|Abbott's Absorb device--courtesy of Abbott Laboratories.|
Abbott ($ABT) this week launched a massive U.S. clinical trial for its Absorb drug-eluting bioresorbable vascular scaffold, with plans to enroll up to 2,250 patients. If the results pass muster, they'll support the company's FDA approval bid.
No such product is approved yet in the United States, though Abbott late last year began shipping Absorb in Europe as well as some Latin American and Asian countries, including India. Absorb represents a real advance for the stent industry--it behaves like a regular vascular stent, but is resorbed by the body over time after fulfilling its initial task of restoring blood flow to a blocked vessel. A dissolving stent should be safer than regular drug-eluting stents that stay in the body, which can cause chronic inflammation and boost the risk of new blood clots.
Absorb's secret: It's made of polylactide, the same material used for dissolving medical sutures. It's also the first stent of its kind to hit the commercial market, though others are trying to develop bioresorbable stents.
Abbott's new randomized, controlled trial will primarily involve U.S. clinical sites. Dubbed ABSORB III, the effort will compare Absorb to the company's own Xience drug eluting stents.
Abbott isn't hedging its bets with Absorb. Five previous studies in more than 20 countries helped support the product's international launch late last year. Translated, that means 1,000 patients in more than 20 countries have been treated with the Absorb stent. The company also notes it has data out to 5 years for the initial patients. And with the U.S.-focused study now under way, Abbott will be gathering even more data. The FDA approval process can be rigorous, which means the more data Abbott can show the agency the better the approval prospects for Absorb will be. And the U.S. trial--with its large size and scope--will only help that process when the time comes.
- read the release
Abbott launches dissolving stent abroad
JAMA study: Biodegradable drug-eluting stent safer than bare-metal variety
Abbott launches U.S. sales for next-gen Xience stent