Abiomed Submits 510(k) For Impella Ventricular Assist Device
This article was originally published in The Gray Sheet
Executive Summary
Abiomed hopes to gain FDA market clearance of its Impella 2.5 minimally invasive ventricular assist device later this year following the firm's recent 510(k) submission, announced Feb. 5
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Abiomed Markets Impella 2.5 Cardiac Assist Device To Cath Labs
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Northstar names CEO: Chief Operating Officer John Bowers assumes the top spot at Northstar Neuroscience June 29. Prior to joining Northstar in 2004, Bowers served 10 years at Guidant in marketing, business development and sales management, for a time leading the marketing and business development efforts for the company's drug-eluting stent business now owned by Abbott. He replaces Alan Levy, who will become chairman of the board. The firm is on track to submit a PMA by early next year for its cortical stimulation device for hand and arm rehabilitation in stroke victims. Clinical trials are ongoing for the device's use in treating stroke-related aphasia, tinnitus and treatment-resistant depression (1"The Gray Sheet" Oct. 9, 2006, In Brief). On April 26, Northstar reported a net loss of $4.3 million for the first quarter of 2007...