Next Drug Stent Trials: Medtronic Goes to Europe, Guidant Stays Home
Medtronic and Guidant need to play catch-up in the stent race to see who's going to be third behind Cordis/J&J's Cypher, which is approved in the US, and Boston Scientific's Taxus, which is expected to be approved shortly. A key component of Medtronic's and Guidant's competitive strategies will be deciding whether to do trials in the US vs. doing them internationally. Medtronic is doing its pivotal study in Europe, while Guidant is doing its in the US.
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While the greater efficacy of drug-eluting stents (DES) compared to bare-metal stents is widely accepted, over the past year, data has continued to build showing that first-generation DES also have a higher late-stage in-stent thrombosis risk, a complication that can cause death 30% of the time, according to some estimates. The findings of these studies had some physicians at this year's World Congress of Cardiology calling for "an immediate halt to DES overuse." However, most conceded that additional randomized trials will be needed to fully understand the potential risks associated with these devices.
Biosensors International has not only developed a new stent, coating, and delivery technology in-house, but has also come up with its own drug, a rarity among small stent companies. Biosensors has adopted an aggressive dealmaking strategy much more akin to a large device or drug company, than a small firm. The result is that Biosensors has entered into alliances with big companies, including Guidant, and start-ups that have turned what until recently was a small interventional cardiology OEM company into one of the most innovative players in the drug-eluting stent market.
As it seeks to capitalize on new opportunities in both its CRM and interventional businesses, Guidant also confronts a device industry whose rules are changing. The second of a two-part series.