Long standing in the wings as other players have snared starring roles in the drug-eluting stent (DES) sector in the U.S., Guidant (Indianapolis) yesterday reported the first step in what is essentially an audition leading to hoped-for product commercialization on this very large stage.

SPIRIT III is a large-scale pivotal clinical trial evaluating the safety and efficacy of Guidant’s DES system for the treatment of coronary artery disease.

A prospective, randomized, single-blind trial, SPIRIT III, will compare Xience V, an everolimus-eluting coronary stent system using Guidant’s cobalt chromium Multi-Link Vision coronary stent system platform, vs. the Taxus Express2 paclitaxel-eluting coronary stent system made by Boston Scientific (Natick, Massachusetts).

The results of SPIRIT III “may be used” to obtain FDA approval for Xience V for the treatment of coronary artery disease, Guidant said in a statement.

Steve Tragesh, spokesperson for Guidant, told Medical Device Daily that the “conditional” status of the IDE approval meant only that the FDA is requesting “more information.” And he said that the request “is not going to affect the timeline for enrollment.”

However, he declined to specify either general or specific timelines for trial completion, data analysis, regulatory filings or any other regulatory deadlines estimated by the company, adding that Guidant was not saying much beyond its issued press statement.

Tragesh did say that the company sees the IDE approval as reaffirming “our confidence in these new technology platforms that we’re working on.”

The company’s press statement, for its part, said that both a SPIRIT II and SPIRIT III trial would be launched “in the near future.

Dana Mead Jr., president of Guidant Vascular Intervention, said in the statement: “We are excited to advance the science of drug-eluting stents by partnering with SPIRIT III investigators to generate new clinical data utilizing our Multi-Link Vision-based platform.”

Perhaps to bolster its efforts in the sector, Guidant also said that its initial “presence” in the DES sector in the U.S. came with its early 2004 agreement to co-promote the Cypher DES made by Cordis (Miami Lakes, Florida), a business of Johnson & Johnson (J&J; New Brunswick, New Jersey). Under the terms of the agreement, Guidant co-promotes Cordis’ Cypher DES in the U.S. (MDD, Feb. 24, 2004).

That presence will be sharply expanded, of course, with the planned acquisition of Guidant by J&J in a deal valued at between $24 billion and $25 billion and set to be concluded sometime this year, barring any major regulatory complications. The blockbuster consolidation initially was reported late last year (MDD, Dec. 17, 2004).

The consolidation of the large cardiovascular player with the larger, broader-based healthcare firm obviously provides increased traction for both companies in the DES sector.

It gives Guidant more than just “presence” in the sector, via ties to Cordis’ Cypher product. But Cypher is running second to Boston Scientific’s Taxus DES in market share. And so the Guidant acquisition potentially provides J&J/Cordis another DES platform to do battle vs. Boston Sci – as well as other players expected to tread the boards of the DES stage over the next five years.