FDA Wants Medtech to Cut Back on EtO Use

FDA is encouraging manufacturers to reduce the amount of paper included in sterile device packaging in order to reduce the amount of ethylene oxide (EtO) required for effective sterilization. A new voluntary master file program also aims to speed up approval of sterilization site relocations and the implementation of methods that reduce the amount of EtO needed to sterilize FDA-approved medical devices.
 
LivaNova is scrapping its Caisson transcatheter mitral valve replacement program because of continued declines in revenue from its valve business over the last five years. The company plans to restructure and simplify its heart valve manufacturing network, a move that is expected to impact about 150 employees in Italy, Vancouver, and Minneapolis.
 
Paclitaxel-Based Devices Catch a Break
For a while there, things were really looking bad for paclitaxel-coated balloons and paclitaxel-eluting stents. But the narrative has slowly improved and a recent FDA approval marked a turnaround in the paclitaxel story. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.