ANNULOPLASTY RING CLASS II STATUS SUPPORTED BY IMPROVED SUCCESS RATES -- HIMA PETITION; PERFORMANCE TESTING, LABELING SUGGESTED AS SPECIAL CONTROLS
This article was originally published in The Gray Sheet
Executive Summary
Advances in the technology and techniques for heart valve repair procedures warrant Class II status with special controls for annuloplasty rings, a Health Industry Manufacturers Association task force says in a Feb. 14 downclassification petition filed on behalf of Sulzer CarboMedics, St. Jude Medical, Medtronic and Sorin Biomedical.