MicroMed DeBakey Heart-Assist Device Pivotal Trial Gets IDE Clearance
This article was originally published in The Gray Sheet
Executive Summary
The pivotal study for MicroMed's DeBakey left-ventricular assist device will be led by Columbia University's Eric Rose, MD, the researcher who helped secure the first FDA approval and Medicare reimbursement of permanent LVADs
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Medtronic diabetes care update: Firm will initiate full market release of its Guardian continuous glucose monitoring system, PMA-approved in January, into the $3 bil. blood glucose monitoring market by February 2005, CFO Bob Ryan notes Dec. 1 at the Lazard Life Sciences Conference in New York. In FY 2006, Medtronic plans to launch the next-generation Guardian RT, capable of displaying a patient's "real time" glucose value in five-minute intervals, he added. The company expects to integrate Guardian RT with its Paradigm sensor-augmented insulin pump technology, as part of the effort to develop a closed-loop, external artificial pancreas for diabetic patients by 2008 (1"The Gray Sheet" June 21, 2004, p. 26). Ryan also reported Medtronic is conducting a clinical trial to drive insulin pump therapy penetration. The study will compare insulin pumps with multiple daily injections. The exec believes that a device capable of dropping the HbA1c levels in Type 1 diabetic patients to 7% could lower diabetes healthcare costs by $100 bil. over the next 10 years...
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Medtronic diabetes care update: Firm will initiate full market release of its Guardian continuous glucose monitoring system, PMA-approved in January, into the $3 bil. blood glucose monitoring market by February 2005, CFO Bob Ryan notes Dec. 1 at the Lazard Life Sciences Conference in New York. In FY 2006, Medtronic plans to launch the next-generation Guardian RT, capable of displaying a patient's "real time" glucose value in five-minute intervals, he added. The company expects to integrate Guardian RT with its Paradigm sensor-augmented insulin pump technology, as part of the effort to develop a closed-loop, external artificial pancreas for diabetic patients by 2008 (1"The Gray Sheet" June 21, 2004, p. 26). Ryan also reported Medtronic is conducting a clinical trial to drive insulin pump therapy penetration. The study will compare insulin pumps with multiple daily injections. The exec believes that a device capable of dropping the HbA1c levels in Type 1 diabetic patients to 7% could lower diabetes healthcare costs by $100 bil. over the next 10 years...
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