Surefire Medical, Inc. announced today that the company has received 510(k) FDA clearance to market its line of Surefire Angiographic Catheters. Surefire Medical will launch these products in the United States later this year.
Surefire’s Angiographic Catheter line is designed to provide interventional radiologists with far greater flexibility and the highest level of trackability when performing infusion procedures. With a large inner lumen of 0.054 inches, the Surefire Angiographic catheters will be available in a variety of different curve styles for accessing a wide range of patient anatomies.
Interventional radiologists pioneered and continue to specialize in minimally invasive, targeted treatments that once required surgery. They offer the most in-depth knowledge of the least invasive treatments available, coupled with diagnostic and clinical experience across all specialties, according to the Society of Interventional Radiology (SIR).
“Surefire designed our line of Angiographic Catheters to help advance interventional radiology procedures by providing optimal diagnostic imaging and detail during infusion procedures,” said Jim Chomas, CEO of Surefire Medical. “We are excited to offer a suite of products to better meet their clinical needs. Further, the large inner lumen provides a new level of flexibility to these physicians.”
This is the third FDA 510(k) clearance received by Surefire Medical since July 2011. The company also received FDA 510(k) clearance for its Surefire Infusion System and Surefire’s new ST and LT infusion systems, which greatly increase the efficiency of targeted treatments. In addition, Surefire received CE Mark for the Surefire Infusion System in August 2012.
About Surefire Medical
Surefire Medical, Inc., based in Westminster, Colo., was founded in 2009 to develop innovative infusion systems for the interventional radiology and interventional oncology markets. Surefire’s infusion systems are designed to precisely deliver embolic agents through a unique microcatheter with an expandable tip that collapses in forward flow and dynamically expands to the vessel wall in reverse flow in order to increase embolization efficiency, minimize reflux and reduce damage to healthy tissue. For more information, please visit http://www.surefiremedical.com.
Source: Surefire Medical, Inc.