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.
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
Relevance of Health Literacy to CV Health, Circulation; ePub 2018 Jun 4; Magnani, et al
Can Biomarkers Predict Causes of Death in AF?, Circulation; ePub 2018 Jun 5; Sharma, et al
Aspirin Benefit in Adverse Pregnancy Outcomes, Hypertension; ePub 2018 May 25; Hauspurg, et al
Care for IHD and CHF Varies in VA Health System, JAMA Cardiol; ePub 2018 May 16; Groeneveld, et al
Comparing Hypertension Guidelines in CV Events, JAMA Cardiol; ePub 2018 May 23; Bundy, et al
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