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Cost-consequence analysis of a hemostatic matrix (FLOSEAL) alone or in combination for spine surgery patients.
CONCLUSIONS: The use of F versus F+G/T could lead to annual cost savings for US hospitals performing a low- to high-volume of spinal surgeries per year. PMID: 30112922 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - August 17, 2018 Category: Health Management Tags: J Med Econ Source Type: research

Cost effectiveness analysis of sealing hemostat patches vs. standard of care in cardiac surgery.
CONCLUSIONS: This analysis supports the use of HEMOPATCH over SOC in cardiac surgery in European hospitals to improve hemostasis success rates and potential cost offsets from reduced transfusions, complications, and surgical revisions. PMID: 29096598 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - November 5, 2017 Category: Health Management Tags: J Med Econ Source Type: research

Baxter launches next-gen Floseal, Tisseel hemostatic agents
Baxter (NYSE:BAX) today launched next-gen versions of its Floseal and Tisseel hemostatic products, with improved applicability and designs. The Deerfield, Ill.-based company launched the Floseal full sterile preparation system, designed to be prepared by a single person with fewer steps than previous versions. The newly launched hemostatic has the same clearances as prior versions, the company added. “Baxter is committed to introducing innovative products designed to improve patient safety and ease of use. We are excited to bring customer-inspired enhancements to our leading hemostat and sealant portfolio that surge...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Baxter Source Type: news

Variation in hospital resource use and cost among surgical procedures using topical absorbable hemostats
Conclusion: Costs and HRU for patients treated with ORCs were lower than or similar to patients treated with OAHs. Proper selection of the appropriate hemostatic agents has the potential to influence clinical outcomes and treatment costs. Keywords: hemostatics, hemostatic techniques, blood transfusion, health care costs, surgical blood loss
Source: ClinicoEconomics and Outcomes Research - November 5, 2015 Category: Health Management Tags: ClinicoEconomics and Outcomes Research Source Type: research

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

FDA Accepts Biologic License Application for Fibrocaps Hemostatic Agent
The Medicines Company has announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical. The FDA action date (PDUFA date) for Fibrocaps is January 31, 2015. In August 2013, The Medicines Company announced that the Phase III trial, FINISH-3, which studied a total of 719 patients across 54 sites in the U.S. and W...
Source: Medical Hemostat - April 5, 2014 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs

European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Fibrocaps
PARSIPPANY, NJ--(Nov 21, 2013) - The Medicines Company (MDCO) today announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational hemostatic agent Fibrocaps (human plasma-derived fibrinogen and thrombin). Fibrocaps was studied in the 719-patient Phase III FINISH-3 clinical trial as an adjunct to hemostasis in patients undergoing surgical procedures when control of mild or moderate bleeding by conventional surgical techniques is ineffective or impractical. The acceptance of the MAA marks the beginning of the review process in the European ...
Source: Medical Hemostat - November 21, 2013 Category: Technology Consultants Authors: hemostatguy at gmail.com (hemostat guy) Source Type: blogs