Orchestra BioMed Inc. has secured Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its Virtue Sirolimus-Eluting Balloon for the treatment of coronary in-stent restenosis (ISR).

Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System
This is an angiographic view of a deployed transcatheter Lotus aortic valve.

Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) approval for the Lotus Edge Aortic Valve System. Delivered via a minimally invasive procedure, this transcatheter aortic valve replacement (TAVR) technology is approved for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.

Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may help predict who will be readmitted to the hospital within a month, according to new research in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

April 22, 2019 — Five cardiovascular professional societies released a new consensus document on optimizing care for patients with valvular heart disease.

The Medicare Hospital Insurance (HI) Trust Fund, which funds Medicare Part A, will only be able to pay full benefits for Medicare beneficiaries until 2026, according to the 2019 annual report from the Medicare Board of Trustees. The Supplementary Medical Insurance (SMI) Trust Fund, which funds Medicare Part B and D, is expected to be adequately financed in all years, but the aging population and rising healthcare costs are projected to grow SMI costs from 2.1 percent of gross domestic product (GDP) in 2018 to approximately 3.7 percent of GDP in 2038.

SCAI SHOCK: Treating the Spectrum of Cardiogenic Shock

SCAI SHOCK: Treating the Spectrum of Cardiogenic Shock aims to provide a comprehensive review of the definition, diagnosis, and management of cardiogenic shock across the spectrum of care, including different etiologies of shock and various presentation settings from the emergency room to cath lab, community hospital to a large academic center. An overview of shock initiatives, the spectrum of shock, and systems of care will be provided.

New guidelines that classified more children as having elevated blood pressure  are better at predicting which kids are likely to develop heart disease when they reach adulthood, according to new research in the American Heart Association’s journal Hypertension. The guidelines were issued by the American Academy of Pediatrics (AAP) in 2017 and endorsed by the American Heart Association.

Aziyo Biologics Inc. announced the publication of results from its landmark RECON study in the Journal of Cardiothoracic Surgery1. The prospective, single-arm study included 1,420 patients in 42 hospitals across the United States and represents the largest pericardial-closure study conducted to date. The goal of the study was to evaluate clinical outcomes with pericardial reconstruction using ProxiCor, the company’s proprietary decellularized extracellular matrix (ECM) scaffold designed for the repair of the pericardium.

The U.S. Department of Health and Human Services (HHS) is extending the public comment period by 30 days for two proposed regulations aimed at promoting the interoperability of health information technology (health IT) and enabling patients to electronically access their health information. The new deadline for the submission of comments – June 3, 2019 – will allow additional time for the public to review the proposed regulations.

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