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

Surefire Medical, developer of a new class of direct-to-tumor treatment delivery devices employed in minimally invasive chemoembolization and radioembolization procedures, has received FDA approval for the Surefire Precision. The company in a press release says that the advanced infusion technology’s unique expandable tip increases drug delivery into the tumor while protecting healthy tissue.

In recently published clinical data, 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."

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“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,” said said James E. Chomas, CEO of Surefire Medical.