Latest From Terumo Corp.
Boston Scientific’s Synergy Stent Narrowly Outperforms Biosensors’ Biomatrix NeoFlex In Danish Study
Data from the 2,770-patient randomized SORT OUT VIII trial showed Boston Scientific’s Synergy everolimus-eluting stent is noninferior to Biosensor’s Biomatrix NeoFlex Biolimus-eluting stent for the endpoint of target lesion failure, but the procedure failure-rate was lower in the Synergy patients, which may have led to lower overall rates of myocardial infarction.
ACC Results Recap Part II: CardioMEMS Post-Approval Trial Shows Monitoring Reduces Heart-Failure Hospitalizations; Medtronic’s Tyrx Envelope Reduces Infections
Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the second of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including clinical trial data on devices from Abbott Laboratories, Medtronic, Medi-Lynx, and iRhythm. See Part 1 of our ACC Results Recap for more on the groundbreaking trials of transcatheter aortic valve replacement in low-risk patients and the Apple Heart study of Apple Watch's ability to track atrial fibrillation.
It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Terumo and Cook each nabbed US FDA approvals for endovascular devices.
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Shinjiro Sato, Pres. & CEO
Ryo Nishihata, Chief Accounting & Financial Officer
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