Aneurysm Embolization System for the Treatment of Cerebral Aneurysms. Information for Patients and Families

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1 this booklet is provided for for any non emergency questions, contact us at Aneurysm Embolization System for the Treatment of Cerebral Aneurysms Information for Patients and Families

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3 3 Information for patients and families This booklet aims to provide information about the WEB device and how it is used to treat brain (cerebral) aneurysms. It is intended for use by patients and their families in whom treatment with a WEB device has been proposed. If you have any questions about the WEB device, or would like further information about brain aneurysms, please do not hesitate to contact a member of the team caring for you. They will be happy to answer any question you may have. 1/ 2/ 3/ 4/ 5/ 6/ What is a brain aneurysm? 4 What are the different types of brain aneurysms? What are the treatment options for brain aneurysms? 5 What is the WEB device? 6 How can the WEB device help? 7 How should I prepare for the WEB device procedure? What happens during a WEB device procedure? 8 What should I expect after the WEB device procedure? 9 Emergency information

4 4 1/ What What is a brain aneurysm? are the different types of aneurysms? A brain aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. In some circumstances the brain aneurysm ruptures, releasing blood into the skull and causing a hemorrhagic stroke. Brain aneurysms are also called cerebral aneurysms. Aneurysm Saccular aneurysm Fusiform aneurysm Ruptured aneurysm Causes A person may inherit the tendency to form aneurysms, or aneurysms may develop because of hardening of the arteries and aging. Additional risk factors may include: family history, previous aneurysms, gender, race, high blood pressure, drug use and smoking. Symptoms Brain aneurysms can manifest in two different ways, un-ruptured and ruptured. Most un-ruptured brain aneurysms cause no symptoms and may only be discovered during tests for another, usually unrelated, condition. Sometimes, un-ruptured aneurysms will cause problems by pressing on nerves and other structures in the brain. This can cause a person to experience the following potential symptoms: headaches, blurred vision, changes in speech, difficulty moving, and neck pain. Ruptured brain aneurysms cause immediate, significant, and life threatening symptoms. In most circumstances, a ruptured aneurysm will cause a severe headache often described by patients as the worst headache of my life. This headache may be accompanied by other symptoms that may include blurred vision, changes in speech, difficulty moving, neck pain and loss of consciousness. A ruptured brain aneurysm is a life-threatening emergency that requires immediate medical attention. Saccular aneurysms Saccular aneurysms account for 80 % to 90 % of all brain aneurysms. Given their shape, these aneurysms are also known as berry aneurysms. They often form at the Y segment of arteries. Fusiform aneurysms Fusiform aneurysms are less common and look like an out-pouching of an arterial wall on both sides of the artery similar to a blood vessel that is expanded in all directions.

5 5 2/ What are the treatment options for brain aneurysms? As described below, there are several options available for the treatment of brain aneurysms. The location, size and shape of the aneurysm help determine which treatment is the safest and most effective. Your doctor or a member of their team will talk through all options with you. Surgical Clipping is a surgical procedure that requires the opening of the skull. A small metal clip is placed directly around the base of the aneurysm to isolate it from normal blood circulation. This relieves the pressure on the aneurysm and makes it less likely to rupture Coil Embolization is a minimally invasive procedure. To start, a small puncture is made in the groin to access the femoral artery. A small tube called a catheter is then inserted into the femoral artery. The catheter is then advanced through the main artery in the body and finally into the affected artery in the brain. Once there, the end of the catheter is carefully positioned inside the aneurysm. A series of tiny metal coils are then moved through the catheter and detached inside the aneurysm. These coils help slow and eventually stop blood flow into the aneurysm. This causes the aneurysm to heal and seal off. Sometimes tiny balloons and/or small mesh tubes called stents are used in conjunction with coils to help place the coils inside the aneurysm and to help the coils stay in place. Intraluminal Flow Diverter is a stent like device which is intended to divert flow away from the opening of an aneurysm. It is placed using a minimally invasive procedure much like that described for the coiling of an aneurysm. This allows for healing of the aneurysm.

6 6 3/ What is the WEB device? The WEB device is a tiny basket, made of very fine wire mesh. The WEB is placed into an aneurysm, reducing and eventually stopping the blood flow within it. Over time, the WEB device allows the aneurysm to heal and seal off. WEB DL WEB SL WEB SLS diameter 7 mm 5 mm 11 mm 4 mm 11 mm 4 mm 11 mm WEB DL is WEB SL is WEB SLS is available in available in available in 24 sizes with 26 sizes with 8 spherical sizes diameters diameters with diameters from 5 11 mm from 4 11 mm from 4 11 mm

7 7 4/ How How can the WEB device help? should I prepare for the WEB device procedure? The aim of the WEB device is to prevent blood from entering an aneurysm and therefore reduce the risk of it bleeding. It is designed to allow physicians to successfully treat large, wide necked aneurysms that may be difficult to treat with coils alone. Coil technology WEB technology Tell your physician about all medications you are taking prior to treatment to determine the best way to prepare. After you arrive at the hospital, the hospital staff will explain all the risks and benefits of your proposed treatment. If you are unsure about any aspect, do not hesitate to speak with a member of the staff again. Final preparations before the WEB procedure will include additional tests, special medicines, and preparation of the puncture site in your groin.

8 8 5/ What happens during a WEB device procedure? The procedure is performed by a physician trained in neurovascular procedures in a special operating room. Once the anesthetic has been delivered and you are comfortably asleep, the physician will make a small puncture in your groin to access the large artery there called the femoral artery. The physician will then use X-ray guidance to place a thin, flexible plastic tube called a catheter into the femoral artery. The catheter will be advanced through the femoral artery into the main artery in the body called the aorta and finally into one of the arteries supplying the brain. The catheter is then carefully advanced into the aneurysm. Finally, the WEB device is collapsed onto itself so it can be pushed through the catheter. As the WEB exits the end of the catheter it folds back into its original basket-like shape and is gently deployed into the aneurysm. Once deployed, the WEB immediately reduces and eventually stops the amount of blood getting into the aneurysm and begins the process of the aneurysm clotting off. The physician will verify the placement of the WEB using special X-rays. Once the physician is satisfied with the position of the WEB it is detached from its delivery system and the catheter is removed.

9 9 6/ What should I expect after the WEB device procedure? Emergency information Although the post treatment regimen can vary by hospital, generally after the procedure you will spend time in a special recovery unit before being transferred back to your room. This unit provides a high level of monitoring. You can expect to remain in the hospital after the procedure until you are walking and feeling normal. Your physician will monitor the treated aneurysm over time to ensure it is healing properly. Call your treating hospital /physician or emergency if any of the following occur: A post procedure head- Any neurological Drowsiness Severe neck stiffness ache that becomes very impairment including severe difficulty speaking, difficulty moving or visual disturbances

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11 11 Notes and questions Patient Information Card

12 LB0043 EN Rev A The WEB Aneurysm Embolization System and VIA Microcatheter have both received the CE mark. They are not approved for or available for sale or use in the United States. Sequent Medical Inc. 11 Columbia Aliso Viejo, CA Office: +1 (949) Fax: +1 (949) Sequent Medical Europe GmbH An der Marienkapelle Bonn / Germany Office: Fax: europe@sequentmedical.com