Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the New Drug Application (NDA) for its investigational, oral, once-daily direct factor Xa-inhibitor SAVAYSATM (edoxaban) Tablets has been submitted to the U.S. Food and Drug Administration (FDA). In the U.S., Daiichi Sankyo is seeking approval for edoxaban for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE). SAVAYSA is the proposed brand name for edoxaban if approved for marketing in the U.S.

The Icahn School of Medicine at Mount Sinai joins a top-flight network of 25 regional stroke centers announced by the National Institute of Health that will focus on prevention, treatment, and recovery from stroke. As part of the NIH Stroke Trials Network (NIHStrokeNet), the medical school will receive a 5-year, $1.3 million grant to build a collaborative research infrastructure for a regional coordinating stroke center.

The University of Texas Health Science Center at Houston (UTHealth) has been named one of 25 regional stroke centers by the National Institutes of Health (NIH) and the only one in Texas.

Medtronic, Inc. (NYSE: MDT), announced today CE Mark (Conformité Européenne) in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its highly flexible 4 Fr multi-electrode Symplicity Spyral™ catheter and Symplicity G3™ radio frequency (RF) generator. 

Chosen for nearly one out of every two endovascular abdominal aortic aneurysm (AAA) repairs worldwide, the Endurant II AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to demonstrate long-term durability and consistent outcomes at three years in a real-world setting.

The first device of its kind to undergo clinical evaluation in the United States, the Valiant "Mona LSA" branch thoracic stent graft system from Medtronic, Inc. (NYSE: MDT) has demonstrated proof of concept in a first-in-human study being conducted under the U.S. Food and Drug Administration (FDA)'s "Innovation Pathway" early feasibility pilot program, according to data presented today at the 2013 VEITHsymposium(tm).

A new network dedicated to advancing research and therapies for stroke is forming in Chicago thanks to $2 million in grants from the National Institutes of Health (NIH). The Chicago Stroke Trials Consortium is a partnership among Northwestern Medicine®, Ann & Robert H. Lurie Children's Hospital of Chicago, John H. Stroger Jr. Hospital of Cook County, Loyola University Medical Center, Rehabilitation Institute of Chicago, Rush University Medical Center, and University of Chicago Medicine that will build an infrastructure to support clinical trials for stroke prevention, treatment and recovery. Northwestern University will be the regional coordinating center for the consortium and administer the project over the next five years.

The American Heart Association today awarded its Clinical Research Prize for 2013 to Thomas Brott, M.D., “for his leadership of significant and innovative clinical research validating new procedures that have enhanced care of patients suffering stroke and helped to minimize or overcome its damaging effects.”