Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Recapturable TAVR System

Medtronic news release; 2016 Oct 26

The FDA has granted the US approval of the CoreValue Evolut R 34 mm valve (Medtronic plc, Dublin, Ireland), the largest size transcatheter aortic valve replacement (TAVR) system available in the US.

Indication: The Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.

Administration: The Evolut R 34 mm valve is delivered through the En Veo R Delivery Catheter System, which features an InLine Sheath. The Evolut R System is designed to fit within the native aortic valve, using its supra-annular valve positions to help achieve hemodynamic performance.

Citation:

Medtronic announces FDA approval of new recaptureable TAVR system available for severe aortic stenosis patients with large anatomies. [news release]. Dublin, Ireland: Medtronic plc; October 26, 2016: http://phoenix.corporate-ir.net/phoenix.zhtml?c=251324&p=irol-newsArticl.... Accessed November 1, 2016.

This Week's Must Reads

Detection & Management of Resistant Hypertension, Hypertension; ePub 2018 Sep 13; Carey, et al

Does Aspirin Prevent CV Events in Older Adults?, N Engl J Med; ePub 2018 Sep 16; McNeil, et al

Timing of ICD Placement From Last Hospitalization for HF, Circulation; ePub 2018 Sep 13; Ambrosy, et al

FFR and Quality of Life After PCI, Circulation; ePub 2018 Sep 18; Nishi, et al

VTE risk for continuous cycle oral contraceptives, Li J et al. JAMA Intern Med. 2018 Oct 1. doi:10.1001/jamainternmed.2018.4251

Must Reads in FDA Actions

FDA Approves Giapreza for Treatment of Low BP, FDA news release; ePub 2017 Dec 21

FDA Approves EKG Device for Apple Watch, AliveCor news release; 2017 Nov 30

FDA Approves Expanded Indication for Tekturna, Noden Pharma news release; 2017 Nov 14

FDA Approves Xarelto for Extended Treatment of VTE, Bayer news release; ePub 2017 Oct 30

HeartWare HVAD System OK’d for Destination Therapy, Medtronic news release; 2017 Sep 27