Showing posts with label hemostat. Show all posts
Showing posts with label hemostat. Show all posts
Sunday, September 20, 2009
Thursday, February 12, 2009
StarFoam Pad from SMI
Starch Medical Inc. have released new footage of their StarFoam plant based hemostatic pad.
SMI came to market with a second generation of plant-based hemostatic solutions which contain no animal or human components in Q4 '08. Their first product, PerClot which has similarities to Medafor's manufactured Arista A.K.A. Hemostase MPH (Cryolife) and Vitasure (Orthovita), is currently sold in European and OUS Markets. The Starfoam product is a wafer-like pad which may be trimmed to suit the surgical procedure. StarFoam utilizes the same AMP technologies as all SMI products and is indicated for a wide range of applications, including but not limited to sternal edge bleeding and unique wound contours. CE mark for StarFoam was awarded in December, 2008.
Company President Mr David Lang comments "I encourage your cost-free evaluation of our innovative hemostatic and woundcare systems. A simple request at info@starchmedical.com will fulfill your product delivery and assure the presence of a Starch Medical representative."
Tuesday, February 3, 2009
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013
WALTHAM, Mass., Feb 02, 2009 /PRNewswire via COMTEX/ -- Growing interest and innovation will drive adhesion barrier market, according to Millennium Research Group
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report, growing surgeon interest in adhesion barriers, combined with numerous upcoming product launches, will fuel revenues in the US adhesion barrier market. Exceeding $550 million by 2013, the adhesion barrier market will experience a compound annual growth rate of almost 25% over the next five years.
It is estimated that the cost of treating adhesiolysis (the surgical removal of adhesions) in the US is over $2 billion annually. Due in part to the narrow range of approved indications for currently available products, the US adhesion barrier market remains underpenetrated; however, interest in these products is expanding rapidly as hospitals and surgeons realize the many benefits of using an adhesion barrier in surgical procedures. This interest will prompt a growing number of competitors to enter the US adhesion barrier market in the coming years.
The arrival of new adhesion barriers will expand indications, and the associated favorable clinical data that supplement product approvals, will boost surgeon awareness and drive adoption. Improved awareness will further be bolstered by continuing innovation and intensifying competition from market competitors, contributing to unit growth and adhesion barrier market expansion over the next five years.
"Following the removal of Gliatech's ADCON-L, FzioMed's Oxiplex/SP adhesion barrier was slated to be the first such product approved for spinal applications in the US," says Kevin Flewwelling, Manager of Orthopedics at MRG. "But, due to the product's unfavorable approval vote from the FDA's Orthopaedic & Rehabilitative Devices Panel in July of 2008, several companies have demonstrated renewed interest in developing an adhesion barrier approved for use in the lucrative US spine market."
MRG's US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 report provides in-depth coverage of the surgical hemostat, internal tissue sealant, and adhesion barrier markets. Competitors covered include Baxter BioSurgery, Covidien, CryoLife, Davol (a subsidiary of C.R. Bard), Ethicon (a Johnson & Johnson company), Genzyme Biosurgery, King Pharmaceuticals, MAST Biosurgery, Orthovita, Pfizer, and many more.
Sunday, April 13, 2008
Tuesday, February 26, 2008
Arista - Plant based Hemostat
Medafor
Arista™AH is an absorbable hemostat, based on Medafor's patented MPH® (Microporous Polysaccharide Hemospheres) Technology that is used in the control of profuse bleeding in general surgery when conventional procedures are ineffective or impractical.
•Direct-from-the-shelf, rapid-delivery hemostat.
•A totally Biocompatible, non-biological, resorbable hemostatic agent (2 Days).
•A fast acting, versatile clotting agent that produces an “instant gelling” followed by the formation of a fibrin mesh.
Arista™AH is an absorbable hemostat, based on Medafor's patented MPH® (Microporous Polysaccharide Hemospheres) Technology that is used in the control of profuse bleeding in general surgery when conventional procedures are ineffective or impractical.
•Direct-from-the-shelf, rapid-delivery hemostat.
•A totally Biocompatible, non-biological, resorbable hemostatic agent (2 Days).
•A fast acting, versatile clotting agent that produces an “instant gelling” followed by the formation of a fibrin mesh.
Oxidized Cellulose
Oxidized cellulose (Surgicel) is widely used for intraoperative hemostasis. When saturated with blood, Surgicel rapidly swells into a gelatinous mass. This property is particularly significant in a confined space containing neural tissue. Six cases of paraplegia following the use of oxidised cellulose in thoracic surgery have been reported.
Above - Hyperdense mass displacing and compressing the spinal cord
There have been several reports of neurological complications associated with the use of oxidized cellulose. There are six case reports of cord compression by a mass of this substance, causing paraplegia following thoracotomy. In all these cases, oxidized cellulose was used to control bleeding at the posterior end of a right T5-T6 interspace incision, in the region of the costo-transverse junction. Migration of an expanded mass of Surgicel through the adjacent intervertebral foramen into the epidural space caused significant cord compression.
Monday, February 25, 2008
Hemostat Manufacturers Links
Links:Advanced Medical Solutions (Winsford, U.K.; http://www.admedsol.com/)Aesculap (Center Valley, PA; http://www.aesculap.com/)Angiotech (Vancouver, Canada; http://www.angiotech.com/)B. Braun (Melsungen, Germany; http://www.bbraun.com/)Baxter Healthcare (Deerfield, IL; http://www.baxter.com/)Chemence (Corby, U.K.; http://www.chemence.com/)Closure Medical (Raleigh, NC; http://www.closuremed.com/)Covidien (Norwalk CT; http://www.covidien.com/)CSL Behring (King of Prussia, PA; http://www.cslbehring.com/)Daiichi Sankyo (Montvale, NJ; http://www.daiichius.com/)Ethicon (Somerville, NJ; http://www.ethicon.com/)GEM (See Synovis Life Technologies)Genzyme Biosurgery (Cambridge, MA; http://www.genzyme.com/)GluStitch (Delta, Canada; http://glustitch.com/)Harvest Technologies (Plymouth, MA; http://www.harvestech.com/)Interpore Cross Medical (Irvine, CA; http://www.interpore.com/)Johnson and Johnson (Somerville, NJ; http://www.ethus.jnj.com/)Kaketsuken (Kumamoto, Japan; http://www.kaketsuken.or.jp/)MedLogic Global (See Advanced Medical Solutions)Nissui Pharmaceutical (Tokyo, Japan; http://www.nissui-pharm.co.jp/)Omrix Biopharmaceuticals (Kiryat Ono, Israel; http://www.omrix.com/)Pharming Group (Leiden, The Netherlands; http://www.pharming.com/)Plasmaseal (San Francisco, CA; http://www.plasmaseal.com/)Protein Polymer Technologies (San Diego, CA; http://www.ppti.com/)Synovis Life Technologies (St. Paul, MN; http://synovislife.com/)SyntheMed (Iselin, NJ; http://www.synthemed.com/)SysCore (E-mail: Helmut.Kranzmaier@cnc-communications.com)ThermoGenesis (Rancho Cordova, CA; http://www.thermogenesis.com/)U.S. Surgical (Norwalk, CT; http://ussurg.com/)
Fibrin Sealants
Most FS products used clinically outside of the U. S. pose certain risks and, as a result, have not been approved by the Food and Drug Administration for use in the U. S. A. For example the FS products available in Europe contain proteins of non-human origin, e. g., aprotinin and bovine thrombin. Consequently, certain individuals are at risk of developing allergic reactions to such non-human protein additives. U. S. Patent No. 6,183, 498 reports that the use of biomedical adhesives have been observed to induce inflammatory tissue reactions.
Both liquefaction processes, however, are associated with significant effort and a considerable time lag before the product can be used in FS products, which can place an already injured patient into a life-threatening situation. Therefore, significant effort has been undertaken to improve the solubility of lyophilized fibrinogen preparations. For example, one manufacturer requires the use of a magnetic stirrer added to the vials of protein to provide significant agitation while heating. This results in dissolution times which are faster than those obtained for the same product without significant mixing, but it still requires 30-60 minutes of preparation time simply to get the fibrinogen ready to use.
Moreover, when heat inactivation is used to inactivate any viruses that may be present in the FS, the process may result in the formation of denatured proteins, which may also be allergenic. For example, the European heat inactivation methods do not inactivate prions which cause bovine spongiform encephalopathy ("mad cow disease"), which has been epidemic recently in bovine herds in European, and hence disease could be carried in the bovine proteins used in the foreign FS products, risking human infection when those products are used for their intended purpose.
Nevertheless, at a sufficiently high fibrinogen concentration, FS preparations provide safe hemostasis, good adherence of the seal to the wound and/or tissue areas, high strength of the adhesions and/or wound sealing, and complete resorbability of the adhesive in the course of the wound healing process (Byrne et al., Br. J. Surg. 78: 841-843 (1991) ). For optimal adhesion, a concentration of fibrinogen of about 15 to 60 mg/ml is required in a ready-to-use tissue adhesive solution (MacPhee, personal communication). The clinical uses of FS products have been reviewed (e. g., by Brennan, Blood Reviews 5: 240-244 (1991) ; Gibble et al., Transfusion 30: 741-747 (1990); Matras, J. Oral Maxillofac. Surg. 43: 605-611 (1985); Lemer et al., J Surg. Res. 48: 165-181 (1990)).
Baxter/Hyland (Los Angeles, Calif.) in conjunction with The American National Red Cross have co-developed Tisseel, the first commercial fibrin sealant to be approved in the United States (see, e. g., U. S. Patent Nos. 6,054, 122; 6,117, 425; and 6,197, 325 (MacPhee et al.). This FS product has advantages over those available in Europe because it is free of bovine proteins. For example, it contains human thrombin, and it contains no aprotinin, thereby reducing the potential for allergenicity. In addition, it is virally inactivated by a solvent detergent method, which produces fewer allergenic denatured proteins.
However, not only does the need to slowly liquefy the protein components cause a significant delay in the formation of the FS preparation, a significant problem arises once fibrinogen is solubilized because its instability results in a tendency to prematurely self- coagulate. In fact, once prepared, the Baxter instructions indicate that the reconstituted solutions can be kept in their respective vials or syringes for a maximum of only 4 hours, after which any unused sealant must be discarded. As a result, the Baxter FS cannot be stored in a ready-to-use condition for any useful length of time.
Both liquefaction processes, however, are associated with significant effort and a considerable time lag before the product can be used in FS products, which can place an already injured patient into a life-threatening situation. Therefore, significant effort has been undertaken to improve the solubility of lyophilized fibrinogen preparations. For example, one manufacturer requires the use of a magnetic stirrer added to the vials of protein to provide significant agitation while heating. This results in dissolution times which are faster than those obtained for the same product without significant mixing, but it still requires 30-60 minutes of preparation time simply to get the fibrinogen ready to use.
Moreover, when heat inactivation is used to inactivate any viruses that may be present in the FS, the process may result in the formation of denatured proteins, which may also be allergenic. For example, the European heat inactivation methods do not inactivate prions which cause bovine spongiform encephalopathy ("mad cow disease"), which has been epidemic recently in bovine herds in European, and hence disease could be carried in the bovine proteins used in the foreign FS products, risking human infection when those products are used for their intended purpose.
Nevertheless, at a sufficiently high fibrinogen concentration, FS preparations provide safe hemostasis, good adherence of the seal to the wound and/or tissue areas, high strength of the adhesions and/or wound sealing, and complete resorbability of the adhesive in the course of the wound healing process (Byrne et al., Br. J. Surg. 78: 841-843 (1991) ). For optimal adhesion, a concentration of fibrinogen of about 15 to 60 mg/ml is required in a ready-to-use tissue adhesive solution (MacPhee, personal communication). The clinical uses of FS products have been reviewed (e. g., by Brennan, Blood Reviews 5: 240-244 (1991) ; Gibble et al., Transfusion 30: 741-747 (1990); Matras, J. Oral Maxillofac. Surg. 43: 605-611 (1985); Lemer et al., J Surg. Res. 48: 165-181 (1990)).
Baxter/Hyland (Los Angeles, Calif.) in conjunction with The American National Red Cross have co-developed Tisseel, the first commercial fibrin sealant to be approved in the United States (see, e. g., U. S. Patent Nos. 6,054, 122; 6,117, 425; and 6,197, 325 (MacPhee et al.). This FS product has advantages over those available in Europe because it is free of bovine proteins. For example, it contains human thrombin, and it contains no aprotinin, thereby reducing the potential for allergenicity. In addition, it is virally inactivated by a solvent detergent method, which produces fewer allergenic denatured proteins.
However, not only does the need to slowly liquefy the protein components cause a significant delay in the formation of the FS preparation, a significant problem arises once fibrinogen is solubilized because its instability results in a tendency to prematurely self- coagulate. In fact, once prepared, the Baxter instructions indicate that the reconstituted solutions can be kept in their respective vials or syringes for a maximum of only 4 hours, after which any unused sealant must be discarded. As a result, the Baxter FS cannot be stored in a ready-to-use condition for any useful length of time.
Baxters Floseal - bovine and human components
Click here for the Instructions Warnings for Baxters Floseal It's a Pdf so you'll need Adobe reader. The video below shows preparation of floseal.
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