Healthcare Industry News:  bioabsorbable 

Device,s Interventional Cardiology

 News Release - May 21, 2009

AMG International Announces the European Regulatory Submission of its Next Generation of Coronary Drug Stents 'Itrix' at European PCR Congress in Barcelona, Spain

German Medical Device Manufacturer AMG International GmbH announced the submission of its proprietary Itrix Stent Technology using its patented biodegradable drug coating.

BARCELONA, Spain, May 21 -- (Healthcare Sales & Marketing Network) -- Three years after the first introduction of Drug Eluting Stents (DES) for the prevention of Heart Disease, Interventional Cardiologists are still in search of a device to address some of the limitations of the 1st technology. Interventional Cardiologists, who treat patients in the estimated 5 Billion (Euro) global coronary stent market, have looked for novel ways to improve the technology for the patients they treat. The first generation drug stents, based on a bio-stable polymer, where the technology and drug remain on the stent for the life of the implant, has common complications associated with latent thrombosis that caused many clinicians to choose other treatment options for their patients. Current DES technology is used in only 50% of the potential cases because of concerns over these complications.

After years of research and clinical work AMG International GmbH has produced the first devices with this novel technology that allows the polymer that holds the drug to absorb into the body along with the drug to ensure that only the metallic part of the stent is left behind reducing the potential for complications associated with stent implants. 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. Through its expanding global network of direct and distribution partners in Europe and Asia, AMG International expects to launch its technology in the later part of 2009 or 1st half of 2010.

The Itrix Platform is equipped with a sophisticated polymer which degrades after the release of the drug Rapamycin, which is well know to be highly efficient in avoiding early thrombotic and re-stenosis events post implantation. The drug is used to stop the body's natural reaction to the implantation of the stent and to help prevent the risk of the artery to clog again.

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 companies Carbon-Ion process to significantly enhance biocompatibility after the drug and the bioabsorbable coating have been absorbed by the body. This Double Protection Technology will assist the Itrix in minimizing the patent risk associated with coronary stent implants and to help avoid late thrombosis and restenosis.

Gunter Deissner, Managing Director for AMG stated that the "Itrix could represent a 1st mover advantage for the company." He went on to comment that he "believes the company could be the 1st to launch a bioabsorbable coated drug eluting stent which could provide the competitive boost a small company needs to compete against some of the industries behemoths."

Doctor Martin Rothman, a Professor of Interventional Cardiology from the London Chest Hospital, and one of the company's medical advisors stated; "This technology could represent a break through in the next generation technology in the treatment of heart disease. With early clinical results looking promising this could significantly reduce the complication rates associated with some of the current technology." He continued to state that, "More randomized clinical trials are necessary to determine the true efficacy of the device in varying patient's population."

Eric Mangiardi MSc., Board of Directors for AMG International, stated that "The Company's years of diligence and focus with its advisory board and core business partners has enabled AMG to realize another first for the company and potentially the industry." He further stated that, "The company was conducting additional trials to determine if the patients could come off of various antiplatelet therapies like Plavex post implant, which would be a real advantage for patients being treated for various cardiac occlusions as well as insurance providers who are hopeful of more cost effective treatments for these patients."

Mr. Deissner then went on to say, "Once regulatory approval was obtained the company would be one of the few if not the only company globally to offer a full range of stents to Interventional Cardiologists that would include multiple drug coated options including one with a biodegradable covering."

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.

AMG International has been developing and commercializing medical technologies for the field Interventional Cardiology since being founded in 1999. Its products are currently available in 26 different countries throughout Europe and Asia and it is in the process of expanding the global commercialization of its technology through increased direct sales and global partner relationships.

Source: AMG International

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