesterday reported receiving conditional approval from the FDA for its Taxus Liberté drug-eluting stent (DES).

“We have an approvable letter for Taxus Liberté, and we hope to receive final approval shortly after our corporate warning letter is lifted, which we expect to be around the middle of the year,” said Paul Donovan, spokesman for Boston Scientific.

The warning letter – issued in early 2006 — has prevented the company from winning approvals of new products, and inspections designed to lift it have been ongoing since February of this year.

Commenting on Boston Scientific’s report of the conditional approval, analyst Rick Wise of Bear Stearns issued a note saying the company has said it expects warning letter removal in mid-year, followed by launch of the Liberté.

But the note says Bear Stearns assumes a more conservative timeline and expects the removal in the third quarter.

The Liberté will be positioned to go up against the second-generation DES devices, primarily the Endeavor DES from Medtronic (Minneapolis), and the Xience from Abbott Laboratories (Abbott Park, Illinois), which has received an FDA panel recommendation and is expected to be notified of FDA approval fairly soon.

The Bear Sterns note said that Boston Scientific has reached a “turning point” in its operations, but “we remain on the sidelines until we get more clarity on the competitive dynamics in the DES market and the impact of the newly-launched CRM [cardiac rhythm management] products.”