17.09.2019

KNF Pumps Help Patients Survive the Wait for a Donor Heart

External ventricular assist devices

Almost 1,000 people are currently waiting for a donor heart in Germany alone. In extreme cases, patients rely on an external device for circulatory support to keep their heart working. Berlin Heart is the only supplier in the world to have developed a system which is approved even for newborns. It uses diaphragm gas pumps which are produced by KNF to stringent specifications.

Patients suffering from heart failure can temporarily rely on a ventricular assist device (VAD). The EXCOR® Pediatric system from Berlin Heart is the only one of its kind in the world. The mechanical blood pump is located outside the patient’s body and is connected to their heart and blood vessels via cannulae. It is the only VAD approved for children, toddlers and infants and has already saved more than 2,000 lives. EXCOR® consists of the blood pump, which takes over the work of the heart, and the stationary driving unit Ikus. Three KNF pumps work tirelessly inside the Ikus to keep the system running.

 

Image credits: Berlin Heart GmbH
Ikus Driving Unit by Berlin Heart
Image credits: Berlin Heart GmbH Ikus Driving Unit by Berlin Heart

The medical equipment manufacturer provided clear specifications for the development phase — the pumps had to be powerful, robust and low-maintenance. KNF’s diaphragm vacuum pumps check all of these boxes and also impressed the developers at Berlin Heart with their quiet, low-vibration operation. KNF’s development team worked with Berlin Heart to optimize the parameters of the series model N 023.1.2 using the pump manufacturer’s modular system, ultimately satisfying all of the customer’s requirements. Specially adapted ribbed plates and a particular silicone connection had to be utilized, among other considerations. And the pumps needed to meet stringent standards set not just by the manufacturer but also by the German TÜV and other, international certification authorities. Berlin Heart meticulously harmonized all of the components for its product EXCOR® Pediatric to obtain full market access in the US via FDA premarket approval (PMA).

 

The results in practice are just as impressive as the design. The KNF pumps work quietly and reliably around the clock, providing the pressure and vacuum which drive Berlin Heart’s blood pumps and allow them to simulate the heartbeat. The two active KNF pumps are supplemented by a third as a safety back-up. In extreme cases, this third pump could even take on the function of the other two for a limited period of time. The KNF pumps are housed in the Ikus stationary driving unit, which normally stands next to the patient’s bed.

 

EXCOR® and all of its components are designed for long-time operation due to the long waiting lists for donor organs. In a small number of cases, children supported with the external ventricular assist device recover so well that they no longer require a transplant at all.

The developers drew on KNF’s modular system to adapt the series model N 023.1.2 in line with the specific requirements of external ventricular assist devices.
The developers drew on KNF’s modular system to adapt the series model N 023.1.2 in line with the specific requirements of external ventricular assist devices.