Galil Medical, a global leader in minimally invasive cryotherapy cancer treatments, announced today that they received FDA 510(k) clearance to market their new Visual-ICE® Cryoablation System. The company will showcase their new system at the Society of Interventional Radiology meeting this week in San Francisco, as well as at the upcoming European Congress of Interventional Oncology meeting, the American Urological Association meeting and the 5th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer.
The new system capabilities promote more precision and flexibility for the user, allowing for increased control over the shape and size of individual iceballs. Further, the system simplifies and shortens cryoablation procedures, including the operation and monitoring of the procedure from a large, single touch-screen.
The Visual-ICE Cryoablation System is the first oncology focused cryoablation system introduced in over 6 years, engineered with multiple physician specialties in mind, and will be the platform technology for the company’s next generation needle products.
Faster overall procedure times, the ability to concurrently treat larger and/or multiple lesions are some of the additional features of the company’s new Visual-ICE system. The new system will also leverage i-Thaw®, the company’s proprietary argon-only needle technology, resulting in lower operating costs for hospitals.
The company continues to invest heavily in new product innovations and clinical research. The Visual-ICE Cryoablation System further enhances Galil Medical’s position as the preeminent cryotherapy company in the world. Galil Medical’s collaborative approach with its customer base was evident in the development process for Visual-ICE, as countless hours were invested in feedback sessions with physicians, nurses and technicians to better understand their specific needs.
“The Visual-ICE System represents the latest example of our commitment to advancing cryotherapy,” commented Martin J. Emerson, President and CEO of Galil Medical. “Our goal with the Visual-ICE System is to enhance the user experience. Through state of the art software and technology, this new system will provide the user with more intra-procedural precision and control. We look forward to meeting the needs of our physician customers for many years to come.”
Galil Medical launched the IceRod® Plus Cryoablation Needle and the IceEDGE® Cryoablation Needle in 2011. The company is developing many more new needles and plans to launch four new needles within the next 18 months.
“Galil Medical is the only company solely committed to advancing cryotherapy over a broad range of applications,” Emerson continued, “We believe that the introduction of the Visual-ICE System will further solidify our position as the world’s preeminent cryotherapy company. Our goal is to provide our clinicians with a broad range of product choices, supported by robust clinical data, allowing them the flexibility to treat a wider range of patients.”