| GORE VIABAHN® Endoprosthesis (W.L. Gore & Associates, Inc.) |
| The GORE VIABAHN® Endoprosthesis is a flexible stent-graft designed to treat lower limb peripheral artery disease (PAD). With years of |
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established clinical performance, the GORE VIABAHN® Endoprosthesis is now available with the Carmeda® BioActive Surface technology. In Europe, the device is indicated for endovascular grafting of peripheral arteries. |
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| GORE PROPATEN® Vascular Graft (W.L. Gore & Associates, Inc.) |
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W.L. Gore & Associates is a market leader in vascular grafts worldwide. The GORE PROPATEN® Vascular Graft featuring the Carmeda® BioActive Surface technology has gained a significant market share worldwide since it's market introduction in 2002. |
Numerous studies conducted thus far have shown that the GORE PROPATEN® Vascular Grafts outperform conventional synthetic grafts clinically. The products show sustained thromboresistance and address the problem of thrombotic graft failure. Preliminary results also indicate reduced intimal hyperplasia. |
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GORE PROPATEN® Vascular Grafts configured for Pediatric Shunts are now also avaliable and is the choice of surgeons worldwide for use as shunts in pediatric cardiac procedures.
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Perfusion Systems (Medtronic, Inc.)
Medtronics perfusion systems are marketed worldwide with the Carmeda® BioActive Surface. The coating is recognized as the gold standard in biosurfaces for extracorporeal circuits . There is an extensive body of published research demonstrating its benefits for thromboresistance and biocompatibility in this application. |
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Medtronic's perfusion systems consist of coated tubing, oxygenators, arterial pumps, arterial filters, and perfusion cannulae. Medtronic has recognized the value of having all blood-contacting surfaces of their systems coated with CBAS in what is called "tip-to-tip" coating.
| Ventricular Assist Devices (Berlin Heart GmbH) |
| Berlin Heart is the European market leader for cardiac support systems. They manufacture systems to stabilize cardiac activity in acutely ill patients, both for internal and external use. |
The blood-contacting surfaces of the pumps in their EXCOR® and INCOR® systems features the Carmeda® BioActive Surface technology.
In a controlled study by Berlin Heart comparing CBAS coated and uncoated devices, the CBAS coating provided significantly longer device function times. In addition, a Berlin Heart Ventricular Assist Device (EXCOR) explant showed that about 50% of the initial heparin bioactivity is retained on the surface after 855 days of use in a patient. |
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| Hemodialysis catheters (BARD Access Systems, Inc.) |
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The Decathlon Gold, a long-term hemodialysis catheter with the Carmeda® Bioactive surface is designed to minimize thrombus and fibrin sheath accumulation. |
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The results from the pre-clinical studies of Decathlon Gold bonded with CBAS are outstanding, showing an average reduction |
| in thrombus formation of 95% compared to uncoated control. The product received FDA market clearance in May 2006. |
| Hepacoat, Coronary Stent (Cordis Corporation) |
Cordis chose CBAS as the coating technology for their coronary stent due to its long-lasting effects and protection against subacute thrombosis (SAT).
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| The BX Velocity® stent with Hepacoat was the first coated stent to receive FDA market clearance. The Hepacoat stent was designed to address the challenge of SAT and has been sold and implanted in several hundred thousand patients worldwide over the years. |
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| Since stents remain permanently implanted they are one of the most demanding applications for an implantable coating. |
| Central Venous Catheters (Solomon Scientific) |
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Solomon Scientific offers a full range of CBAS-coated polyurethane catheters in sizes for nearly all laboratory animal species, from mice and rats to dogs, non-human primates, and other large animals.
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| Foley et al describe significant improvements in patency of CBAS-coated catheters vs. uncoated catheters in rat jugular veins (100% vs. 25%). Additionally, histologic exams revealed more advanced and severe lesions in rats with uncoated catheters. Finally, coated catheters were less likely than uncoated catheters to be associated with bacteremia (0% vs. 38%). |