For information regarding clinical, distribution or partnership opportunities for SafeFlo® please contact Rafael Medical.
Overview
Rafael Medical's initial device is SafeFlo®, vena cava filter indicated for permanent placement for the management and prevention of Pulmonary Embolism, a condition that has been estimated to cost the U.S. healthcare system over $1.5 billion annually.
SafeFlo® utilizes shape memory alloys and is based on a highly innovative spiral design that employs the company's SPACE STATION® intravascular platform for its fixation within the vessel.
SafeFlo® is unique in that it provides an alternative anchoring mechanism to the standard linear "legs and hooks" or "box and hooks" designs of existing filters currently available on the market.
Features & Benefits
The SafeFlo® Vena Cava Filter offers two-levels of anchoring with a platform that oversizes the vessel preventing migration while maintaining vessel integrity1.
A 5-petalled flower loop configuration provides highly effective clot capture of clinically significant clots2. The configuration is designed to sit centrally in the lumen minimizing impedance to flow with a low incidence of thrombosis3.
The SafeFlo® filter offers the following advantages:
Versatility and Control
The SafeFlo® filter can be fully deployed and then collapsed back into its delivery sheath and redeployed in a different position from both the femoral and jugular approaches prior to active detachment from the delivery system. This minimizes the disadvantages and risks associated with imperfect filter positioning.
Vessel Friendly
The SafeFlo® filter's fixation is by diffuse pressure on the full circumference of the vessel wall provided by the rings of the anchoring platform.
Sizing
The SafeFlo® filter is offered in three sizes (Small, Medium, Large) covering a range of vessel diameters between 15mm and 27mm allowing for vessel-compatible anchoring. All sizes can be deployed from the jugular or femoral approaches using a low profile 6F delivery system.
1 Bench testing, animal and clinical study data on file. 2 Bruckheimer E. et al. In vitro evaluation of a retrievable low-profile nitinol vena cava filter. JVasc Interv Radiol 2003 14: 469-474. 3 Animal and clinical study data on file.
SafeFlo® is CE Marked and approved for sale in the European Community for both permanent and temporary use.
Precautions:
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
The safety and effectiveness of the SafeFlo® Vena Cava Filter for use as a retrievable or temporary filter have not been established.
SafeFlo®
