Firm gains CE mark approval of its EndoBarrier gastrointestinal liner device to treat obesity and type 2 diabetes. A sham-controlled pilot trial presented at the First World Congress on Interventional Therapies for Type 2 Diabetes in New York in September showed that EndoBarrier reduces average blood glucose levels in patients with type 2 diabetes (1"The Gray Sheet" Oct. 6, 2008, p. 22). Another recently published study shows EndoBarrier imitates the treatment effect of Roux-en-Y bypass surgery, including weight loss and improved metabolic function in rats with diet-induced obesity (2"The Gray Sheet" Nov. 24, 2008, p. 16). The company is planning to conduct larger, long-term trials in 2009
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.
Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.