FDA Clearance for SafeFlo Vena Cava Filter

Rafael Medical Technologies, a developer of intravascular devices, has received marketing clearance from FDA for its SafeFlo vena cava filter.

The clearance 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 market clearance follows SafeFlo's clinical evaluation over a five-year period in a prospective, multi-center clinical study in the US, UK, Austria, Greece, South Africa and Israel.

According to Rafael Medical Technologies, 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, the company said.

Aaron Feldman, president and CEO of Rafael Medical, said: "We are extremely pleased to have reached this significant milestone. Our efforts are currently focused on partnering with a strong player in the US interventional radiology market for bringing SafeFlo to market to the benefit of patients at risk."