Feasibility data on the Multi-Link Vision cobalt-chromium, durable-polymer, everolimus-eluting stent will be key to predicting the stability of Guidant's DES technology platform in the post-Dollens era.

During the Bear Stearns Healthcare Conference in New York Sept. 14, outgoing President & CEO Ron Dollens said: "I am absolutely convinced that we will have good clarity by the end of the year in terms of how robust the [drug-eluting stent] business is for Guidant. I don't want to leave until that cloud gets cleared."

Clinical results of Guidant's 60-person SPIRIT-FIRST trial might be available in time for the Transcatheter Therapeutics Conference conference in Washington, D.C. Sept. 27-Oct. 1, the exec noted. The study, which measures in-stent "late loss" at six months, would support an IDE filing for a pivotal trial.

At Bear Stearns, Dollens characterized the feasibility trial as central to clarifying Guidant's DES prospects between October and his planned exit date of Dec. 31. "Within three weeks, we should be able to know" the clinical and regulatory timeframe of our Vision DES platform, "and that is going to be important."

Vascular Intervention President Dana Mead added that by 2005, Guidant can also expect better clarity on how manufacturing process refinements to its Champion bioabsorbable-polymer, everolimus-eluting stent will affect the product's "scalability."

Champion's launch was delayed by more than six months because the device had to be redesigned to fix a propensity for stent fracture in the link connecting the stent ring (¹ Also see "Guidant To Push DES Program In 2005, Says Champion Fracture Issue Solved" - Medtech Insight, 30 August, 2004., p. 10).

Guidant anticipates Champion's introduction to the U.S. market early in 2007, with Vision making its domestic debut in the middle of that year. For 2007, the firm estimates the total DES market size at $6 bil.

Dollens considered Champion's manufacturing setback and the failed merger with Cook in the context of enforcement threats that Boston Scientific and Johnson & Johnson/Cordis recently have experienced.

The DES marketplace is "obviously not just a roll-over slam-dunk, as has been proven by most of the players [and] has been proven by us more than most," he acknowledged.

The SPIRIT-FIRST results could mark a turning point in the relationship between Guidant and J&J, which currently market Cordis' Cypher sirolimus-eluting stent and plan to put the next-generation device on the Multi-Link Vision stent delivery system (² Also see "Cypher Revenue Stream Counters Some DES Damage To Guidant Stent Sales" - Medtech Insight, 26 April, 2004., p. 6).

Positive feasibility data could encourage J&J to more closely examine Guidant as an acquisition target.

Conversely, Dollens speculated that if a "worst-case" scenario emerges and the trial finds everolimus does not work, Guidant's co-promotion deal for Cypher likely will assume greater significance.

"It is only when [Cypher is] a 50% player in a two-horse race - and it is on the next-generation product" - that the economics of the J&J marketing agreement would "be good enough for the public to be interested," Dollens stated.

"Our 'commission rate' increases substantially based on share attainment of Cypher," and Cypher on Vision would "be a much more competitive product, so the share could go up [while Guidant] gets a higher OEM fee" at the same time, he reasoned.

"We made the [co-marketing] deal last through 2011 just to make sure that we could screw-up one or two more times and we would still be okay," he quipped.

Asked if Guidant should remain a stand-alone firm after he leaves, Dollens said: "If Guidant is part of a larger organization, the sense of urgency, the focus and the accountability would be less." Still, "the flip-side is: are you entering areas where scale, critical mass [and] different levels of breadth are important?"

He asked rhetorically: "If you think near-term, do we have the ability to do" drug-eluting stents and cardiac resynchronization therapy with implantable cardiac defibrillators alone? "Yes, we do," he concluded.

When one asks "of the two firms - Boston Scientific and J&J - which one has had the most success in terms of drug-eluting stents, you say, 'Gee, it wasn't the pharmaceutical company,'" he remarked.

Dollens, who expects to name his successor in October, has accepted the Harold A. "Red" Poling Chair of Business & Government at Indiana University's Kelley School of Business. Besides teaching, Dollens plans to engage in venture capital consulting.

Guidant Awaits SPIRIT Trial Data For Clear Vision Of Future Stent Business

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