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Rafael Medical Technologies Receives Conditional IDE Approval For SafeFlo(R) Retrievable Vena Cava Filter Trial |
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03 Feb 2006 |
BOSTON, USA | Feb. 2, 2006 | Rafael Medical Technologies, Inc. announced today that it has received conditional IDE (Investigational Device Exemption) approval from the U.S. Food and Drug Administration (FDA) to begin the first phase of its U.S. clinical investigation of its SafeFlo(R) Retrievable Vena Cava Filter for the prevention of pulmonary embolism. The trial is designed to evaluate the safety and efficacy of the SafeFlo(R) filter in both permanent and temporary indications. The trial is expected to commence shortly at two medical centers in New York City. A second phase of the trial will commence after completion of the first ten patients in the initial phase of the U.S. study.
European clinical studies conducted to date at several outside-U.S. sites including the University of Vienna under Prof. Johannes Lammer and Queen Margaret Hospital in Edinburgh under Dr. Kieran McBride indicate the potential versatility and safety of the filter as well as its retrievability up to 23 days post implantation. The additional U.S. clinical data will be used to support the company's final device clearance submission to the FDA.
The SafeFlo(R) filter is based on shape-memory nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based designs of filters currently available on the market. SafeFlo(R)'s low-profile design is intended to be vessel-friendly and to afford simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment. These potential attributes are intended to provide the physician with full control of the implantation procedure.
According to Dr. Elchanan Bruckheimer, Rafael Medical's medical director, the clinical data presented to date is very encouraging. "By oversizing the vessel with the filter's double ring anchoring mechanism the SafeFlo(R) filter has the potential for a high level of stability within the cava. A safe and fully repositionable retrievable filter could provide the needed protection at the critical risk stages for patients potentially at risk for developing pulmonary embolism such as hip and knee replacement, trauma and morbid obesity," he stated.
SafeFlo(R), which is CE marked and commercially available in select European markets, is expected to expand the use of vena cava filters on a prophylactic basis among the more than two million patients worldwide who are potentially at risk of developing pulmonary emboli each year.
ABOUT RAFAEL MEDICAL
Founded in 2000, Rafael Medical has developed a novel anchoring system for safely implanting and retrieving a wide 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.
SafeFlo(R) and VascuGrasp(R) are restricted in the U.S. by Federal Law to investigational use only.
For further information visit www.rafaelmedical.com.
SOURCE: Rafael Medical Technologies, Inc. |
