The US Food and Drug Administration (FDA) has granted 510(k) approval to Surefire Medical's High-Flow Microcatheter.
The Surefire Microcatheter, comprising of expandable tip, is designed to deliver therapy with higher infusion efficiency than conventional microcatheters.
The expandable tip is designed to expand 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 % compared to 72.8% with a standard infusion catheter.
Surefire Medical CEO Jim Chomas said working with interventional radiologists, the company’s research and development team has created a sleek microcatheter designed to accommodate smaller vessels and selective procedures.
"The addition of the Surefire High-Flow Microcatheter will enable physicians to treat more patients with addressable disease," Chomas added.