Surefire Medical receive the CE mark for its infusion system and specialty catheters


On the 26 February 2013 Surefire Medical, the developer of a new class of infusion systems designed to maximise targeted delivery of embolization agents without reflux, announced CE mark approval for its Surefire Infusion System ST/LT and Surefire Specialty Catheters. The company will launch its latest products in Europe during the second quarter 2013.

The Surefire Infusion System ST/LT, the next generation of the company’s novel suite of microcatheters for the interventional radiology and interventional oncology markets, has a unique expandable tip that dynamically expands in reverse flow and collapses in forward flow, significantly reducing reflux into non-target 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 technology will enable interventional radiologists and oncologists to treat more patients who may have otherwise not been treated,” said Tobias Jakobs, Krankenhaus Barmherzige Brueder, Munich, Germany. “We are continually looking for cutting-edge devices like the Surefire ST/LT and specialty catheters to improve our patients’ outcomes.”

In addition to greater safety, Surefire’s technology is intended to deliver more embolic agents directly to the target tissue. Pre-clinical research presented at the World Congress of Interventional Oncology (WCIO), 14–19 June 2012, Chicago, USA, demonstrated that the Surefire Infusion System achieved an average infusion efficiency of 99.1% compared to 72.8% with a standard infusion catheter.

“In chemoembolization patients, completion C-arm CT imaging suggested a pattern of increased microsphere tumor penetration and contrast retention,” said John Louie, Stanford University, Stanford, USA, during an abstract presentation at the for Society of Interventional Radiology (SIR) Annual Meeting (24–29 March 2012, San Francisco, USA). “In short term follow-up, no clinical evidence of non-target embolization was observed.”

“Working with key interventional radiologists, our research and development team created a highly trackable, sleek microcatheter designed to accommodate smaller vessels and selective procedures,” said Jim Chomas, CEO of Surefire Medical. “Surefire Medical’s suite of products is setting a new standard for delivery of embolic agents in a wide range of infusion procedures—allowing physicians to deliver the prescribed dose precisely and safely to patients.”

Specialty Catheters

Surefire’s Specialty 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 Specialty catheters will be available in a variety of different curve styles for accessing a wide range of patient anatomies, according to the company.

“Surefire designed our line of Specialty Catheters to help advance interventional radiology procedures by providing optimal diagnostic imaging and detail during infusion procedures,” said Chomas. “We are excited to offer a suite of products that is rapidly proving to better meet clinical needs. Further, the large inner lumen provides a new level of flexibility to these physicians.”

Regulatory approval in New Zealand

The company also received regulatory approval from New Zealand for the Surefire Infusion System ST/LT and the Specialty Catheters. Surefire will launch these products in New Zealand immediately.

The company received CE Mark approval for the initial Surefire Infusion System in September 2012. In addition, Surefire has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Surefire Infusion System in July 2011, the Surefire Infusion System ST/LT in June 2012 and the Surefire Specialty Catheters in October 2012.