Rafael Medical Technologies Ltd., an Israeli firm, has obtained FDA approval to market its uniquely shaped IVC filter for permanent implantation in patients at risk of pulmonary embolism, according to the company. The device, first reported on by us about 3 years ago, has been available on the European market since 2004 for both permanent and retrievable indications. The filter employs the company’s proprietary SPACE STATION® intravascular platform for its fixation within the vena cava.
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, 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® 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.”
Press release: FDA Clears Rafael Medical’s SafeFlo® Vena Cava Filter
Product page: SafeFlo® Vena Cava Filter
Flashback: SafeFlo® IVC Filter
(hat tip: Globes Online)
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