OKAMI MEDICAL ANNOUNCES FDA 510(k) CLEARANCE OF THE LOBO-7 and LOBO-9 VASCULAR OCCLUDERS TO ADDRESS A WIDE RANGE OF PERIPHERAL EMBOLIZATION CASES

Rhea-AI Summary

Okami Medical Inc. has received FDA 510(k) clearance for its LOBO-7 and LOBO-9 Vascular Occluders, enhancing its LOBO portfolio designed for peripheral vascular interventions. These new devices, along with existing LOBO-3 and LOBO-5, enable efficient blood vessel occlusions, crucial for procedures requiring rapid response in trauma cases. According to the company's leadership, this expansion emphasizes their commitment to innovation in vascular embolization, potentially improving patient outcomes and procedural efficiency.

Positive

• FDA clearance obtained for LOBO-7 and LOBO-9, expanding product portfolio.
• LOBO system aims to improve procedural efficiency and patient outcomes.
• Devices designed for quick and complete occlusion, addressing critical clinical needs.

Negative

• None.

ALISO VIEJO, Calif., June 7, 2022 /PRNewswire/ -- Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company's LOBO^® Vascular Occlusion System. 

The LOBO (LOw-profile Braided Occluder) system, purpose-built for fast and complete occlusion of a diverse set of peripheral arterial targets, now includes LOBO-3, LOBO-5, LOBO-7 and LOBO-9. The LOBO occluders integrate patented HDBRAID^® technology and an innovative design to provide interventional physicians with a One-and-Done solution for embolization. The highly occlusive braided structure rapidly reduces flow and enables single-device occlusions of blood vessels throughout the body. LOBO-7 and LOBO-9 are intended for use in 5 to 7 mm and 7 to 9 mm diameter vessels, respectively. LOBO-3 and LOBO-5, both previously FDA cleared, are intended for use in 1.5 to 3 mm and 3 to 5 mm diameter vessels, respectively. 

"LOBO represents the next evolution in vascular embolization. As opposed to coils, which rely on the formation of an irregular mass with relatively large voids to try to occlude vessels, LOBO utilizes a high density, uniform small pore structure to occlude vessels nearly instantly," said Raj Pyne, MD, FSIR, interventional radiologist at Rochester Regional Health. "The ability to occlude vessels quickly and consistently with a single-device not only improves procedure efficiency, but also is critical and often life-saving in situations such as trauma and unstable bleeding.  The smaller occluders, LOBO-3 and LOBO-5, have demonstrated excellent performance and I am excited to see the larger sizes in use."

"The FDA clearance of LOBO-7 and LOBO-9 is a testament to Okami Medical's commitment to provide patients and physicians with access to advanced technologies that address the numerous challenges in peripheral vascular occlusion," said Bob Rosenbluth, PhD, President and CEO of Okami Medical. "The LOBO system now includes a portfolio of devices that is specifically designed and built to quickly and completely occlude a wide range of vascular targets, thus eliminating the need for multiple embolic devices and enabling more efficient interventions."

About Okami Medical, Inc.

Okami Medical, Inc. is a privately-held medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention. Okami is the second portfolio company of Inceptus Medical LLC, a medical device incubator. Inari Medical, Inc. (NASDAQ: NARI), Inceptus' first portfolio company, is pioneering approaches to treat pulmonary embolism and venous clotting.  Okami is backed by members of the board of directors, U.S. Venture Partners (www.usvp.com) and medical device industry veterans. For more information, please visit www.okamimedical.com.

Source:
Okami Medical, Inc.
949-446-9710
info@okamimedical.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/okami-medical-announces-fda-510k-clearance-of-the-lobo-7-and-lobo-9-vascular-occluders-to-address-a-wide-range-of-peripheral-embolization-cases-301562621.html

SOURCE Okami Medical Inc.

FAQ

What is the significance of the FDA clearance for LOBO-7 and LOBO-9?

The FDA clearance allows Okami Medical to offer advanced vascular occluders, enhancing treatment options in peripheral vascular interventions.

What conditions do LOBO-7 and LOBO-9 address?

These devices are intended for use in occluding 5 to 9 mm diameter blood vessels, crucial for various medical emergencies.

How does the LOBO system differ from traditional embolization methods?

The LOBO system uses a high-density, uniform small pore structure for rapid occlusion, unlike traditional coils that rely on irregular masses.

What company is associated with the ticker NARI in this press release?

Inari Medical, Inc. is linked to NARI and is a portfolio company of Inceptus Medical, which also includes Okami Medical.

What does the LOBO system mean for interventional procedures?

The LOBO system's design allows physicians to achieve vascular occlusion quickly, improving efficiency and potentially saving lives in urgent cases.