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Cook Group Inc.

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Latest From Cook Group Inc.

FDA Finalizes Peripheral Vascular Atherectomy Guidance

The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.

Regulation Medical Device

Veteran Political Operative Joins AdvaMed To Lobby Dems

A former Democratic congressional staffer has joined the medtech industry lobby group to shepherd efforts including the medical device tax repeal, upcoming device user-fee negotiations, and more.

Regulation Lobbying

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Safety Research & Development

2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott

Reported sales and earnings from the publicly traded cardiovascular device companies in 2018 were generally strong, led by transcatheter aortic valve replacement devices, but some sectors of the industry, especially ventricular assist devices and peripheral drug-coated balloons, face significant challenges. Here's a recap of results from the cardio device companies that have reported so far, with a focus on Medtronic, Edwards, and Abbott.

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