Reverse Medical ReFlex Catheter Cleared in US and Europe

April 26, 2011—Reverse Medical Corporation (Irvine, CA) announced that it has received US Food and Drug Administration 510(k) clearance to market the ReFlex line of intracranial catheters for distal neurovascular access and microcatheter therapeutic delivery. The ReFlex catheter is designed to provide endovascular intracranial access during interventional neurovascular procedures. The company plans to immediately commence commercialization in the United States through its direct sales force.

On April 5, Reverse Medical announced that it had received CE Mark approval for its ReFlex A+ catheter for intracranial distal access, delivery, and aspiration. In Europe, the ReFlex A+ catheter is approved for 4-, 5-, and 6-F sizes, with straight and multipurpose curve-tip configurations. The company commenced European and Asian commercialization through international distributors in territories that recognize the CE Mark.

“The ReFlex catheter performed beautifully in my recent challenging bifurcation aneurysm case,” commented interventional neuroradiologist Satoshi Tateshima, MD, of the Ronald Reagan UCLA Medical Center at the University of California, Los Angeles. “The large 0.072-inch lumen provided great contrast injection capability with two microcatheter systems in place. I could clearly visualize four middle cerebral artery branches throughout the procedure, helping to ensure a safe and highly effective clinical result.”

Demetrius Lopes, MD, an endovascular neurosurgeon at Rush University Medical Center in Chicago, added, “My initial clinical cases with ReFlex went extremely well. One case in particular presented with very impressive anatomy to overcome, with excellent distal position enabling me to accurately place three Pipeline devices (Pipeline embolization device, Covidien, Mansfield, MA). The ability to simultaneously deliver Pipeline, coils, and inject contrast through ReFlex is unprecedented.”

In Europe, Vitor Mendes Pereira, MD, of the neurointerventional unit at Switzerland's University Hospital of Geneva, stated, “From my initial clinical experience, the ReFlex offered superior performance in terms of flexibility for distal navigation, support, kink resistance, and aspiration. The larger internal lumen allows me to inject contrast during dual microcatheter manipulations, clearly visualizing the target anatomy. The ReFlex A+ catheter will be useful in cases when accurate positioning is critical, such as during stent or aneurysm flow diverter implantation. The distal navigation and larger lumen size of the ReFlex enabled more effective aspiration, which should optimize acute stroke treatment.”