Surefire gets FDA nod for Precision direct-to-tumour embolization device


Surefire, a developer of a new class of direct-to-tumour treatment delivery devices employed in minimally invasive chemoembolization and radioembolization procedures, announced  that the company has received  US510(k) FDA clearance for Precision. The infusion technology’s unique expandable tip increases drug delivery into the tumour while protecting healthy tissue.

In clinical data recently published in the Journal of Vascular and Interventional Radiology (JVIR), Surefire technology enabled increased uptake of particles by an average of 68%, and up to 90%, compared to use of conventional end-hole catheters in treating primary liver cancer (HCC). 

“This is a promising tool which may help to improve clinical outcomes in patients undergoing liver directed intra-arterial therapies for primary and secondary liver cancers,” said Alexander Y Kim, chief of Vascular and Interventional Radiology, Georgetown University Medical Center, Washington, DC, USA.

The newest infusion system from Surefire is designed to provide interventional radiologists and interventional oncologists with far greater selectivity in accessing patients’ smaller peripheral blood vessels.

Fewer than 20% of the 2.2 million worldwide cases of primary or secondary liver cancers are operable.  Many can, however, be treated with chemoembolization or radioembolization.