Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee.
Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI).
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Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter.
Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions that could lead to permanent impairment or death, according to the company.
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Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters.
Bloomington, Indiana-based Cook Medical field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo proximal fitting instead of the distal tip.
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Cook Medical announced that the Litho 150 laser from Quanta is now available in the U.S. through its distribution channels.
Bloomington, Ind.-based Cook Medical said in a news release that the Litho 150 is the most recent product in Quanta’s line of laser systems and it complements Cook’s line of urologic stone management disposables. The system has indications for use in a variety of endoscopic and urological surgeries, including benign prostatic hyperplasia procedures and urological stone management.
Litho 150 also consists of an advanced cooling system that makes the machine run quietly, along with a Virtual Basket pulse modulation feature that allows for fine lithotripsy and minimal stone movement without the need for expensive additional fibers, Cook Medical said.
Additionally, Litho 150 includes the Vapor Tunnel low-energy pulse feature designed to create a vapor bubble between the laser tip and stone to allow for a more powerful pulse …
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 leakage called Type III endoleaks. Endologix has found itself having to vigorously defend itself against studies claiming a problem.
The FDA is presently advising that anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) visits a doctor at least once a year to get checked for leaks.
Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place follo…
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. Cook plans to seek an investigational device exemption approval in the coming months, with a pivotal clinical study starting later this year.
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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 in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.
Here are the nine most serious catheter-based device recalls of 2020.
Next >>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 late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.
Labeling changes will apply to instructions for use of these devices throughout Europe and will include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…