UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
Cook Medical issues Class I recall of CrossCath Support Catheters
Cook Medical is recalling its CrossCath Support catheters due to potential marker bands dislodging or buckling in a Class I recall. Cook Medical said an error occurred during manufacturing that could cause radiopaque marker bands to be too loose on some CXC3.0 CrossCath Support Catheters and could be too tight on certain CXC3.4 CrossCath Support […]
Study: Stents no better than drugs for stable heart disease
This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]
Cook Medical India opens new facility in Chennai
Cook Medical India has opened a new office facility at Kochar Jade in Guindy, Chennai, in the city’s major business district. The modern, 20,000-square foot office is slated to host training facilities with up-to-date video conferencing equipment and presentation aids that support collaborative learning, the company said in a news release yesterday. The location is also […]
New FDA guidance out for vascular device labels
The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires. Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and […]
Cook Medical touts paclitaxel-coated stent PAD study results
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 […]
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