Surefire Medical Receives CE Mark Approval for Next Generation Infusion System and Specialty Catheters
Global expansion continues with regulatory approval in New Zealand
WESTMINSTER, Colo., Feb. 26, 2013 /PRNewswire/ — Surefire Medical, Inc., the developer of a new class of infusion systems designed to maximize targeted delivery of embolization agents without reflux, today announced CE Mark approval for its Surefire Infusion System ST/LT and Surefire Specialty Catheters. The company will launch its latest line of microcatheters and 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 a novel expandable tip that increases embolization efficiency while reducing reflux into non-target vessels and tissues.
“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, M.D. 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.”
Growing body of clinical evidence
In addition to greater safety, Surefire’s breakthrough technology delivers more of the embolic agents directly to the target tissue. Pre-clinical 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.
“In short-term follow-up, no clinical evidence of non-target embolization was observed,” said John Louie, MD of Stanford University during an abstract presentation at the 2012 Annual Scientific Meeting for Society of Interventional Radiology (SIR).
Last year Surefire received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Surefire Infusion System ST/LT and the Surefire Specialty Catheters.
“We designed the sleek, highly trackable Surefire microcatheters and specialty catheters to provide interventional radiologists with far greater flexibility and the ability to perform a wide range of infusion procedures,” said Surefire Medical President and CEO Jim Chomas. “They allow physicians to deliver the prescribed dose precisely and safely to patients.”
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 maximize targeted delivery, minimize reflux and reduce damage to healthy tissue. For more information, please visit www.surefiremedical.com.
SOURCE Surefire Medical, Inc.