Bleeding Control Articles & Analysis
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Axio Biosolutions receives another FDA clearance for Axiostat Patch for Vascular Bleeding Control
Axio Biosolutions, an integrated wound care company has announced FDA 510(k) clearance of its hemostatic product, Axiostat Patch that helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more. Axiostat Hemostatic Patch is based on a protonated bioadhesive technology which works by providing a strong mechanical barrier to the injury ...
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RevMedx receives CE Mark for XSTAT® injectable hemostatic devices
Revolutionary bleeding control technology will now be available in Europe and other International markets. RevMedx, Inc., a leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XSTAT 30 and XSTAT 12 hemostatic devices in Europe. Unlike traditional wound treatments that may take several ...
By RevMedx
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Medtech Startup Poised for Success
Medtech startup Endomedix is feeling the excitement and satisfaction that follows five years of hard work, and the company is poised for its next key stage of growth. Led by CEO Richard Russo, a veteran at developing products and building businesses, Endomedix has overcome many of the challenges and early missteps that overwhelm most medical device startups. Russo came to Endomedix in 2009 after ...
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EndoClot Expands GI Hemostasis Portfolio With Launch of EndoClot® Adhesive
EndoClot Plus, Inc., a privately held medical device company founded by surgeons and biomaterial scientists announces the CE approval of EndoClot® Adhesive manufactured by EndoClot Plus Co., Ltd. located in Suzhou, China. The product will be made available for discussion during the upcoming Digestive Disease Week held in Washington DC, June 2-5, 2018. EndoClot® Adhesive is a single-use ...
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TX Series added to CoTCCC list of recommended limb tourniquets
RevMedx, Inc., a leader in groundbreaking solutions for the control of severe bleeding, today announced that the CoTCCC has added the TX Series ratcheting tourniquets to its list of recommended Limb Tourniquets. The TX series joins the XSTAT® injectable hemostatic on the TCCC list of recommended hemorrhage control devices for casualty care. Andrew Barofsky, President and CEO of RevMedx, ...
By RevMedx
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Endomedix, Inc. to present its innovative technology addressing the needs of Warfighters at the upcoming Military Health System and Research Symposium 2019 annual meeting
Endomedix, Inc., today announced that it will present its patented revolutionary technology to control bleeding in battlefield injuries at the upcoming Military Health System and Research Symposium (MHSRS) annual meeting. Loss of blood still remains the most common cause of potentially preventable deaths in battlefield casualties, two-thirds of such deaths result from truncal hemorrhage that ...
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RevMedx receives CE Mark for XGAUZE® self-expanding gauze.
Manufacturer of the revolutionary XSTAT technology will now have a second sterile wound dressing available in Europe and other International markets. RevMedx, Inc., a global leader in innovative devices that control severe bleeding, today announced it has received CE (Conformité Européenne) Mark Certification for the XGAUZE wound dressing in Europe. XGAUZE, a Class I sterile ...
By RevMedx
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EndoClot Plus, Inc. Announces FDA Clearance of GI Submucosal Lifting Product
EndoClot Plus, Inc. (EPI), a privately held medical device company announced the FDA 510(k) clearance of EndoClot® Submucosal Injection Agent (EndoClot® SIA) manufactured by EndoClot Plus Co., Ltd. located in Suzhou, China. This product is expected to be commercially available in the United States beginning in May 2020 and later this year in several international markets. EndoClot® ...
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Pfizer and Sangamo Announce Updated Phase 1/2 Results Showing Sustained Bleeding Control in Highest Dose Cohort Through Two Years Following Hemophilia A Gene Therapy
Pfizer Inc. (NYSE: PFE) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today announced updated follow-up data from the Phase 1/2 Alta study of giroctocogene fitelparvovec, an investigational gene therapy for patients with moderately severe to severe hemophilia A. The Alta study data, in patients with severe hemophilia A, are being presented today at the 63rd American ...
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Instylla announces positive results from preclinical studies of Embrace™ Hydrogel Embolic System in hemorrhage models
Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced two publications that evaluated the Embrace™ Hydrogel Embolic System (HES) in preclinical porcine hemorrhage models. In a Journal of Vascular and Interventional Radiology (JVIR) publication, Dr. Gandras et al. evaluated[i] the ability of Embrace HES to ...
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New Publication Concludes Gauss Surgical’s Triton System Associated with Earlier Postpartum Hemorrhage Intervention and Reduced Costs
Gauss Surgical, a health technology company, announced that a new study published in the International Journal of Obstetric Anesthesia concluded that the use of the company’s Triton system to monitor maternal blood loss during labor and delivery was associated with earlier postpartum hemorrhage intervention and cost savings. Researchers at Mount Sinai Hospital (New York, NY) studied over ...
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Polyganics Awarded €1.2 Million for Clinical Development of Liver and Pancreas Sealant Patch
Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, announced today that it has received EUR 1.2 million in funding from the European Fund for Regional Development (EFRO) through the Northern Netherlands Alliance (SNN) and the city and province of Groningen, to support clinical validation of its Liver and Pancreas Sealant Patch. ...
By Regenity
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First Patients Treated in First-in-Human Trial for ACTISEAL – Polyganics’ Innovative Liver and Pancreas Sealant Patch
Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, today announced treatment of the first patients in its first-in-human study for ACTISEAL®, its Liver and Pancreas Sealant Patch. The ‘SHIELDS’ trial is a prospective, multicenter study, evaluating the safety and performance of ACTISEAL® in reducing fluid ...
By Regenity
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Life-Changing Watchman Procedure for Patient with Kidney Disease
Like many people with atrial fibrillation (AFib), Sheldon Kittelson of Clarkfield, Minnesota, felt trapped between the fear of having a stroke and the fear of spending a lifetime on blood thinners. For people with AFib, blood doesn’t flow through the heart normally, which can result in a clot forming in the left atrial appendage (LAA) that can break loose and lead to a stroke. ...
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Grifols reaches revenue of EUR 5,100 million, a 13.6% increase, and raises its profits to EUR 625 million
Revenue increases 13.6% (9.2% cc) as a result of the sustainable growth strategy, with advances in all divisions and regions Bioscience leads the growth with EUR 3,994 million of revenue (13.6%; 8.9% cc). Diagnostic and Hospital continue to make progress with sales of EUR 734 million (4.5%; 1.1% cc) and EUR 134 million (12.5%; 12.1% cc), respectively. Bio Supplies achieves EUR 267 million in ...
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