Novel system to protect against stroke via direct carotid access and robust blood flow reversal initiates a new era in carotid revascularization

SUNNYVALE, Calif., Feb. 10, 2015 /PRNewswire/ -- Silk Road Medical, Inc., a pioneer in the development of transcarotid therapies for intra and extracranial vascular diseases, announces the company has received Food & Drug Administration (FDA) 510(k) clearance for its ENROUTE Transcarotid Neuroprotection System (NPS).  The ENROUTE Transcarotid NPS is a first in class system used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while performing carotid angioplasty and stenting (CAS).


Read More: http://www.prnewswire.com/news-releases/silk-road-medical-announces-fda-510k-clearance-of-the-enroute-transcarotid-neuroprotection-system-300033527.html

Direct access stenting of the carotid artery shows promising results, especially for patients with difficult anatomy at high-risk for both surgery and transfemoral carotid artery stenting (CAS), according to data presented February 3, 2015, at the International Symposium on Endovascular Therapy in Hollywood, FL.

The Enroute transcarotid neuroprotection system (Silk Road Medical; Sunnyvale, CA) combines the concepts of blood flow reversal—via sheaths inserted in both the high-pressure common carotid artery and the low-pressure femoral vein, then connected through external tubing—and motorized external filter protection to bypass the aortic arch during CAS. The device holds CE Mark approval in Europe and is in the process of being evaluated by the FDA.

Read More: http://www.tctmd.com/show.aspx?id=127923

REDWOOD CITY, Calif., Feb. 4, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line advanced-stage non-small cell lung cancer (NSCLC).

Read More: http://www.virtual-strategy.com/2015/02/04/oncomed-initiates-dosing-phase-2-clinical-trial-demcizumab-treatment-non-small-cell-lung-#ixzz3TX7nGnlE