Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]
Cook Medical relaunches Beacon Tip catheters in Europe
Cook Medical said today that has relaunched its Beacon Tip catheters in Europe, three years after withdrawing them from the market worldwide. The catheters are now available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook said it is working on relaunching […]
Dynatronics promotes COO Baker to replace von Jako as CEO | Personnel Moves, August 30, 2019
After deciding this week that its CEO needs to be based in Eagan, Minn., and with chief executive Chris von Jako unwilling to relocate his family, Dynatronics (NSDQ:DYNT) promoted COO Brian Baker to the corner office, effective August 28. “After thoughtful consideration, the board of directors determined that the company’s CEO needs to be based in […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Cook Medical recalls peripheral catheters on burst balloon risk
Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Cook Medical partners with Ambu A/S to distro single-use duodenoscope pending FDA approval
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 […]
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