The FDA has issued a Class I recall for the Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent. All sizes, diameters and lot numbers manufactured prior to April 16 2013 are implicated.
Cook Medical’s aspirations with its Zilver® PTX® drug-eluting stent have been somewhat dented temporarily by the need to voluntarily recall the device following problems with its delivery device.
Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
The only FDA approved ureteral access sheath that has two options for placement is now available in the United States. The Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath allows urologists to use a single wire guide that functions as both a working wire and a safety wire.
Peripheral vascular disease treatments have shuffled under the spotlight in recent months with a seemingly endless trail of new devices and approvals for unblocking diseased vasculature. Now Cook Medical can say it has the first drug-eluting stent to be FDA approved for the job.
Cook Medical made the Zilver Vena™ Venous Self-Expanding Stent available to physicians across Canada at last week’s 2012 Annual Meeting of the Canadian Society for Vascular Surgery. Designed to restore blood flow in obstructed iliofemoral veins, Cook says the purpose-designed stent provides physicians with a tool designed specifically for the task.
Cook Medical has today announced a major development in the extension of its European operations with the opening of a new €15m distribution center in Baesweiler, Germany.
Cook Medical’s new Otolaryngology/Head and Neck Surgery clinical division is the company’s tenth business unit and is showing its new ideas to the specialty at this week’s AAO-HNS conference in Washington, D.C.
This is what targeted investment in a community looks like, as Cook Medical and its parent Cook Group adds a new manufacturing facility to Canton Illinois, having already built one two years ago… and a boutique hotel! Little wonder the company feels it has the moral high ground as it fights the Government’s new medtech tax plans.
Cook Medical’s Zilver® PTX paclitaxel-eluting peripheral vascular stent demonstrated 83.0 percent freedom from Target Lesion Revascularisation at 36 months in the PTX group, compared to 70.2 percent for patients treated with optimal percutaneous transluminal angioplasty and bare metal stents in the 479 patient study.
Cook Medical has announced general availability of the Aprima Access Nonvascular Introducer Set, the first product in the Aprima drainage portfolio. The system is purpose-designed for nonvascular single-puncture percutaneous access to facilitate placement of a working wire guide for interventional radiology procedures.
Cook Medical has gained 510(k) clearance for its Evolution® Colonic Controlled-Release Stent. The new stent is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures.
A new technique involving retrograde endovascular approach to occluded peripheral arteries shows promise, but hasn’t yet been formally studied. Cook Medical is supporting a multicentre effort to build an evidence base for what could be a promising solution to the major healthcare problems resulting from peripheral artery disease.
Cook’s range of fine needle biopsy histology needles is enhanced by the addition of this new 25gauge iteration, which, according to the company, is the smallest gauge endoscopy needle available today.
Let’s not argue about how to spell gauge by the way.
Foillowing its acquisition of General Biotechnology LLC, Cook Group has announced its formation of Cook General Biotechnology LLC, in a move which will help reinforce its position in the cellular therapy field.
Unrestrained euphoria as Cook Medical shows off its latest biopsy needles at interventional radiology meeting.