News Briefs: Approvals For Abbott’s MitraClip, Allergan’s Juvéderm; Diagnostics News
This article was originally published in The Gray Sheet
FDA approved Abbott’s MitraClip to treat mitral regurgitation and Allergan’s Juvéderm Voluma XC facial filler to temporary correct volume-loss. Hepatitis C testing will be mandatory in New York. More news.
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The US heart valve treatments market will reach $1.7 billion by 2019, driven by advances in percutaneous heart valve repair and replacement products and a growing number of competitors entering this space. With US sales of transcatheter aortic valve replacement systems set to almost triple in the next several years, the combined US market for products to treat heart valve disorders is expected to grow at a CAGR of 7.7%.
CMS finalized a decision to cover screening for the Hepatitis C virus under Medicare for all adults born between 1945 and 1965, and all “high risk” adults.
A new draft national Medicare coverage policy offers to pay for transcatheter mitral valve repair procedures with devices like Abbott’s MitraClip only if they are conducted by a qualified heart team and are part of a national registry.