FDA Clears Echo Distal Access Guiding Catheter

The U.S. Food & Drug Administration has cleared Nfocus Neuromedical Inc.'s novel guiding catheter, the Echo Distal Access Guiding Catheter, for marketing in the US.

"Nfocus works closely with key clinical opinion leaders to direct all of our design and development projects, and the Echo is our latest success story," says President and CEO Martin Dieck. "Our advisors identified the need for a guiding catheter with improved performance and our team has responded with Echo."

The Echo Distal Access Guiding Catheter has been cleared by the FDA for introduction of interventional and/or diagnostic devices in peripheral, coronary and neurovascular vessels. A high-quality guiding catheter is required in today's advanced and complex endovascular procedures to assist in reaching the target vessel with stents and other operative devices. The guiding catheter must be atraumatic and flexible within the distant and smaller target vessel - yet provide stable and firm support in the larger vessels where the device enters the body.

"The Echo is a stable platform for placing today's most advanced interventional devices and its unique construction gives it the ability to maintain a round lumen to enable endovascular procedures in very far-reaching vessel locations," continued Mr. Dieck.

"Combined with Echo's earlier CE Mark approval, the US FDA clearance gives Nfocus the ability to enter the top end of interventional guiding catheter markets worldwide. Endovascular surgeons and interventional neuroradiologists will appreciate the supple distal end which resists ovalizing of the lumen and the exceptional support of the proximal section - both produced by the unique catheter skeleton."