Technological advances in Sequana Medical’s alfapump system will allow patients and their doctors to better manage the distressing symptoms of refractory ascites, a condition in which fluid builds up in the patient’s abdomen as a result of late-stage liver disease or cancer. With enhanced communications enabled by the new DirectLink Technology, clinicians will now be able to monitor the alfapump remotely.

Patients with late stage liver disease or cancer require intensive treatment. Management of key symptoms such as ascites is critically important for patients, many of whom are waiting for a liver transplant. The build-up of ascitic fluid in their abdomens can be painful, preventing them from eating well or exercising and often causing painful hernias.

Sequana Medical, a Swiss-based medical devices company, has pioneered the alfapump, the first and only internal pump system providing automatic and continual removal of ascites, now with DirectLink technology to improve patient management.

Prior to the alfapump, the only therapy available for most patients with refractory ascites was large volume paracentesis, a lengthy, invasive procedure which can require weekly visits to the hospital for removal of the many litres of fluid from the abdomen. The process can be distressing for patients as it involves the use of large bore needles, sometimes inserted many times to access and remove the ascites.

Michael Beckett, 50, from Portsmouth, UK had serious liver problems. He explains, “Before I had my alfapump implanted I had a huge belly with tiny arms and legs. I wasn’t eating and I was tired all of the time. I had to go to the Queen Alexandra Hospital in Portsmouth to have the fluid drained – sometimes I had 14 litres, that’s 14 kilos of extra weight around my belly.”

Michael is now remarkably fit and his liver function is back to normal thanks to the care of his physicians and the alfapump therapy which allowed him to eat well and exercise.

Michael believes the new alfapump system will make a big difference for people who are in the situation he was in two years ago. He had to travel a long distance to the Royal Free Hospital in London for his specialist liver care and he thinks that the new DirectLink upgrades will reduce the need for travel and hospital visits. He welcomes the added reassurance that the new developments offer patients, “Early proactive notice of any pump changes has got to be good news.”

Dr Anne McCune, consultant hepatologist in the department of Medicine and Surgery at University Hospitals Bristol, leads the clinical trial team participating in a randomised controlled trial investigating alfapump technology vs. regular paracentesis in patients with liver cirrhosis and refractory large volume ascites.

Dr McCune explains, “When patients have cirrhosis, the liver and kidneys stop working properly and patients can accumulate litres and litres of fluid in their abdomens which can be very painful. They might need to come to hospital fortnightly to have up to 15 litres drained from their tummy. The alfapump can avoid this by draining about 15 millilitres every 15 minutes. It means they'll pass a little bit more urine but we can program the pump to switch off at night for comfort. The new DirectLink Technology, which allows the alfapump to be monitored remotely, will ensure that the programmed therapy has been accurately delivered. The pump has the potential to improve quality of life for our liver patients and keep them out of hospital for longer periods. The study is ongoing and will evaluate both the clinical and cost-effectiveness of this exciting device.”

Noel Johnson, the CEO of Sequana Medical explains, “We are very pleased with the improvement in clinical outcomes and patient quality of life seen with the alfapump therapy as ascites patients live free from repeat large volume paracentesis, avoiding the risk of current therapeutic options. Now with the remote monitoring enabled by the DirectLink Technology we expect to see increased efficiencies for healthcare professionals and an increased feeling of security for the patient.”

The full launch of the new alfapump system will take place in December 2014 to the main European markets (Germany, Austria, Switzerland, France, UK, Denmark, Sweden, Norway), expanding to other countries in 2015 with some restrictions regarding the SIM card activation.