While its traditional competitors are active in devices or capital equipment, Philips has set itself apart with its committed investment in health informatics, says CEO Frans van Houten, who wants to position the group as a leader in integrated care models.

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.

The agency sent a letter to health-care providers stating that it is investigating reports of an elevated risk of death for patients starting two years after treatment with paclitaxel-coated balloons or paclitaxel-eluting stents. But FDA is not taking any regulatory action at this point.