|Xience Xpedition drug eluting stent--courtesy of Abbott.|
Abbott ($ABT) is pursuing an immediate U.S. rollout of its next-generation Xience Xpedition drug eluting stent, backed by a long-awaited FDA approval announced Jan. 3. Four months ago, the product gained a CE mark in Europe.
To get to the regulatory finish line in the U.S., Abbott relied on similar tools that helped launch the everolimus-coated product overseas: data from more than 45,000 patients involving 100 studies, and long-term outcomes trending out for 5 years.
The global stent market is fairly saturated at this point, and Abbott does everything it can to emphasize how Xience Xpedition stands out, a marketing choice that is probably key these days. Xience Xpedition, for example, comes in multiple sizes ranging from 2.25 mm to 4 mm, and comes in both rapid exchange and over-the-wire configurations, according to the company. Sounds a bit like special features in a car. For the stent world, the size options should help surgeons deliver the stent more easily, even for patients that Abbott describes as having "challenging coronary anatomies."
An FDA signoff caps Abbott's global conquest for Xience Xpedition, which is also sold in the Middle East and around the globe.
Another milestone here: This is Abbott's first major FDA approval since the company's Jan. 1 split into two different companies. A revamped Abbott focuses on medical devices, diagnostics, nutritional products and generic drugs. Spinoff AbbVie ($ABBV) now handles the old Abbott's brand-name drug business.
- read the release
Special Report: Xience - The top drug-eluting stents