FDA Gives Nod to Cardiovascular Systems’ Replacement Saline Infusion Pump
Cardiovascular Systems has received FDA approval for its premarket approval application supplement for a redesigned saline pump used as part of the company’s Diamondback 360 orbital atherectomy systems.
The 70057-03 saline infusion pump will replace CSI’s 7-10014 saline infusion pump, which the company voluntarily recalled on April 17, 2017.
The saline infusion pump system treats calcified and fibrotic plaque in arterial vessels in the leg and heart in a few minutes.
The company anticipates replacing all recalled units by no later than August 31, 2017. — Cynthia Jessup