Cook Hopes Biliary Stent Data Will Break Boston Scientific's Dominance

Full article reprinted from "The Gray Sheet" - December 7, 2009

Armed with data showing that its Zilver 635 self-expanding biliary stent measures up to Boston Scientific's market-dominating Wallstent , Cook Medical hopes to carve out a larger share of the $90 million segment. Read more...

Cook Hopes Biliary Stent Data Will Break Boston Scientific's Dominance

Full article reprinted from "The Gray Sheet" - December 7, 2009

Armed with data showing that its Zilver 635 self-expanding biliary stent measures up to Boston Scientific's market-dominating Wallstent , Cook Medical hopes to carve out a larger share of the $90 million segment.

Wallstent has a 70% market share, compared to the 10%-15% share held by the Zilver franchise, according to Cook.

Since its 2001 launch, Zilver has lagged behind Wallstent, but the company believes data from its MOZART trial will change the dynamics.

"We now have clinical proof that the Zilver stent has the equal patency ... to the gold standard [Wallstent]," Fritz Haller, director of product management for Cook Endoscopy, said in an interview.

MOZART included 241 patients presenting with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. The primary endpoint was death or stent occlusions requiring reintervention.

Subjects received 6 mm or 10 mm nitinol-based Zilver 635 stents or a 10 mm stainless steel Wallstent.

The 6 mm version did not measure up to Wallstent, but 10 mm version did, Cook reports.

The mean number of days of stent patency for the 10 mm Zilver was 185.8 compared to 186.7 for Wallstent.

Stent occlusions occurred in 23.9% of patients in the 10 mm Zilver arm and 21.4% in the Wallstent group.

Launched in May, Zilver 635 is the only biliary stent on the market that is delivered on a 6 French introducer, according to Cook. The introducer is made from a proprietary Flexor coil-reinforced technology, which adds to its flexibility, the firm claims. The Wallstent, by contrast, uses a larger 8 French introducer.

Because of its small size and flexibility, physicians can place two Zilver introducers in the channel of an endoscope, giving them the option to stent both sides of the liver, Haller explained. "That's a real clinical advantage," he said.

Haller also claims that Cooks sells Zilver 635 for 10%-15% less than Wallstent's average price tag.

- Brooke McManus

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