An Option for the Treatment of Brain Aneurysms

LVISTM

Intraluminal Support Device

Low-profile Visualized Intraluminal Support

What is a brain aneurysm? A brain aneurysm is a bulge or sac that develops in a bloodvessel of the brain called an artery.• As the aneurysm grows, the vessel wall continues to thin and weaken.

This may cause symptoms such as headache, nausea, vomiting, andvision problems.

• The vessel wall can become so thin that it leaks or ruptures,releasing blood into the space around the brain, which is a lifethreatening problem.

• Depending on the severity of thebleed, potential consequencesinclude:

– Functional disability– Cognitive impairment– Loss of life

LVISIntraluminal Support Device

What are the types of aneurysms?Aneurysms can be classified by size and shape.

Size

SMALL Up to 10 mm

LARGE 10 - 25 mm

GIANT Larger than 25 mm

10 mm 25 mm

Actual Size

Saccular Aneurysm

Wide-neck Aneurysm Ruptured Aneurysm

Fusiform Aneurysm

What are the treatment options?Surgical ClippingA surgical procedure involving opening of the skull.

• A clothespin-like metal clip is then placed across the neck of theaneurysm to prevent blood flow into the aneurysm.

Parent Artery Occlusion• Blood flow to the artery feeding the aneurysm is blocked using

one of multiple different methods.

Endovascular Treatment• Treatment using a minimally invasive approach accessing the

aneurysm through the blood vessels in the leg.

• Aneurysm treatment is performed using embolic coils with orwithout stents, or flow diverters. Each of these methods have theirown advantages and drawbacks.

• These treatments prevent blood from flowing into the aneurysm andcause the aneurysm to occlude over time.

Surgical clipping Coiling

Stent-Assist Coiling

The doctor will then deploy the LVIS

device across the neck of the aneurysm.

Once the LVIS device is deployed, the doctor will deliver coils into the aneurysm.

The coils, in conjunction with the LVIS device, prevent blood from flowing into the aneurysm and allow the aneurysm to occlude.

The LVIS Intraluminal Support DeviceThe LVIS Intraluminal Support Device is a novel stent designed for stent-assisted coiling.

• Stent-assisted coiling is typically performed in saccular wide- necked aneurysms to help keep coils in the aneurysm.

• The LVIS device has been used to treat patients globally since2012.

The Procedure

During the procedure, the doctor will access the aneurysm from an artery in the leg using a small diameter microcatheter.

AccessPoint

Aneurysm

MicrocatheterPath

What should I expect before, during, and after my procedure?Before the ProcedureYour doctor will perform a series of exams and diagnostic procedures to determine the size, type, and location of your aneurysm, as well as assess treatment options for your aneurysm. Some of the exams may include:

– Lifestyle and medical history review– Physical Examination– Neurological examination– Blood tests– Diagnostic imaging (CT-Scan, MRI)– Cerebral Angiogram

Your doctor may require you to prepare for the procedure by taking certain medications:

• A few days before the procedure, you may be asked to takeantiplatelet medications such as aspirin.

• Additional medications may be prescribed by your doctor.

During the Procedure• Your procedure may be performed under either local or general

anesthesia, though general anesthesia is typically preferred since you must remain still for a long period of time.

• Stent assisted coiling using the LVIS deviceinvolves accessing the aneurysm, placingthe LVIS device across the aneurysm,and coiling the aneurysm. The durationof the entire procedure varies,but typically takes between1-3 hours.

After the Procedure• You will be moved into a recovery room after the procedure

is completed.

• You will likely experience some pain and discomfort in your thigh / groin where the catheters were inserted into your artery.

• You will be required to continue taking antiplatelet medications such as aspirin following the procedure. Your doctor will explain your medications to you.

• Your doctor will provide you with an MRI card that explains how the LVIS device will behave under various medical scans.

Potential Risks*• Persons with known allergy to nickel or other metals may suffer an

allergic reaction to the LVIS Device

• Potential bleeding risks associated with antiplatelet medications

• Rupture and bleeding of the aneurysm or blood vessel

• Aneurysm recurrence

• Headache

• Death

*Discuss all risks with your doctor

Glossary

Embolic coil – An implantable medical device that looks like a slinky which helps facilitate clot formation within an aneurysm, thus preventing blood from entering the aneurysm.

Microcatheter – A small diameter, thin tube that travels through the blood vessels to the desired area. Once reaching the desired location, the microcatheter can be used to deliver therapeutic agents.

Stent – A tubular support structure placed into a blood vessel to help keep coils in the aneurysm and aid in healing.

Occlude – To block the neck of an aneurysm to prevent blood from flowing into the aneurysm.

MICROVENTION and LVIS are registered trademarks of MicroVention, Inc. in the United States and other jurisdictions.• Refer to Instructions for Use, contraindications and warnings for additional information. ©2018 MicroVention, Inc. MM493 Rev. B 02/21

MicroVention Worldwide Innovation Center 1.714.247.8000 35 Enterprise Aliso Viejo, CA 92626 USACustomer Service 1.800.990.8368Web microvention.com

RX ONLY: Federal (USA) law restricts this device to sale by or on the order of a physician. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate fluoroscopy equipment. The LVIS® device should only be used by physicians who have received appropriate training for the device.

INDICATIONS FOR USE: The LVISTM and LVISTM Jr. devices are indicated for use with neurovascular embolization coils in patients ≥ 18 years of age for the treatment of wide-neck (neck width ≥ 4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm. CONTRAINDICATIONS: Use of the LVIS device is contraindicated under these circumstances: Patients in whom anticoagulant, anti-platelet therapy or thrombolytic drugs are contraindicated; Patients with known hypersensitivity to metal, such as nickel-titanium and metal jewelry; Patients with anatomy that does not permit passage or deployment of the LVIS device; Patients with an active bacterial infection; Patients with a pre-existing stent in place at the target aneurysm. POTENTIAL ADVERSE EVENTS: The following potential risks and complications associated with general anesthesia, cerebral angiography, intracranial catheterization, intracranial stent placement or intra-saccular coil deployment have been identified: A llergic r eaction, i ncluding b ut n ot l imited t o: c ontrast d ye, n itinol metal, and any other medications used during the procedure; Aphasia; Blindness; Cardiac Arrhythmia; Coil prolapsed or migration into normal vessel adjacent to aneurysm; Complications of arterial puncture including pain, local bleeding, local infection and injury to the artery, vein or adjacent nerves; Cranial neuropathy; Death; Device fracture, migration or misplacement; Dissection or perforation of the parent artery; Headache; Hemorrhage (i.e., intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or retroperitoneal (or in other locations)); Hemiplegia; Hydrocephalus; Infection; Injury to normal vessel or tissue; Ischemia; Mass effect; Myocardial Infarction; Neurological deficits; Occlusion of non-target side branches; Pseudo aneurysm formation; Reactions to anti-platelet/anti-coagulant agents; Reactions due to radiation exposure; Reactions to anesthesia and related procedures; Reactions to contrast agents; Renal failure; Aneurysm rupture; Stenosis of stented segment; Seizure; Stent thrombosis; Stroke or TIA (Transient Ischemic Attack); Thromboembolic event (T/E); Vasospasm; Visual impairment. Potential Risks Associated with X-ray Exposure: The use of the LVIS device requires fluoroscopy, which presents potential risks associated with X-ray exposure. The risks of angiographic and fluoroscopic X-ray radiation doses to the patient include risks such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase. The probability of adverse event occurrence increases as the procedure time and the number of procedures increase. Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.

Results may vary. Not all patients receive the same results. Talk to your doctor about all risks.

LVISIntraluminal Support Device