FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood […]
Cook Medical
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. […]
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
Cook Medical has a serious catheter recall
FDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). […]
Cook Medical launches global catheter introducer recall
Cook Medical has launched a voluntary recall of nearly 59,000 devices intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The Flexor Check-Flo introducer and Flexor Tuohy-Borst side-arm introducer (Shuttle Select) are sterile, single-use devices that incorporate a hydrophilic-coated shaft in varying stiffnesses with distal radiopaque markers. The recall covers […]
Cook Medical announces U.S. launch of balloon for transnasal esophageal procedures
Cook Medical today commercially launched its Hercules 100 Transnasal Esophageal Balloon in the U.S. The balloon is designed specifically for trans nasal esophageal procedures and is another tool for ENT physicians to help treat esophageal strictures. “This balloon was specifically designed with ENT physicians and their patients in mind. The balloon is much shorter than […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
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 […]
