Cook Medical said on Saturday that it inked a deal to partner with Ambu A/S to distribute its single-use, disposable duodenoscope devices once they receive FDA clearance. Bloomington, Ind.-based Cook Medical said that Ambu is currently developing the scope to help address infections caused by cross-contamination, as reusable scopes pose a contamination risk and have […]
Cook Medical releases patient-level data from Zilver PTX paclitaxel-coated balloon study
Cook Medical said today that it is releasing de-identified patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes only a month after the FDA said that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease […]
First U.S. patient treated with Cook Medical endovascular aortic dissection system
Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., Cook Medical announced yesterday. The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of […]
Cook Regentec launches ProFusion therapeutic infusion needle
Cook Medical‘s Regentec division said today it launched the ProFusion therapeutic infusion needle designed for the intramuscular or subdermal infusion of therapeutic agents in the U.S. and Canada. The Indianapolis-based business said that the ProFusion Therapeutic Infusion Needle features multiple sideports arranged in a spiral to aid in the uniform delivery and dispersement of therapeutic […]
Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal
Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement. The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people treated with Cook […]
UPDATED: Cook Medical to pay $3m in damages in IVC bellwether
Updated to include a response from Cook Medical A federal jury in Indiana last week awarded $3 million in damages to a plaintiff in a bellwether case against Cook Medical over allegedly defective designs in the company’s Celect inferior vena cava filters. The plaintiff, Tonya Brand, sued Cook in 2014 alleging that the Celect IVC filter […]
Cook Medical wins FDA nod for Zenith aortic dissection repair stent
Cook Medical said today that it won FDA approval for its Zenith Dissection endovascular system intended to treat Type B aortic dissections. The Bloomington, Ind.-based company’s newly cleared system consists of a proximal stent-graft component and bare stent distal component and is intended to prove a less invasive alternative to open surgery for repairing Type B […]
IZI Medical picks up Cook Medical’s Quick-Core biopsy and breast localization needle assets
IZI Medical Products extended its M&A spree today with the acquisition of a set of biopsy and breast localization needles from Cook Medical for an undisclosed amount. Last September Chicago-based IZI picked up Benvenue Medical’s vertebral augmentation portfolio, also for an undisclosed amount; in May 2017, the company paid an unspecified price for Cook’s vertebroplasty devices, including the Duro-Ject […]
Cook Medical buys ex-cigarette plant in N.C.
Cook Medical said today that it inked a deal to buy a former cigarette manufacturing plant in North Carolina. The company plans to begin converting a portion of the R.J. Reynolds building in Winston-Salem’s Whitaker Park into a medical device manufacturing plant this year. More than 650 employees will work in the 850,000-square-foot facility, according […]
Judge guts plaintiff’s case in 2nd Cook Medical IVC bellwether
An Indiana judge last week gutted the plaintiff’s case in the second bellwether trial in the multi-district litigation brought over Cook Medical‘s inferior vena cava filters. Tonya Brand sued Cook in 2014, alleging that the Celect IVC filter implanted prior to a spine procedure fragmented, sending the broken pieces into her thigh and near her […]
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