Technology | May 22, 2009

FDA Clears Rafael Medical’s SafeFlo Vena Cava Filter

May 22, 2009 - Rafael Medical Technologies Inc. said this week it received FDA clearance for its SafeFlo Vena Cava Filter.

The clearance is for the permanent implantation of the filter in patients at risk of pulmonary embolism. CE mark was granted for the filter in 2004 for both permanent and retrieval indications.

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 market clearance follows SafeFlo's clinical evaluation over a five-year period in a prospective, multicenter clinical study in the U.S., U.K., Austria, Greece, South Africa and Israel.

"Our experience with SafeFlo has been highly rewarding. The filter’s design has added flexibility to the range of deployment and maneuvering possibilities with which we are presently familiar,” said clinical investigator, Dr. John Rundback, director of the Interventional Institute at Holy Name Hospital in Teaneck, New Jersey and associate professor of clinical radiology at Columbia University College of Physicians and Surgeons.

Founded in 2000, Rafael Medical has developed a double ring anchoring system for implanting a range of intravascular devices in a minimally invasive manner. Based on the technology, diagnostic and therapeutic devices can be delivered into small and large blood vessels by way of a small-sized delivery system. The SafeFlo filter is the company’s flagship device employing this anchoring system.

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