Endotex Nexstent Carotid Stent and Delivery System and Endotex Carotid Stent and Monorail Delivery System

FDA premarket approval P050025 · Stent, carotid

PMA numberP050025

Approval

Applicant
Boston Scientific
Received
July 15, 2005
Decision date
October 27, 2006 (APPR)
Supplements
6, latest April 9, 2008
Product code
NIM – Stent, Carotid

Official FDA PMA record

Approval order statement

APPROVAL FOR THE ENDOTEX NEXSTENT. THIS DEVICE IS INDICATED FOR TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY DUPLEX ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4MM AND 9MM AT THE TARGET LESION AND A STENOSIS LESS THAN 30MM IN LENGTH.