FDA Clears Rafael Medical's SafeFlo Vena Cava Filter
June 22, 2009—Rafael Medical Technologies, Inc. (Dover, DE) announced last month that the company received marketing clearance from the US Food and Drug Administration (FDA) for its SafeFlo vena cava filter for the permanent implantation of the device in patients at risk of pulmonary embolism. The market clearance follows SafeFlo's clinical evaluation over a 5-year period in a prospective, multicenter clinical study in the United States, the United Kingdom, Austria, Greece, South Africa, and Israel. In Europe, CE Mark approval was granted for the filter in 2004 for both permanent and retrieval indications; however, safety and effectiveness of the device as a retrievable or temporary filter have not been established for FDA approval, the company advised.
According to Rafael Medical, SafeFlo's design provides a double-ring anchoring mechanism as an alternative to the standard strut-based filter designs. This anchoring mechanism design allows for full repositioning before active filter detachment so that the physician has full control of the implantation procedure. The company stated that it is currently focusing on establishing a distribution partnership to bring the SafeFlo to the US market.
"Our experience with SafeFlo has been highly rewarding," commented clinical investigator John Rundback, MD. "The filter's design has added flexibility to the range of deployment and maneuvering possibilities with which we are presently familiar."