The Agluna® process, a cost effective method of introducing silver ions into the surface of
titanium implantable medical devices, has been pioneered for custom implants for bone
cancer patients since March 2006. 375 clinical implantations of such Agluna® devices have
taken place over the past 5 ½ years, with a significant reduction in the incidence and severity
of post-operative infection in device surgery compared with using untreated implants or any
other preventative approach to controlling infection. The technology is now being actively
commercialised within the field of mainstream titanium orthopaedic devices.
The objective of the proposed study is to determine the technical feasibility of applying
Agluna® to the titanium casing of a cardiac pacemaker, as a potential breakthrough
technology in preventing post-operative infection in cardiac surgery. There are three principal
objectives of the study:
- To demonstrate the feasibility of applying Agluna® (a high voltage anodising process) to a
fully assembled cardiac pacemaker device without detriment to the basic functionality of the
pacemaker.
- To determine if Agluna® treated titanium surfaces used for cardiac device casings reduce the
clinical effectiveness of the cardiac device and/or alter soft tissue biocompatibility compared
with non-Agluna® treated devices.
- To define requirements of a future clinical research study intended to demonstrate the safety
and efficacy of an Agluna®-treated cardiac device.
The available market for Agluna® in the pacemaker field is substantial. Cardiac device
implantation rates are accelerating as the result of 1. broadening in the range of indications for
which these devices are being deployed, and 2. globally ageing population. Infection
associated with pacemaker devices is a serious and costly complication, necessitating removal
of the device and prolonged antibiotic therapy. Mortality is reported to occur in up to 20% of
patients suffering a cardiac pacemaker infection.