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.

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.

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.

The Society for Cardiovascular Angiography and Interventions’ Vascular Disease Council says the recent meta-analysis finding a higher long-term mortality risk with paclitaxel-eluting peripheral devices can only be viewed as hypothesis-generating. The long-term risks of these devices should be investigated with patient-level data, SCAI argues. Several clinical data presentations at the recent LINC meeting in Leipzig showed comparable mortality rates with paclitaxel-eluting devices as comparable non-drug-eluting devices.