Xtent, a medical device company, has received CE Mark approval for its Custom NX drug-eluting stent system.
The CE Mark indicates that the Custom NX drug-eluting stent (DES) system may be marketed in the EU as well as other countries that recognize the CE Mark and that the product complies with applicable safety and quality standards. The approval includes both the Custom NX 36, a 36mm stent and the Custom NX 60, a 60mm stent.
According to Xtent, the Custom NX DES system is designed to enable a more personalized approach to the treatment of arterial disease based on each patient’s individual lesion characteristics. The Custom NX delivery system allows physicians to customize the length and diameter of the stent at the site of the lesion.
Gregory Casciaro, president and CEO of Xtent, said: Receipt of the CE Mark is an important accomplishment and a validation of the strength of our clinical data. It is a tribute to the hard work and dedication of our people as well as the collaborative effort of our drug coating provider, Biosensors. We look forward to the opportunity to bring this new technology to patients and physicians throughout the EU.