LOBO Technology

LOBO® Vascular Occlusion System

for Peripheral Vascular Occlusion

The LOBO occluder is the first and only peripheral embolization device featuring proprietary HDBRAID® technology – an innovative, unique braiding method developed specifically for making devices to occlude vessels. With this method, braided devices can be made with wires less than 20 microns in diameter – about ¼ the thickness of a human hair.

Most vascular occluders rely on either a braided structure – one with relatively large wires and pores – or a polymer cover to disrupt flow. These approaches can lead to inconsistent occlusion or migration.

LOBO addresses these challenges by integrating HDBRAID technology and a patented design. The result is a device with a best-in-class pore structure that delivers rapid and consistent occlusion of a wide range of arteries.

POWERFUL HDBRAID TECHNOLOGY

High density, small pore structure for optimal flow obstruction
Significantly reduces flow to accelerate hemostasis and thrombosis
Fast and complete occlusion with a single device
Highly stable after placement
No spinnaker effect

Versatile Design

Multiple-disc design to compound the occlusive effects of the HDBRAID technology
Excellent trackability to small, tortuous vessels
Focal and efficient occlusion
Expands accessible anatomical locations
Conformance to curved vessels

Intuitive, User-Friendly Function

Microcatheter compatible†
Occludes a wide range of peripheral vessels
Radiopaque marker bands for visualization
Fully retrievable prior to release
State-of-the-art, instantaneous mechanical detachment

† LOBO-3 and LOBO-5

See Instructions for Use for a complete list of warnings, precautions, and contraindications

Indications for Use

The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).

Rx Only: Federal (USA) law restricts device to sale by or on the order of a physician.

MRI Safety Information

Non-clinical testing and MRI simulations were performed to evaluate the LOBO Vascular Occlusion Device. Non-clinical testing demonstrated that this product is MR Conditional. A patient with an implant can be scanned safely in an MR system under the following conditions:

Static magnetic field of 1.5-Tesla and 3-Tesla, only
Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg in the Normal Operating Mode

Under the scan conditions defined, an implant from the LOBO Vascular Occlusion Device is expected to produce a maximum temperature rise of 2˚C after 15-minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the implant from the LOBO Vascular Occlusion Device extends approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a 3-Tesla MR system.

Okami Medical Intellectual Property

The product(s) listed on this website, either alone or in combination with other product(s), may be protected by one or more of the identified U.S. patents. Each product may also be protected by one or more patents issued outside of the U.S., and additional patent applications related to one or more of the listed products may be pending in the U.S. or elsewhere. The absence of a product name or patent number associated with any listed product does not constitute a waiver of Okami Medical’s intellectual property rights concerning that product or patent. This website is intended to serve as notice under 35 U.S.C. § 287(a).

LOBO – U.S. Patents 10,376,267, 10,660,648 and 11,304,701.

LOBO Manufacturing – U.S. Patents 9,994,980, 10,577,733, 11,346,027, 11,885,051 and 11,898,282.

LOBO Delivery System – U.S. Patents 10,531,877 and 11,298,137.

Okami Medical and LOBO are trademarks of Okami Medical, Inc. HDBRAID is a trademark of Inceptus Medical LLC.