Surefire Medical Receives FDA Clearance for Precision Direct-to-Tumor Embolization Device

WESTMINSTER, Colo.--(BUSINESS WIRE)--Surefire Medical, Inc., developer of a new class of direct-to-tumor treatment delivery devices employed in minimally invasive chemoembolization and radioembolization procedures, announced that the company has received 510(k) FDA clearance for the Surefire Precision. The advanced infusion technology's unique expandable tip increases drug delivery into the tumor while protecting healthy tissue.

"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"

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 percent, and up to 90 percent, compared to use of conventional end-hole catheters in treating primary liver cancer (HCC).

"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," said Alexander Y. Kim, MD, Chief of Vascular and Interventional Radiology at Georgetown University Medical Center.

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 percent of the 2.2 million worldwide cases of primary or secondary liver cancers are operable. Many can, however, be treated with chemoembolization or radioembolization, minimally invasive direct-to-tumor procedures.

"We developed this new drug delivery device for treating the large worldwide primary liver cancer population, and potentially several other clinical applications" said James E. Chomas, CEO of Surefire Medical. "Whether as a first-line treatment, palliative care, or for bridging patients to a liver transplant, the technologically advanced Surefire Precision enables physicians to improve targeting in minimally invasive, direct-to-tumor cancer treatments."

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. The Surefire Infusion System and specialty catheters have received regulatory approval in the U.S., Europe, Canada, Australia, New Zealand and Taiwan.

KOGS Communication
Edna Kaplan, 781-639-1910
[email protected]

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