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LAVA®

LAVA® Liquid Embolic System
2 mL and 6 mL vial options available

The LAVA Liquid Embolic System (LES) is The First and Only Liquid Embolic Approved for Peripheral Vasculature Hemorrhage.

LAVA provides the confidence to quickly stop bleeds results in controlled target vessel occlusion.

LAVA is available in a 2 mL vial and a 6 mL vial; both vials have an 18 or 34 viscosity option. These pre-mixed vials allow for both a proximal target embolization and a distal target embolization, providing options to reach the bleed. The 2 mL LAVA LES comes with two (2) 1 mL delivery syringes and the 6 mL LAVA LES offers six (6) 1 mL delivery syringes, enabling you multi-zone embolization options from 1 pre-mixed vial. An optional Mixing Kit is available to expedite the shaking of the vial, which suspends the radiopaque particles. The volume of the particles in LAVA has been designed to reduce flash for clear imaging.

LAVA Presonlaized

xray1

References:
1. Based on clinical study on file (TPR-00913.01.A)
2. Yasumoto 2013, J Vasc Interv Radiol 2013;24:1798–1807
3. Based on data on file (TPR-01005.02.A)
4. Based on data on file: (TPR-00616.01.A and TPR-00499-02.A)
5. Data on file

Caution: U.S. federal law restricts the sale, distribution, and use of this product to physicians or as prescribed by a physician. This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures, and the physician would have successfully completed training. Indications for Use: LAVA® LES is indicated for embolization of arterial hemorrhage in the peripheral vasculature. Potential Complications: Potential adverse effects (e.g., complications) associated with the use of the device include: Non-target embolization, Ischemia or infarction of the target territory, Allergic reactions to device components, Catheter breakage, Catheter entrapment, Inadvertent embolization of a non-target vessel or territory, Embolization of device components, Access site hematoma or ecchymosis, Access site false aneurysm, Pain at access site, Arterial dissection, Mural thrombus formation, Vessel perforation, Hemorrhage, Recanalization, Vessel perforation, Arteriovenous fistula, Distal atheroembolism, Infection, Sepsis, Serous drainage, Lymphorrhea, Leg edema, Leg pain, and Back pain. Consult the Instructions for Use for a complete listing of indications, contraindications, potential complications, warnings, and precautions.