CE Mark Approval Granted for Surefire Medical's Next-Generation Infusion System and Specialty Catheters

February 26, 2013—Surefire Medical, Inc. (Westminster, CO) announced CE Mark approval for its Surefire infusion system ST/LT and Surefire specialty catheters for the interventional radiology and interventional oncology markets in Europe during the second quarter 2013, and immediately in New Zealand, where regulatory approval has also been granted. The Surefire infusion system ST/LT has an expandable tip that aims to increase embolization efficiency while reducing reflux into nontarget vessels and tissues, according to the company.

“After using the Surefire infusion system, I can see how the safety profile and improved infusion control offered by the technology will enable interventional radiologists and oncologists to treat more patients who otherwise may not have been treated,” said Tobias Jakobs, MD, of Krankenhaus Barmherzige Brueder in Munich, Germany. “We are continually looking for cutting-edge devices like the Surefire ST/LT and specialty catheters to improve our patients' outcomes.”

In its press release, Surefire Medical noted that in addition to greater safety, the technology delivers more of the embolic agents directly to the target tissue, and that preclinical research published in the Journal of Vascular and Interventional Radiology found that the Surefire infusion system achieved an infusion efficiency of 99.9% compared to 72% with a standard infusion catheter. During an abstract presentation at the 2012 annual scientific meeting for the Society of Interventional Radiology, John Louie, MD, of Stanford University stated, “In short-term follow-up, no clinical evidence of nontarget embolization was observed."