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
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SOURCE Okami Medical Inc.