September 28, 2012 — MindChild Medical Inc. announced that it has received 510(k) premarketing notification clearance from the U.S. Food and Drug Administration (FDA) for its Meridian noninvasive fetal heart monitor, and anticipates entering the U.S. market with Meridian soon. Additional pre-market regulatory filings are anticipated during 2012 and 2013.

September 28, 2012 — Accumetrics Inc., developer of the VerifyNow System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced the launch of its Quality Improvement and Value Assessment Program.

Abbott Bioabsorbable Stent Absorb

The world’s first drug-eluting bioabsorbable vascular scaffold has been launched and will revolutionize the stent industry. On Sept. 25, 2012, Abbott announced the launch of its drug-eluting bioabsorbable stent, Absorb, in Europe, the Middle East and parts of Asia Pacific and Latin America. Absorb, which received CE mark certification in 2011, is used to treat coronary artery disease. Bioabsorbable stents, such as Absorb, will broaden treatment and diagnostic options, reduce the need for long-term anti-platelet therapy and reduce the risk of in-stent restenosis and thrombosis.

September 28, 2012 — Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) clearance for the Emerge percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter, and has begun marketing the device in the United States.

Medtronic Inc. announced it has received CE mark for its Medtronic CoreValve Evolut 23 mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system.

Boston Scientific has launched the Promus Element Plus BTK (Below The Knee) everolimus-eluting stent system in European countries for the treatment of certain severe peripheral artery lesions. The drug-eluting stent (DES) has CE mark approval for both monorail and over-the-wire (OTW) versions and will be available immediately.

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