Abbott (NYSE:ABT) says it won pre-market approval from the FDA for its Xience Prime drug-eluting stent, firing the latest salvo in the long-running stent wars with Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT).
The regulatory green light means the Xience Prime – the latest design iteration of Abbott’s Xience platform, using the same everolimus drug and bio-compatible polymer – is cleared for market in the U.S. , "Europe, the Middle East and most of Asia," according to a press release.
"Xience Prime features one of the thinnest drug eluting stent struts available while maintaining radial strength to support the vessel," according to the release.
That’s an important point, given news breaking today of an Irish study showing that the thinner profiles and increased flexibility of such next-generation stents may not be as strong as their thicker forbears.
Researchers at the Belfast Health & Social Care Trust looked at stents made by Abbott, Medtronic, Boston Scientific, Johnson & Johnson (NYSE:JNJ) and Biosensors International Group. For example, the scientists compared the 81-micrometer thickness of the Xience Prime and Xience V stents with J&J’s 140-micrometer Cypher and Cypher Select Plus DES models.
The later-model stents could warp, possibly leading to stent thrombosis and a “potentially catastrophic late complication,” according to the Irish research team, who noted that a vulnerable blood vessel area intended to be covered by the stent may be left exposed and unsupported.
Early last month, Abbott enrolled the first patient in its global Excel trial, the largest clinical study to date examining surgical and stenting outcomes in patients with unprotected left main disease.
Abbott will compare the Xience Prime and Xience V stents with coronary artery bypass grafting in a multi-center, randomized prospective trial spanning more than 2,6000 patients and up to 165 medical centers in 18 countries.