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Embosphere Microspheres Details 
Embosphere Microspheres are precisely calibrated, spherical, hydrophilic, micro-porous beads made of an acrylic co-polymer, which is then cross-linked with gelatin. We believe that Embosphere Microspheres are unique because they eliminate aggregation in the catheter, unwanted proximal embolization and unpredictable distal embolization due to particle fragmentation that can occur with alternative embolization products. We believe that Embosphere Microspheres will continue to capture significant market share because of their unique characteristics. We are currently conducting clinical trials of Embosphere Microspheres for uterine fibroid embolization (UFE) in the United States under an Investigational Device Exemption (IDE) granted by the FDA. Phase I was completed in June, 2000. Following positive Phase I three-month post treatment results, we commenced a pivotal Phase II trial. In September, 2001, we announced that all 100 patients in the UFE arm of the trial had been enrolled. Updated trial results reported at SCVIR in April 2002 indicate favorable outcome for Embosphere Microspheres used in uterine fibroid embolization. We are now preparing the data for submission to the FDA. In addition to the FDA 510(k) clearance, we have received CE Mark approval in the European Union and approvals in Canada and Australia which allow BioSphere Medical to sell Embosphere Microspheres for use in general embolization procedures, including uterine fibroid embolization. Click here to view Instructions for Use Click here to view Safety Information Click here for Microcatheter Compatibility Chart Click here to view FDA 510(k) clearance
Embosphere® Microspheres and EmboGold™ Microspheres Indications: We would like to acknowledge and thank Dr. Bob White and Dr. Jeff Stone for their contributions to the content of this website. Products Indications Controlled, Targeted Embolization BioSphere Medical's microspheres are precisely calibrated, spherical, hydrophilic, micro-porous beads made of an acrylic co-polymer (trisacryl) which is then cross-linked with gelatin. This proprietary and patented design allows a more complete and targeted occlusion of the blood vessels feeding a hypervascularized tumor or arteriovenous malformation. Furthermore, the hydrophilic surface and spherical shape prevent aggregation within the catheter lumen and in the vasculature, promoting ease and accuracy of delivery. Finally, the elastic properties of the microspheres also allow the temporary deformation of the sphere, which facilitates the passage through small delivery systems.
Preparation and Administration For details on how to Prepare and Administer
EmboGold Microspheres, Click here for a Microcatheter Compatibility Chart Site Map Contact BioSphere Medical · Privacy Statement Patients Physicians Products Indications Company Other Resources |
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Embosphere®
Microspheres were cleared by the FDA in April 2000 for marketing in the U.S. for
hypervascularized tumors and arteriovenous malformations. Hypervascularized
tumors are characterized by having large numbers of blood vessels feeding them. They
occur in the brain, liver, uterus and many other parts of the body. They may be benign
or cancerous. Arteriovenous malformations are abnormal connections between arteries and
veins which, if untreated, can cause stroke or death. They occur in the brain and other
parts of the body.
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