Originally Published MX January/February 2005
BUSINESS NEWS
Bioabsorbable Stent Gets First Human TrialsThe results of a six-month safety and angiographic follow-up study of patients implanted with a new bioabsorbable coronary drug-eluting stent were reported last November at the annual scientific sessions of the American Heart Association (AHA; Dallas), in New Orleans.
){kind=spacer} |
| The BioMatrix bioabsorbable coronary stent by Biosensors International. (click to enlarge) |
The study was sponsored by Biosensors International Pte Ltd. (Singapore), manufacturer of the BioMatrix stent used in the clinical trials. In contrast to currently approved coronary drug-eluting stents, which use a permanent polymer coating, the BioMatrix stent features a bioabsorbable polymer coating that dissolves during drug release. The resulting solution is made up of all-natural by-products that are metabolized and excreted by the body as carbon dioxide and water.
According to the researchers who reported the study at AHA's annual meeting of 30,000 cardiologists, bioabsorption "may offer potential advantages over permanent stent coatings by eliminating concerns over long-term structural failure or chronic inflammatory effects of the polymer."
The BioMatrix uses Biosensors International's S-Stent bare-metal platform combined with the company's proprietary drug, Biolimus A9, a derivative form of the pharmaceutical sirolimus used by other manufacturers of drug-eluting stents.
 |
| Shulze |
According to Biosensors International's chief technical officer, John Shulze, "Biolimus A9 was the first antirestenotic drug specifically engineered for use on stents. It elutes more rapidly than sirolimus and exhibits more powerful antiproliferative, antiinflammatory and antimigratory effects, which significantly reduce the incidence of restenosis."
The company is moving forward with additional clinical trials of BioMatrix, and expects to file with European regulatory authorities early in 2005 and achieve EU commercialization by year's end. Asian approval is anticipated by 2006. The company has not indicated when BioMatrix will be available in the United States.
Copyright ©2005 MX
