Baxter International (Deerfield, IL) received regulatory approval to bring its VIVIA hemodialysis system to the European market. The device is designed for more comprehensive High Dose hemodialysis which can be performed during short daily sessions or at night while sleeping.
The touchscreen interface was developed for patient use, since the system is intended to stay in the patient’s home, and instructions on the screen include graphical illustrations on how to setup the device, perform treatment, and clean it once done. To help guarantee safety, the VIVIA features a sensor that detects if a needle is dislodged and sends a signal for the machine to stop pumping.
Additionally, as with many at-home medical devices coming to market, the VIVIA features wireless connectivity to share its hemodialysis regimen data with the patient’s physician.
More from the announcement:
Baxter will introduce VIVIA in a limited number of European dialysis clinics in 2014 to allow patients and healthcare providers to become familiar with the system and its patient-friendly features. Baxter plans to expand the launch to other European countries in 2015.
Data from clinical trials conducted in the United States and Canada evaluating the safety and effectiveness of VIVIA in more than 1,000 treatments were submitted as part of the filing for CE marking1,3. CE mark is a regulatory requirement for medical devices to be sold in the European Union.