Okami Medical Secures FDA 510(k) Clearance for SENDERO MAX Delivery Catheter

Okami Medical announced  that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SENDERO MAX Delivery Catheter. This milestone expands Okami's embolization portfolio, which includes the previously cleared SENDERO Microcatheter and LOBO® occluders, providing physicians with a comprehensive, end-to-end, and versatile solution for obstructing blood flow in 1.5mm to 9.0mm peripheral arterial vessels.

The SENDERO catheters are purpose-built and optimized for use with the LOBO occluders.  The design incorporates a hydrophilic coating, stainless steel braid, and radiopaque marker band to optimize trackability and enable precise placement of interventional devices, while a lubricious PTFE inner liner allows for low-friction delivery of interventional devices.

The LOBO patented design with proprietary HDBRAID® technology creates a highly occlusive pore structure that substantially reduces blood flow and accelerates vessel closure.

"We are thrilled to expand our SENDERO catheter portfolio and offer another delivery tool to enable treatment with LOBO vascular occluders. Physicians can now use SENDERO across a wide range of LOBO sizes to treat patients quickly and effectively with a one-and-done solution," said Rhonda Robb, President and CEO of Okami.

Dr. Nima Kokabi, MD, Interventional Radiologist at the University of North Carolina added, "We now have a more complete system with LOBO and SENDERO that allows us to treat patients with a new generation of occlusion and delivery catheter technology. I've successfully used the SENDERO Microcatheter to deliver LOBO-3 and LOBO-5 and am looking forward to the addition of SENDERO MAX to deliver LOBO-7 and LOBO-9. With the expanded SENDERO portfolio, we can move beyond the limitations of traditional coils and vascular plugs, so we can confidently, predictably and rapidly treat our patients in a wide range of cases."