Starts & Stops: Abbott, Medtronic Announce Major Trial Activities
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This edition includes entries from a variety of companies and technologies, including many post-market studies following regulatory approvals.
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FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.
Medtech firms entered 2018 knowing that demands from providers and payers are increasing, the pace of business is quickening, and at the same time patients are more empowered and market access routes are more exacting than ever. Against this backdrop, PwC explains the top health industry issues for the coming year, highlights the forces that will have the most impact on the industry in 2018 and explains why manufacturers need to be nimble.
Abbott Laboratories' Freestyle Libre Flash is the first continuous glucose monitoring system to gain US FDA approval that lets diabetics avoid the additional step of fingerstick calibration to measure their glucose levels, "with the wave of a mobile reader," the agency says.