AMG International Seeks CE Mark for Coronary Stent With Bioabsorbable Polymer
May 26, 2009 – AMG International GmbH last week submitted its second-generation drug-eluting stent (DES), Itrix, for regulatory review in Europe. The stent offers a bioabsorbable polymer that holds the drug.
After the polymer dissolves, the metallic part of the stent is left behind, reducing the potential for complications associated with vessel irritation and thrombosis caused by DES polymer coatings.
Working with the guidance of its global medical advisory board of interventional cardiologists, AMG has completed its pivotal study and is awaiting CE approval to initiate the commercialization of its latest innovation. AMG expects to launch its technology in the later part of 2009 or first half of 2010.
The Itrix platform is equipped with a sophisticated polymer that degrades after the release of the drug rapamycin, which the company said is efficient in avoiding early thrombotic and restenosis events post implantation. The drug is used to stop the body's natural reaction to the implantation of the stent and to help prevent restenosis.
The choice of drug as well as the time the polymer will stay on the stent is adjusted to maximize the absorption of the drug and to ensure the best potential results. The stent platform that is left is a proprietary technology that uses the company’s carbon-ion process to significantly enhance biocompatibility after the drug and the bioabsorbable coating have been absorbed by the body.
"This technology could represent a breakthrough in the next generation technology in the treatment of heart disease,” said Dr. Martin Rothman, a professor of interventional cardiology from the London Chest Hospital, and one of the company's medical advisers. “With early clinical results looking promising this could significantly reduce the complication rates associated with some of the current technology. More randomized clinical trials are necessary to determine the true efficacy of the device in varying patient’s population."
The company's clinical studies to date indicate no late stent thrombosis at two years post implant and other implant-associated complications are comparable to that of various market leading published studies.
For more information: www.amg-erle.de
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