Okami Medical's SENDERO MAX Catheter Gains FDA Clearance, Expanding Treatment Options

Okami Medical Expands Portfolio with the SENDERO MAX Delivery Catheter

In an exciting development for medical professionals, Okami Medical has recently announced that it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SENDERO MAX Delivery Catheter. With this significant milestone achieved, Okami is set to enhance its embolization product offerings, now including the SENDERO MAX in addition to the previously approved SENDERO Microcatheter and LOBO® occluders. This expansion aims to provide physicians with a more comprehensive and effective solution for managing blood flow obstruction in peripheral arterial vessels ranging from 1.5mm to 9.0mm.

The SENDERO catheters are meticulously designed to function optimally with LOBO occluders, ensuring a seamless integration of technology for healthcare professionals. The catheter boasts a unique hydrophilic coating, a stainless steel braid for enhanced durability, and a radiopaque marker band that guarantees superior trackability. These features collectively facilitate the precise placement of interventional devices. Moreover, the inclusion of a lubricious PTFE inner liner guarantees low-friction delivery, thereby improving the overall efficacy during critical procedures.

One of the standout features of the LOBO occluders is their patented design that incorporates proprietary HDBRAID® technology. This technology creates a distinctive occlusive pore structure that not only significantly reduces blood flow but also accelerates vascular closure, significantly improving patient outcomes.

Rhonda Robb, President and CEO of Okami Medical, expressed excitement over this advancement, stating, "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."

The benefits of the SENDERO MAX were echoed by Dr. Nima Kokabi, an Interventional Radiologist at the University of North Carolina, who emphasized the advanced capabilities of the system. Dr. Kokabi stated, "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, allowing us to confidently and predictably treat our patients across a wider array of cases."

Okami Medical, Inc. was founded in 2017 with a mission to address the continual evolution of healthcare needs. The company is dedicated to developing innovative and versatile medical devices that cater to the occlusion of peripheral vessels. Founded by the team at Inceptus Medical, a noted medical device incubator, Okami Medical is bolstered by a board of experienced directors and talented investors, including Vensana Capital and U.S. Venture Partners (USVP).

As healthcare continues to advance, the introduction of SENDERO MAX marks a pivotal moment for Okami Medical as it reflects their commitment to equipping healthcare providers with top-tier tools aimed at improving patient care. For more information on their products and mission, visit www.okamimedical.com.

In conclusion, as the demand for sophisticated medical devices grows, Okami Medical's new SENDERO MAX Delivery Catheter stands as a testament to innovation in the field of vascular treatments. With continuous advancements such as this, hospitals and patients alike can anticipate increasingly effective solutions for complex medical challenges.