Cook Medical's new gastrointestinal tract stent won a pivotal 510(k) clearance, allowing the company to build on a European regulatory nod it gained a year ago.
Today's Medical Developments reports that the company is planning a July U.S. market roll-out for the Evolution Biliary Controlled-Release Uncovered stent. While a 510(k) clearance is often routine in the U.S., the status has become increasingly noteworthy in the context of how companies seek regulatory approvals globally. Cook gained approval for the product in the European Union first, an option that device makers increasingly pursue. The regulatory process is often quicker, and companies can then generate revenue and additional clinical data as they go after U.S. approval--which remains one of the world's most crucial device markets.
As the story notes, the metal biliary stent is designed to relieve bile duct obstructions and resist migration more consistently then competing products. The company also bills its delivery system for the product as one that lets a physician deploy or take back the stent as needed by squeezing a handle trigger.
Cook faced a setback recently with the FDA's decision to slap a Class I status on the company's recall of its Zilver PTX stent, warning that the device's delivery catheter could lead to thrombosis, amputation or death. But the company has said it has identified the problem and tweaked its Zilver PTX manufacturing process accordingly. Zilver PTX has had some buzz around it because its December FDA approval made it the first drug-eluting stent in the U.S. cleared to treat peripheral artery disease.
Cook chairman Steve Ferguson, meanwhile, has become vocal opponents of the 2.3% medical device industry tax in the U.S., calling it a killer of jobs and innovation that is forcing device makers to move operations overseas.
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