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August 31, 2015
Surefire Precision Direct-to-Tumor Embolization Device Cleared by FDA
September 1, 2015—Surefire Medical, Inc. announced that the company has received US Food and Drug Administration 510(k) clearance for the Surefire Precision direct-to-tumor treatment delivery device. On May 8, Surefire Medical announced European CE Mark approval for the Precision delivery infusion system.
With an expandable tip, the Surefire Precision infusion technology increases drug delivery into the tumor while protecting healthy tissue. The company describes the device as being designed to provide interventional radiologists and interventional oncologists increased selectivity in accessing patients’ smaller peripheral vessels. Recently published clinical data showed that the Surefire technology enabled increased uptake of particles by an average of 68%, and up to 90%, compared to use of conventional endhole catheters in treating primary liver cancer, stated Surefire.
In the company's announcement of the clearance, Alexander Y. Kim, MD, commented, “This is a promising tool that may help to improve clinical outcomes in patients undergoing liver directed intra-arterial therapies for primary and secondary liver cancers.” Dr. Kim is Chief of Vascular and Interventional Radiology at Georgetown University Medical Center in Washington, DC.
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