FierceBiotech

Cook wins 510(k) status for next-gen biliary stent

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 ...
TCTMD

‘Inadvertent Reversal’ of Late Mortality Data Flips Advantage From Paclitaxel Zilver PTX Stent in PAD to PTA

(UPDATED) A serious error in data reporting in the Zilver PTX trial reverses the conclusion that there was a long-term mortality advantage for the paclitaxel-based ...
FierceBiotech

Cook moves past April recall with stellar 4-year data for Zilver stent

Cook Medical is touting stellar four-year patient data for its signature Zilver PTX drug-eluting stent, six months after launching a global recall because some of the devices broke from their delivery ...
News Medical

FDA approves new 5 mm diameter drug-eluting stent from Cook Medical

Cook Medical announced that a new 5 mm diameter version of Zilver ® PTX ® was approved by the FDA. It is the first 5 mm drug-eluting stent in the U.S. with lengths available up to 140 mm that is ...