The FDA has approved Abbott’s new 2.25mm diameter XIENCE V stent, which the company has dubbed XIENCE nano. Abbott claims that the XIENCE platform is ideal for small vessel angioplasties, which experience restenosis more often than larger vessels.
From the press release:
FDA approval of XIENCE nano was supported by results from the SPIRIT Small Vessel clinical trial, which showed very low late loss (a measure of vessel re-narrowing) of 0.20 mm and a target lesion failure (TLF) rate of 8.1 percent, which is comparable to results observed in the SPIRIT clinical trials with XIENCE V. TLF is defined as a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR).
Press release: Abbott Receives U.S. FDA Approval for XIENCE nano™ to Treat Coronary Artery Disease in Small Vessels…
Product page: XIENCE Everolimus Eluting Coronary Stent System…
Flashbacks: Abbott XIENCE V Drug Eluting Stent Outperforms Boston Scientific’s TAXUS Express2 in Trial; FDA Approves Abbott’s Everolimus Eluting Stent
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