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.
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Abiomed is trying to counter the negative publicity created by the recent publication of retrospective studies showing higher costs and worse outcomes in coronary intervention cases with Impella than in comparable procedures with intra-aortic balloon pumps. The company insists this analysis is deeply flawed.
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.
Earnings Winners & Losers: ABMD, BSX, EW, ABT Pump Money Into Cardio; SYK, ZBH Innovate Ortho Surgery
Most of the major medical device companies have reported sales and earnings for the last three months of 2017 and the full year. Cardiovascular companies are succeeding with new technology while continuing to grow revenues from established technologies, especially in emerging markets. Orthopedic firms are looking to new technology, like surgery robots and neurostimulation, to differentiate themselves from the competition and improve profits.