Abbott Laboratories received CE Mark approval in the European Union for its Absorb bioresorbable vascular stent for treating blocked coronary arteries; plus a roundup of other regulatory clearances and approvals from around the world.
Abbott Laboratories (NYSE:ABT) landed approval from European regulators for its drug-eluting bio-resorbable Absorb stent.
The Abbott Park, Ill.-based healthcare products conglomerate said the device, like other stents, works by opening up and providing support to clogged arteries. Unlike its metal counterparts, however, the device is designed to dissolve within approximately two years after implantation, according to Abbott. The device is comprised of polylactide, a bio-compatible substance used in medical implants such as resorbable sutures. Because it eventually disappears, the necessity to treat stent recipients with long-term dual anti-platelet therapy “may be reduced,” the company said.
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Abbott’s planning a commercial launch for the device in Europe by the end of 2012, but said it will make select sizes in limited numbers available this year.
Abbott touts the device as the “world’s first drug-eluting bio-resorbable vascular scaffold for the treatment of coronary artery disease,” but several other companies are also developing bio-resorbable stents. San Diego-based Reva Medical Inc. raised $84.8 million in an initial public offering on the Australian Securities Exchange in December. Arterial Remodeling Technologies, a French company that uses technology developed in part at the Cleveland Clinic, raised $8.5 million in venture capital funding in September to further develop its bio-degradable stents. MultiCell Technologies Inc. (OTC:MCET) is working on a stent that combines two drugs aimed at reducing restenosis — salicylate, aspirin’s active ingredient, and sirolimus. That polymer stent is designed to dissolve completely over the course of a year.
Abbott is planning a 500-patient, 40-site European clinical trial to compare Absorb to Abbott’s Xience Prime drug-eluting stent.
Here’s a roundup of other companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
