FDA clears IceRod CX cryoablation needle

ARDEN HILLS, MN, USA – Galil Medical has announced the US Food and Drug Administration’s 510(k) clearance for the marketing of the company’s new IceRod? CX cryoablation needle.

The IceRod CX combines two different thermal energies in a single ultra-thin cryoablation needle. Cryotherapy, delivered at extremely low temperatures, is a minimally invasive tumor treatment to appropriate patients. Cautery, delivered at high temperature, provides the physician with track ablation options at the end of the procedure.

The IceRod CX is designed for use exclusively with Galil Medical’s recently introduced Visual-ICE? Cryoablation System.

“We are excited to introduce this innovative product, our fourth product introduction in the past 14 months. The combination of our ultra-thin needles, increased clinician control using our new Visual-ICE System, and now the additional patient benefits with our IceRod CX Needle, creates significant benefits for our customers,” said Galil Medical president and CEO Martin J. Emerson.