Galil Medical, a global leader in minimally invasive cryotherapy cancer treatments, announced today that they received FDA 510(k) clearance to market their new IceRod® CX Cryoablation Needle.
The new IceRod CX Cryoablation Needle is an innovative technology that combines two different thermal energies in a single ultra-thin cryoablation needle. Cryotherapy, delivered at extremely low temperatures, provides a minimally invasive option to treat tumors for appropriate patients. Cautery, delivered at a high temperature, provides the physician with track ablation options at the end of the procedure.
For customers choosing to use active thaw, the IceRod CX Needle incorporates the company’s exclusive i-Thaw® feature, a proprietary technology that eliminates helium supply costs and reduces cryotherapy procedure set up time for hospitals.
The IceRod CX Needle is designed for use exclusively with Galil Medical’s recently introduced Visual-ICE® Cryoablation System, the latest cryoablation technology and a platform for the company’s future generations of needle products.
“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 Martin J. Emerson, president and chief executive officer of Galil Medical.
The company continues to invest heavily in both new product innovations and clinical research. Galil Medical launched the IceRod® PLUS Cryoablation Needle and the IceEDGE® 2.4 Cryoablation Needle in 2011. The company is developing additional innovative needles and plans to launch these new products within the next several months. Currently, the company has 10 active clinical research studies underway in the prostate, kidney, lung, bone and pain arenas in the U.S., Canada and Europe.
“Galil Medical is the only company solely committed to advancing cryotherapy over a broad range of applications,” Emerson continued. “Introduction of this unique combination of ice and cautery in the IceRod CX Needle builds on the success of multiple recent product launches and affirms our position as the world’s preeminent cryotherapy company. We strive to provide our clinicians with a broad range of product choices, allowing them to select and tailor each clinical solution to match a specific patient need.”