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Total 442 results found since Jan 2013.
Baxter Introduces Hemostat in Europe
DEERFIELD, Ill., Oct 23, 2013 (BUSINESS WIRE) -- Baxter International Inc. BAX -0.04% today announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter's expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.''HEMOPATCH is a valuable addition to the tools in the surgica...
Source: Medical Hemostat - October 28, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
BioCer Present Newly EU Approved Super Rapid Plant-based Hemostat at EACTS
BAYREUTH, Germany, September 24, 2013 /PRNewswire via COMTEX/ -- BioCer Entwicklungs GmbH (BCE) a German implantable biological medical device development and manufacturing company announced today that it has achieved commercial approval to begin distribution in the EU, and international markets where CE mark is accepted of HaemoCer Plus. HaemoCer Plus is an Absorbable Polysaccharide Hemostat (APH) and an innovative powerful hemostatic technology that exhibits exceptional speed and ratio of absorbency."HaemoCer Plus follows 2 years of development and is a huge technological milestone with clear efficiency benefits. In comp...
Source: Medical Hemostat - September 24, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Hemostasis and Tissue Sealing Agents Market to Experience Significant Growth Due to Aggressive Marketing Strategies
The global hemostasis and tissue sealing agents market signifies the market for sophisticated hemostat medical devices. These devices are utilized to control excessive bleeding in operations and surgeries and have significant roles in assisting healing processes in surgical procedures. Introduction of New Products Driving Hemostasis and Tissue Sealing Agents MarketThe hemostasis and tissue sealing agents market is going through a steady growth phase. The major companies in the hemostasis and tissue sealing agents industry are adopting aggressive marketing strategies to increase their product penetration rate in the ma...
Source: Medical Hemostat - August 24, 2015 Category: Medical Equipment Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
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SAN JOSE, Calif.--(BUSINESS WIRE)--Starch Medical Inc. a privately held manufacturer and marketer of polysaccharide based hemostatic products for use in controlling bleeding in surgery and trauma applications has expanded its product portfolio with the launch of SuperClot ® Hemostat in Europe.Starch Medical received CE Approval earlier this year for SuperClot ® and will utilize their existing network of distribution partners along with new strategic partners to bring this innovative new polymer hemostat solution to surgical teams and hospitals throughout Europe. Next week Starch Medical will exhibit and hold distributor ...
Source: Medical Hemostat - November 8, 2017 Category: Medical Devices Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
US FDA clears Abyrx's absorbable haemostatic bone putty for clinical use
Abyrx, Inc., a privately-held therapeutic device company, has received the United States Food and Drug Administration (FDA) clearance for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the state.AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to...
Source: Medical Hemostat - July 2, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
MDCO, Bristol-Myers Squibb begin global alliance for Recothrom
The global license and two-year collaboration signed between the Medicines Company (MDCO) and Bristol-Myers Squibb (BMS) for Recothrom, a recombinant thrombin approved by the US Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures has become effective.The agreement was first announced in December 2012. The companies have satisfied all required regulatory and closing conditions.Glenn Sblendorio, president and chief financial officer of The Medicines Company, said, "We look forward to the start of our global license and collaboration for Recothrom. We be...
Source: Medical Hemostat - February 13, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Medafor sells to Bard for $200 million, plus incentives that could add another $80 million.
Officials at Medafor Inc., a Brooklyn Center-based maker of a novel blood clotting product, said they’ve been looking for ways to enhance shareholder value — be it an initial public offering, new business relationships or just continuing organic growth. The one thing they weren’t looking for was a buyer, leaders said Monday.Then the folks at C.R. Bard Inc., a New Jersey-based medical equipment maker, came calling.Their offer — $200 million in cash now and up to $80 million more if revenue targets are hit in the next two years — proved too attractive to pass up, said Medafor CEO Gary Shope.Medafor on Monday announ...
Source: Medical Hemostat - August 20, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Johnson & Johnson (JNJ) Announces Additional FDA Indication for EVARREST Fibrin Sealant Patch
Johnson & Johnson (NYSE: JNJ) announced the following Monday:Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients.A problematic bleeding situation—involving bl...
Source: Medical Hemostat - April 5, 2015 Category: Medical Equipment Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Johnson & Johnson (JNJ) Announces Additional FDA Indication for EVARREST Fibrin Sealant Patch
Johnson & amp; Johnson (NYSE: JNJ) announced the following Monday: Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon ' s EVARREST Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients. A problematic bleeding situation —...
Source: Medical Hemostat - April 5, 2015 Category: Medical Equipment Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Baxter acquires surgical products
Baxter International Inc., a global medical products company, said Monday that it will acquire two hemostat and sealant products from Mallinckrodt.It will acquire Recothrom Thrombin topical, the first and only stand-alone recombinant thrombin, and Preveleak Surgical Sealant, which is used in vascular reconstruction." Uncontrolled intraoperative bleeding can lead to a wide variety of clinical and economic complications for patients and hospitals. As a leading provider of advanced hemostats and sealants, Deerfield-based Baxter is focused on continually identifying solutions to help meet surgeons ' varying needs, " said Wil B...
Source: Medical Hemostat - January 9, 2018 Category: Medical Devices Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
ProFibrix Phase III Trial with FibrocapsTM (FINISH-3) Passes Important Safety Milestone & Almost Completes Enrolment
LEIDEN, The Netherlands & SEATTLE -- ProFibrix B.V., the leader in next generation hemostatics, today announced that the Data Monitoring Committee (DMC) of the FINISH-3 trial of Fibrocaps unanimously recommended the study to continue as designed. The DMC is an independent expert panel overseeing patient safety of this pivotal trial in spine, liver, vascular and soft tissue surgery. At its final meeting, the DMC reviewed data from the first 403 subjects enrolled in the trial, and found no safety concerns.To date, less than 9 months after the first subject was enrolled, over 85% of the 672 subjects necessary to comp...
Source: Medical Hemostat - February 13, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
ProFibrix Completes Patient Enrolment in Pivotal Phase III with FibrocapsTM and Reports Positive Feedback from Surgical Community
Company remains on track for 2013 filings in US and EuropeLEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced that the company has completed enrolment of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) on schedule.FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in surgical patients with mild to moderate surgical bleeding. Participating surgeons enrolled a total of 718 patients in only 10 months. The main objectives of the study are to de...
Source: Medical Hemostat - April 4, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
RECOTHROM Becomes the First and Only Topical Thrombin Indicated for Use in Children Greater Than or Equal to One Month of Age
This study was conducted in 30 pediatric patients greater than one month of age undergoing synchronous burn wound excision and skin grafting. The safety of RECOTHROM in pediatric patients greater than or equal to one month of age is supported by these data and by extrapolation of efficacy from adequate and well-controlled studies of RECOTHROM in adults. Safety and efficacy has not been established in neonates."Our purpose is to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world," said Brent Furse, Senior Vice President and Chief Customer Office...
Source: Medical Hemostat - May 12, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs
Military, civilian medical experts emphasize investment in acute trauma care
FORT LAUDERDALE, Fla. (Aug. 13, 2013) -- From battlefield blasts to plane crashes, major advancements in acute trauma care are being seen in both the military and civilian health sectors, agreed experts during roundtable discussion at the 2013 Military Health System Research Symposium, Aug. 13, in Fort Lauderdale, Fla. Funding in research and rapid implementation of best practices are paying off, and people with serious injuries are surviving and rehabilitating, said director of the U.S. Army's Combat Casualty Care Research, or CCCRP, Program Col. Dallas Hack. Joining him was Air Force Col. Todd Rasmussen, CCCRP deput...
Source: Medical Hemostat - August 18, 2013 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
