Clinical Edge

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

FDA Approves Avalus Surgical Aortic Valve

Medtronic news release; 2017 Aug 2

The FDA has granted US approval and CE Mark for the Avalus surgical aortic valve for the treatment of aortic valve disease. The device is manufactured by Medtronic (Dublin, Ireland).

The Avalus valve is the only stented surgical aortic valve that is MRI-safe and is designed for excellent implantability. The device features several significant developments, including: a supra-annular design for excellent hemodynamic performance, intended to limit central regurgitation; interior-mounted leaflet and frame design to enhance durability; and a low-profile valve design, streamlined valve holder and a single, one-cut release to facilitate ease of implantation.

The FDA approval and CE Mark of the Avalus valve is based on subsets of data from the PERIGON Pivotal Trial, a single arm, non-randomized, prospective study of >1,100 patients from approximately 40 clinical sites across Europe, Canada and the US.

Citation:

Medtronic expands heart valve portfolio with FDA approval and CE Mark of the Avalus™ surgical aortic valve. [news release]. Dublin, Ireland: Medtronic; August 2, 2017: http://phoenix.corporate-ir.net/phoenix.zhtml?c=251324&p=irol-newsArticl.... Accessed August 3, 2017.

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