FDA Expands Okami’s LOBO Occluder to Peripheral Veins

FDA has cleared an expanded indication for Okami Medical's LOBO Vascular Occlusion System, extending a device first cleared for peripheral arterial embolization in 2019 into peripheral venous use as well. Okami announced the clearance on 7 October 2026. The company frames the addition around conditions such as pelvic venous disease and portal-hypertension-related venous bleeding — uses where physicians were in some cases already applying an arterial-cleared device off-label, and where FDA's decision now gives that use a label to match.

An old device, a new label line

LOBO's original clearance, granted in 2019, covers obstructing or reducing blood flow in arteries of the peripheral vasculature, and explicitly excludes vessels where crush or bend forces are expected — language aimed at joints and superficial vasculature. The device has since grown into a four-size family (LOBO-3, LOBO-5, LOBO-7, LOBO-9) built on what Okami calls HDBraid construction: wires under 20 microns in diameter braided into a denser pore structure than conventional occluders, which the company says reduces the streak artifact that can obscure follow-up CT imaging after embolization. That same construction is the basis Okami cites for the venous expansion. Two named physicians, Raj Pyne, MD, of Rochester Regional Health and Harris Chengazi, MD, of Great Lakes Medical Imaging, are quoted in the announcement describing the venous indication as a natural extension of the device's existing design, easing procedures that previously required multiple devices or contended with imaging artifact.

What RA/QA teams should take from an indication expansion

A label expansion is a lower bar than a new 510(k) for a first-time device, but it is not a formality: FDA still has to agree the existing design, materials and performance data support the new intended use, here extending from a higher-pressure arterial environment into the venous system, where flow dynamics, vessel fragility and clinical risk profiles differ. For a submission strategy, it illustrates a well-worn device-expansion path — grow a cleared platform's label one use case at a time, on the strength of the original engineering, rather than opening an entirely new review. For clinicians and purchasing teams, the clearance converts what some centers may already have been doing off-label in venous procedures into an on-label use, with the attendant shift in liability and reimbursement footing that an on-label indication carries. Okami's own announcement does not publish new venous outcome data to accompany the clearance decision, which is worth noting for anyone evaluating the device for the newly labeled use rather than assuming the arterial track record transfers automatically.

Frequently asked questions

What did FDA clear for Okami Medical?

An expanded indication for the LOBO Vascular Occlusion System extending its intended use from peripheral arterial embolization into peripheral venous embolization, including pelvic venous disease and portal-hypertension-related venous bleeding.

Is this a new device?

No. LOBO has been 510(k)-cleared and marketed since November 2019, with additional sizes cleared in later submissions. This is a label expansion, not a new product clearance.

What is Okami's evidence for the venous use?

The announcement cites the device's existing HDBraid construction and physician commentary rather than publishing new venous-specific clinical outcome data.

Who is Okami Medical?

A privately held, California-based device company founded in 2017 by medical device incubator Inceptus Medical, which also founded Inari Medical, Sequent Medical and MicroVention.