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Gecko Biomedical receives CE Mark Approval for SETALUM ™ Sealant
Paris, France, September 11, 2017 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval for its SETALUM™ Sealant allowing the company to market its technology in Europe.The SETALUM ™ Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.The technology at the foundation of the SETALUM ™ Sealant...
Source: Medical Hemostat - October 25, 2017 Category: Medical Devices Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs

The FINISH-3 Trial: A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis
This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (spinal, hepatic, vascular, soft tissue dissection).
Source: Journal of the American College of Surgeons - October 13, 2014 Category: Surgery Authors: Grant V. Bochicchio, Navyash Gupta, Robert Porte, Kenneth L. Renkens, Piet Pattyn, Baki Topal, Roberto Ivan Troisi, William Muir, Ian Chetter, Daniel L. Gillen, Linda A. Zuckerman, Paul A. Frohna Tags: Original Scientific Article Source Type: research

A device to control bleeding in brain surgery receives Phase 2 SBIR grant
A medical device developer got a big boost in its efforts to develop a surgical sealant for brain surgery. Endomedix received a $1.49 million Phase 2 Small Business Innovation Research grant to help control bleeding for surgical procedures, according to a company statement. It received the grant from the National Institute of Neurological Disorders and Stroke.The funding will go toward safety studies, in vivo performance studies and developing an applicator device. The sealant is a hydrogel that includes two processed biocompatible polysaccharides. They are simultaneously mixed and sprayed onto a surgical site.Typically, a...
Source: Medical Hemostat - June 3, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs

FDA Accepts Biomedica MC Investigational New Drug Filing for ClotFoam®
The U.S. Food and Drug Administration (FDA) has accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company is developing ClotFoam as the leading agent of a portfolio of hemostatic products based on its proprietary “CLOT” technology. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health.ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicin...
Source: Medical Hemostat - September 9, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs

A Prospective, Randomized, Controlled Trial of the Efficacy and Safety of Fibrin Pad as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
This study evaluated the hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities.Study Design: Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable hemostat (NCT00658723). Patients were stratified by bleeding severity at the TB...
Source: Journal of the American College of Surgeons - September 1, 2013 Category: Surgery Authors: Craig P. Fischer, Grant Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James C. Hart Tags: Original Scientific Articles Source Type: research