Q3 Global Device Approvals Shapshot: Another Big Quarter For Coronary And Peripheral Intervention Approvals
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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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 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.
As the pandemic unfolds with an uncertain outcome, US securities analysts that cover publicly traded medtech companies are developing mathematical models to estimate the impact of the COVID-19 pandemic on medtech companies.