FDA Clears NeuWave Medical’s Certus 140TM 2.45 GHz Ablation System for Use in the Ablation of Soft Tissue
11/2/2010 11:14:49 AM
Madison, WI (October 28, 2010) – NeuWave Medical announced today that the United States Food and Drug Administration (FDA) has issued a 510(k) marketing clearance for the Certus 140TM 2.45 GHz Ablation System to be used in the coagulation of soft tissue.
The Certus 140TM uses 2.45 GHz microwave energy to ablate soft tissue. The system is designed to be used during both minimally invasive percutaneous procedures and open surgery. The Certus 140 is engineered to be the premier soft tissue ablation system available worldwide, maximizing power delivery to create large, predictable ablation zones. The small diameter of the industry leading 17-gauge ablation probes helps decrease bleeding and other complications when compared with larger diameter probes.
A revolutionary CO2-based cooling system enables physicians to safely utilize up to 140 Watts of power on a single channel. Tissu-LocTM technology brings additional differentiation to the Certus 140TM by enabling physicians to secure the probes to the tissue upon placement.
“We are pleased with the recent FDA clearance for the Certus 140TM 2.45 GHz Ablation System.” said Laura King, CEO, NeuWave Medical. “The genesis of the Certus 140 was a collaboration at the University of Wisconsin between the NeuWave founders, Drs. Fred Lee, Jr. and Daniel van der Weide. We believe that the extensive clinical input from multiple physicians during the development of the Certus 140 has resulted in a leadership soft tissue coagulation system that is easier to use, with faster setup and decreased ablation times.”
“The speed, power and ability to create large ablation zones are features which should increase efficiency in the radiology suite and operating room.” said Dr. Lee. “Additionally, the high power and efficient energy delivery are near-ideal for use in coagulation for hemostasis.”
Among the leadership features found on the Certus 140TM are the patented triaxial antenna design, the small diameter 17-gauge needle size for use in minimally invasive procedures, and the excellent visibility under CT and ultrasound to assist physicians during probe placement.
We anticipate the Certus 140TM will be used by Interventional Radiologists and Surgical Oncologists to coagulate and ablate soft tissue.
About NeuWave Medical
NeuWave Medical Inc., develops devices that deliver energy to the human body to treat a variety of serious medical conditions. NeuWave Medical arose as a result of an academic collaboration between engineers and physicians who wished to improve clinical outcomes. We strive to make the highest quality devices that are the products of choice for leading physicians and medical centers around the world. For more information about NeuWave Medical, visit us at www.neuwavemedical.com