Xtent's Custom NX DES Approved in Europe

March 19, 2009—Xtent, Inc. (Menlo Park, CA) announced that it has received CE Mark approval for its Custom NX drug-eluting stent (DES) system. The approval encompasses both the Custom NX 36 and the Custom NX 60, which are 36- and 60-mm stents, respectively.

According to the company, the Custom NX DES system is designed to enable the treatment of arterial disease based on each patient's individual lesion characteristics by allowing physicians to customize the length and diameter of the stent to the site of the lesion. The stent is coated with Biolimus A9 (Biosensors International Group, Ltd., Singapore) and the biodegradable drug carrier, polylactic acid. The customizable stent system allows the treatment of multiple lesions using one catheter and incorporates a postdilation feature on the delivery catheter. Xtent stated that it has completed four clinical trials with follow-up data up to 4 years. The Custom NX DES System has not been approved for sale in the United States, the company advised.