Rafael Medical Technologies Ltd. has obtained marketing clearance from the U.S. Food and Drug Administration (FDA) for its SafeFlo Vena Cava Filter.
The approval is for the permanent implantation of the filter in patients at risk of pulmonary embolism; safety and effectiveness as a retrievable or temporary filter have not been established.
The company is currently focused on partnering with a player in the U.S. interventional radiology market for bringing SafeFlo to market.
CE Mark was granted for the filter in 2004 for both permanent and retrieval indications. The market clearance follows SafeFlo’s clinical evaluation over a five-year period in a prospective, multi-centre clinical study in the U.S., U.K., Austria, Greece, South Africa and Israel.
Last year, the company shared that the study, which commenced in July 2003, evaluated 117 patients in eight medical centres.
The SafeFlo filter is an implanted expandable metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. SafeFlo’s design provides a double ring anchoring mechanism as an alternative to the standard strut-based designs of filters available on the market since the 1970s. This anchoring mechanism design allows for full repositioning prior to active filter detachment, providing the physician with full control of the implantation procedure.
