LOBO™ Vascular Occlusion System

for Peripheral Vascular Occlusion

LOBO Technology

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.

HDbraid

POWERFUL HDBRAID TECHNOLOGY

  • 4x greater pore density and smaller pores than other braiding methods
  • Best-in-class pore structure significantly reduces flow to accelerate hemostasis and thrombosis
  • 5000+ pores for rapid and consistent occlusion with a single-device
  • Highly stable after placement
  • No spinnaker effect

Versatile Design

  • 3-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
LOBO3-in-Vessel

LOBO3 and Handle

Intuitive, User-Friendly Function

  • Low-profile 0.027” microcatheter compatible†
  • Occludes vessels as small as 1.5 mm†
  • Radiopaque marker bands for visualization
  • Fully retrievable prior to release
  • State-of-the-art, instantaneous mechanical detachment

† LOBO-3. Additional sizes in development

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 2,000-gauss/cm (20-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

LOBO methods of manufacturing are covered by U.S. Patent 9,994,980. LOBO products are covered by U.S. Patent 10,376,267. Other U.S. and foreign patent applications are pending.

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

2019© Okami Medical