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Q3 Global Device Approvals Shapshot: Another Big Quarter For Coronary And Peripheral Intervention Approvals

Executive Summary

The third quarter of 2018 brought 60 approvals from outside the US, including 31 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, six were for devices to treat coronary artery disease; the second most common indications were peripheral disease and catheter complications. Outside of Europe, India recorded the most non-US approvals in the quarter with eight.

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Global Device Approvals Q2 Shapshot: Coronary Devices Abound

The second quarter of 2018 brought 62 approvals from outside the US, including 46 in Europe, according to Medtech Insight's Approvals Tracker. Among those approvals, 14 were for devices to treat coronary artery disease, and the second most-common indications were obesity and soft-tissue repair. Outside of Europe, Japan had the most non-US approvals in the quarter with five.

FDA Lowers Barrier To Market Penetration For Abiomed's Impella With Expanded Indication

FDA has removed "depressed ejection fraction" from the approved indication for Abiomed's Impella 2.5 and Impella CP based on results from the cVAD registry. The registry data support expanding the FDA-approved indication for the heart pumps during elective and urgent high-risk percutaneous coronary interventions, as well as for patients with cardiomyopathy leading to cardiogenic shock.

News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More

Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.

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