Technology | June 21, 2012

Surefire Medical Receives FDA Clearance For High-Flow Emobilization Microcatheter

Catheter system's infusion efficiency exceeds 99 percent; designed to significantly reduce backflow

June 21, 2012 — Surefire Medical Inc. announced that it has received 510(k) U.S. Food and Drug Administration (FDA) clearance to market the Surefire high-flow microcatheter, the next generation of the company's infusion technology. The Surefire system is designed to deliver therapy with higher infusion efficiency than conventional microcatheters.

The Surefire microcatheter's expandable tip dynamically expands in reverse flow and collapses in forward flow.

Pre-clinical study results presented at the World Congress of Interventional Oncology (WCIO) in June 2011 found that the Surefire infusion system achieved an average infusion efficiency of 99.1 percent compared to 72.8 percent with a standard infusion catheter.

In addition, an abstract presented by John Louie, M.D. of Stanford University during the 2012 Annual Scientific Meeting for Society of Interventional Radiology (SIR) stated, "In chemoembolization patients, completion C-arm CT imaging suggested a pattern of increased microsphere tumor penetration and contrast retention. In short term follow-up, no clinical evidence of non-target embolization was observed."

Since launching in August 2011, the initial Surefire infusion system has been used in 68 high-volume, top-tier hospitals, primarily in interventional procedures to treat primary and secondary liver cancer.

Surefire's infusion catheters precisely deliver embolic agents through a novel expandable tip that collapses in forward flow and expands to the vessel wall in reverse flow. The Surefire infusion system is designed to increase infusion efficiency and minimize reflux. 

For more information: www.surefiremedical.com

Related Content

Mentice and RAD-AID Collaborate to Improve Access to Interventional Radiology in Resource-constrained Regions
News | Interventional Radiology | April 22, 2019
April 22, 2019 — Mentice AB, provider of endovascular performance solutions, has signed an agreement with the nonprof
Ethicon Launches Global Liver Lesion Ablation Registry
News | Interventional Radiology | April 10, 2019
Johnson & Johnson Medical Devices Companies announced Ethicon has launched a new global registry to collect and...
Society of Interventional Radiology Announces 2019 Gold Medalists
News | Interventional Radiology | April 08, 2019
The Society of Interventional Radiology (SIR) presented its highest honor, the SIR Gold Medal, to Alan H. Matsumoto, M....
Uterine Fibroid Embolization Safer and as Effective as Surgical Treatment
News | Interventional Radiology | April 05, 2019
Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared...
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
Interventional Radiology Treatment for Tennis Elbow Reduces Pain and Inflammation

Image courtesy of Yuji Okuno

News | Interventional Radiology | March 29, 2019
Tennis elbow, a painful chronic condition that affects up to 3 percent of U.S. adults, can be effectively treated...
New Stroke Training Model Improves Access to Life-Saving Care
News | Stroke | March 27, 2019
Training interventional radiologists to perform endovascular thrombectomies results in positive outcomes for patients...
NZ Technologies Announces First Peer-Reviewed Paper on TIPSO AirPad
News | Interventional Radiology | March 25, 2019
NZ Technologies Inc. announced the first published clinical review on its TIPSO technology’s ability to provide...

Photo courtesy of Philips Healthcare

Feature | Interventional Radiology | February 27, 2019 | By Lavi Nissim, M.D.
Picture, for a moment, the following: You are making acquaintance with someone new who is not in the medical professi