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FDA Clears Rafael Medical's SafeFlo Vena Cava Filter



5/13/2009 7:56:21 AM

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DOVER, Del.--(BUSINESS WIRE)--Rafael Medical Technologies, Inc. has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its SafeFlo(R) 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. CE Mark was granted for the filter in 2004 for both permanent and retrieval indications.

The SafeFlo(R) 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(R)'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(R)'s clinical evaluation over a five-year period in a prospective, multi-center clinical study in the U.S., U.K., Austria, Greece, South Africa and Israel. According to 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, "Our experience with SafeFlo(R) 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.”

"We are extremely pleased to have reached this significant milestone," stated Aaron Feldman, President and CEO of Rafael Medical, "Our efforts are currently focused on partnering with a strong player in the U.S. interventional radiology market for bringing SafeFlo(R) to market to the benefit of patients at risk."

About Rafael Medical

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 alike by way of a small-sized delivery system. The SafeFlo(R) filter is the company’s flagship device employing this innovative anchoring system.

For further information contact Aaron Feldman at 011-972-4-6270375 (extension 103) or visit www.rafaelmedical.com.

Contact:

Rafael Medical Aaron Feldman, 011-972-4-6270375 (extension 103)


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