Boston Scientific reported favorable six-month results from the first 60 patients enrolled in the REPRISE II clinical trial evaluating the safety and performance of the Lotus Valve System in symptomatic patients with severe aortic stenosis considered at high risk for surgical valve replacement.

JenaValve Technology Inc. has received CE (Conformite Europeenne) mark approval from European regulators for its transapical TAVI system for the treatment of aortic insufficiency (AI), also known as aortic regurgitation, in which the native aortic valve does not close properly and allows blood to leak back into the left ventricle of the heart.

Decision Resources forecasts that Bayer/Janssen's Xarelto will be the sales-leading therapy among the novel oral anticoagulants in the combined venous thromboembolism (VTE) markets. Xarelto benefits from its first-to-market advantage for VTE treatment/secondary prophylaxis, the removal of the need for bridging with a low-molecular-weight heparin in the VTE treatment/secondary prophylaxis setting and once-daily dosing. Bristol-Myers Squibb/Pfizer's Eliquis will be Xarelto's closest competitor, but its later launch in both the VTE primary prophylaxis and VTE treatment/secondary prophylaxis markets, as well as its twice-daily dosing, will likely limit its sales relative to Xarelto during the 2012 to 2022 forecast period.

Simbionix USA Corp. released the Endovascular Basic Skills training module for the ANGIO Mentor simulator. The Simbionix ANGIO Mentor is a virtual-reality training simulator that provides hands-on practice in a simulated environment for endovascular procedures. An expanding library of modules supports the acquisition and honing of procedural skills to build confidence and proficiency in various endovascular techniques and procedures.

In a significant milestone toward obtaining additional key regulatory approvals for the Synergy drug eluting stent system, Boston Scientific Corp. has completed enrollment in the EVOLVE II randomized, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy stent system and support U.S. Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  The Synergy stent uses the market-leading everolimus drug and features an ultra-thin directional polymer coating that is absorbed by the body shortly after drug elution ends at three months.

The new VitalView software from SunTech Medical provides physicians with a data management tool to help efficiently diagnose and treat patients. The new software works with the company’s non-invasive spot check device to reduce the risk for errors in clinical workflows.

Subscribe Now