Managing Ascites Information for patients and caregivers about ascites and a new treatment option, the alfapump® system.

Information for Patients

Refractory ascites Ascites is a chronic condition which causes excess fluid to collect in the abdominal cavity. Ascites has various causes, and is most commonly associated with advanced liver disease and certain cancers. When ascites cannot be controlled with a special diet or medication, it is described as being ‘refractory’ to medical therapy. The accumulation of ascites poses a medical risk to patients, and its symptoms can be debilitating. • As more and more fluid accumulates, the abdomen becomes swollen and hard, making even minor everyday tasks difficult to perform. • The ascites presses against internal organs, which can lead to a loss of appetite and fatigue.

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Although the problem of refractory ascites has long been recognised, researchers have struggled to find a way of managing the condition in a way that is both natural and comfortable for patients. The most common treatment for refractory ascites is paracentesis, an invasive procedure which has been used for hundreds of years. Paracentesis involves the insertion of a large-bore needle into the abdomen through the abdominal wall. The excess fluid is then drained over a period of a few hours. Patients with severe ascites sometimes need to undergo this invasive procedure once or more per week in order to have many litres of ascites drained. For these patients, this in-hospital procedure cannot be avoided, and negatively impacts their quality of life.

Making life easier Patients suffering from refractory ascites have repeatedly expressed the same wishes to clinicians, who up until now have not been able to provide a solution: • Is it possible to eliminate the ascites as soon as it forms, therefore preventing my abdomen from swelling up? • Is there a treatment available that allows me to avoid repeated hospital visits for drainage procedures? In advanced liver disease, the build-up of ascites may be prevented by a salt-restricted diet and the use of diuretics. However, these measures become less effective over time, and eventually stop working, or the required dosage is so high that life-threatening side effects prevent their use.

In patients with ascites caused by cancer, a salt-restricted diet and the use of diuretics are not effective in managing ascites. The use of chemotherapy drugs delivered directly into the abdominal cavity can stop the accumulation of ascites, but this relief is temporary and the ascites inevitably reappears. For Sequana Medical, the company who developed the alfapump system, it was not an option to leave these patients without an advanced treatment to manage their ascites safely, naturally and on a continual basis.

This booklet provides more information on how the alfapump system can help patients to avoid the complications caused by the build-up of ascites, and help them achieve a more free and independent lifestyle.

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alfapump® Automated ascites management, naturally We developed the alfapump system to help patients suffering with refractory ascites avoid abdominal swelling and its accompanying complications. The alfapump is a fully implantable battery-operated pump for the management of ascites. • The alfapump moves ascites to the bladder, where it is excreted naturally from the body. • The alfapump works automatically, removing ascites naturally as it forms. • The alfapump is implanted using minimally invasive surgery. This simple procedure usually takes between 30 and 60 minutes.

This means • Ascites no longer collects in the abdominal cavity in most patients, thereby eliminating abdominal swelling. • Paracentesis can be significantly reduced or eliminated entirely, because the ascites is excreted naturally from the body via the bladder. • Your doctor can program the pump to meet your individual requirements and set it in accordance with your daily routine, for example to adapt to your work or sleeping pattern. Many doctors and patients have reported that the alfapump system helps improve quality of life, and is a small step towards a more normal lifestyle. Which we consider a giant leap forward.

Peritoneal (abdominal) cavity Ascites Peritoneal catheter Bladder catheter

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Components The extensive research and development that went into the alfapump is reflected in the sophisticated workings of the pump mechanics and controls. The alfapump is programmed,

charged and monitored wirelessly. While you are reading or watching television, simply place the smart charger (the intelligent charging device) over the alfapump to charge it.

alfapump®

The alfapump is implanted under the skin and pumps up to 4 litres of ascites per full battery charge. It also monitors pressure in the bladder and abdominal cavity to ensure optimal fluid management.

Smart Charger

The smart charger is used to charge the alfapump. During charging, data from the pump is uploaded to the smart charger which can be downloaded and evaluated by your doctor during hospital visits.

Catheters

Standard implantable grade silicone catheters are utilized to collect ascites from the abdominal cavity and deliver it to the bladder. These catheters are are implanted completely inside the body and are not visible from the outside.

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Who, how, when, where? Accessing further information about the alfapump® system The alfapump system has been greeted with a great deal of interest and excitement by doctors and patients, and is being adopted by an increasing number of hospitals. The first patient with refractory ascites received an alfapump in 2009, and many more have since been able to benefit from this innovative technology.

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On our website www.alfapump.com you can find important information material and interesting video and radio reports. Visit the website to find out more about the alfapump system.

alfapump® A technology for experts The alfapump system is a state-of-the-art technology to help patients suffering from serious medical conditions such as cancer or advanced liver disease. This means that the decision to use the alfapump system is highly individual to each patient and his or her situation. Once you have acquainted yourself with the alfapump system, talk to your doctor. Only he or she can decide whether the

alfapump is suitable for you and your circumstances. We also have a wide range of information material available for healthcare professionals, including clinical studies and case reports. If you and your doctor decide that the alfapump system is right for you, we will help you to find a hospital centre close to you, where you and your relatives will receive expert advice and care.

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For more information visit www.alfapump.com

@ Sequana Medical or its affiliates. All rights reserved. The alfapump system is indicated for the management of refractory and recurrent ascites due to liver cirrhosis as well as the management of malignant ascites for palliative use. Please contact your physician for indication, contra-indication and side effects.

Sequana Medical AG Technoparkstrasse 1 8005 Zurich Switzerland

Phone: +41 44 403 55 00 Fax: +41 44 403 55 09 www.sequanamedical.com

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Sequana Medical is a Swiss medical device company dedicated to improving patient lives by providing innovative solutions to manage fluid balance within the body.