Category: Cook Medical
Cook Medical pulls its newly FDA-approved Zilver PTX drug-eluting stent from the shelves after receiving reports of 1 patient death and 1 injury possibly associated with breakage in the catheter delivery system.
Updated April 25, 2013 with additional comments from Cook Medical.
Cook Medical recalled all sizes, diameters and lot numbers of its Zilver PTX drug-eluting stents after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. It's not clear when the devices will be back on the market, according to a company spokesman.
Cook Medical launches a clinical study of its Zilver Vena stent, the 1st trial of its kind in the U.S. assessing an iliofemoral venous self-expanding stent.
Indiana medical device giant Cook Medical announced the launch of a new clinical study, the 1st of its kind evaluating the safety and effectiveness of its Zilver Vena venous self-expanding stent.
The VIVO study will enroll select adult patients experiencing limiting leg pain, leg swelling or skin discoloration or a healed or active lower leg ulcer, according to a Cook statement.
Cook Group chairman Steve Ferguson told Sen. Pat Toomey (R-Pa.) at a House Ways & Means Committee meeting yesterday that the medical device tax is the "straw that broke the camel's back" in terms of sending medical device manufacturing overseas.
A "smart" prosthetic foot and ankle system uses microprocessor technology and a smartphone app that allows the device to adjust to a user's needs by responding to the environment or taking orders directly from the patient.
MASSDEVICE ON CALL —
Hospital group purchasing organization Novation awards new contracts for cardiovascular products to a clutch of market leaders.
Group purchasing organization Novation awarded new cardiovascular contracts to a host of market leaders, effective at the beginning of 2013.
Endotach LLC sues Medtronic, alleging infringement of a pair of patents covering stent graft technology by the medical device company's Talent, Valiant and Endurant devices.
Medtronic (NYSE:MDT) infringes a pair of patents licensed to Endotach LLC with 3 of its stent grafts for treating abdominal aortic aneurysms, according to a lawsuit filed by Endotach against the medtech titan.
The Frisco, Texas-based company holds the exclusive license to the duo of patents from their inventor's widow, according to court documents.
The FDA awards premarket approval to Cook Medical for its Zilver PTX stent, the 1st U.S. market-approved drug-eluting stent indicated for treatment of peripheral artery disease.
Cook Medical finally own premarket approval for its Zilver PTX stent, making it the 1st drug-eluting stent approved by the FDA for treatment of peripheral artery disease.
The approval comes 1 year after the FDA's Circulatory Systems Devices Panel unanimously recommended approval for the device, which is a self-expanding drug-eluting stent coated in paclitaxel.