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 […]
Cook Medical inks deal to distribute Taewoong Medical Niti-S esophageal stents
Cook Medical said today that it inked a collaborative deal with South Korean Taewoong Medical to distribute a selection of the company’s stents in the U.S. The deal includes Taewoong’s Niti-S Through The Scope esophageal stent, which is the flagship product of the company’s Niti-S self-expandable line of metal gastrointestinal stents, Cook said. The Niti-S TTS […]
Cook Medical wins FDA nod for 5mm Zilver PTX stent
Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. Get the full story at our […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. Get the full story at our […]
FDA closes out Cook Medical manufacturing facility warning letter
Cook Medical said today that the FDA closed out a 2014 warning letter it sent to the company over quality system issues with its Bloomington, Ind.-based manufacturing facilities. The company touted the closure of the warning letter for the plant, which makes vascular implants, intravascular catheters and related systems, and said that it was the result […]
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