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In Brief: Boston Scientific's NIR ON Ranger

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific's NIR ON Ranger: Premarket approval application for the company's NIR coronary stent mounted on an over-the-wire catheter is submitted to FDA. Data from the NIRVANA stent trial, which was conducted by Boston Scientific's Medinol division, were submitted in support of the PMA. Boston Scientific also completes enrollment for a separate patient registry related to a NIR ON Ranger rapid-exchange delivery system that the company claims does not infringe patents held by competitors Guidant and Pfizer's Schneider unit. Results of the registry will be submitted as a PMA supplement, the company says...

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