Two years behind Europe, the FDA has issued Abbott clearance to market the company’s XIENCE PRIME everolimus eluting coronary stent.
The device features high strength and flexibility and the same biocompatible and mechanically dynamic polymer as the company’s popular XIENCE V stent.
XIENCE PRIME is based on the stent design of the MULTI-LINK family. It utilizes cobalt chromium technology and features a “peak-to-valley” mechanical design that imparts longitudinal strength and stability to the stent. To date, the stents based on the MULTI-LINK design – including VISION® , XIENCE V, PROMUS® and XIENCE PRIME – represent more than 300 million implant months, which is a measure of the clinical experience that supports this stent design. In addition, XIENCE PRIME features one of the thinnest drug eluting stent struts available while maintaining radial strength to support the vessel, and it provides excellent visibility under X-ray during stent implantation procedures. XIENCE PRIME is offered in long lengths up to 38 mm.
FDA approval of XIENCE PRIME was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated XIENCE PRIME in 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure (TLF) at one year. Stent thrombosis rates at one year also were very low. The full results from the SPIRIT PRIME study will be presented by Dr. Costa on Tuesday, Nov. 8, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
Press release: Abbott Receives U.S. FDA Approval for Next-Generation XIENCE PRIME™ Drug Eluting Stent
Product page: XIENCE PRIME…
Flashback: New Xience Abbott Stent Gets EU OK
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