Demonstration of the potential application of Agluna anti-infective surface treatment technology to cardiac pacemakers

展示Agluna抗感染表面处理技术在心脏起搏器上的潜在应用

• 批准号: 710148
• 金额: $ 9.59万
• 依托单位: ACCENTUS MEDICAL LIMITED
• 依托单位国家: 英国
• 项目类别: GRD Proof of Concept
• 财政年份: 2012
• 资助国家: 英国
• 起止时间: 2012 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=710148
• 关键词: Demonstration; potential; application; Agluna; anti

The Agluna® process, a cost effective method of introducing silver ions into the surface oftitanium implantable medical devices, has been pioneered for custom implants for bonecancer patients since March 2006. 375 clinical implantations of such Agluna® devices havetaken place over the past 5 ½ years, with a significant reduction in the incidence and severityof post-operative infection in device surgery compared with using untreated implants or anyother preventative approach to controlling infection. The technology is now being activelycommercialised within the field of mainstream titanium orthopaedic devices.The objective of the proposed study is to determine the technical feasibility of applyingAgluna® to the titanium casing of a cardiac pacemaker, as a potential breakthroughtechnology in preventing post-operative infection in cardiac surgery. There are three principalobjectives of the study:- To demonstrate the feasibility of applying Agluna® (a high voltage anodising process) to afully assembled cardiac pacemaker device without detriment to the basic functionality of thepacemaker.- To determine if Agluna® treated titanium surfaces used for cardiac device casings reduce theclinical effectiveness of the cardiac device and/or alter soft tissue biocompatibility comparedwith non-Agluna® treated devices.- To define requirements of a future clinical research study intended to demonstrate the safetyand efficacy of an Agluna®-treated cardiac device.The available market for Agluna® in the pacemaker field is substantial. Cardiac deviceimplantation rates are accelerating as the result of 1. broadening in the range of indications forwhich these devices are being deployed, and 2. globally ageing population. Infectionassociated with pacemaker devices is a serious and costly complication, necessitating removalof the device and prolonged antibiotic therapy. Mortality is reported to occur in up to 20% ofpatients suffering a cardiac pacemaker infection.

Agluna®工艺是一种将银离子引入钛植入式医疗器械表面的经济有效的方法，自2006年3月以来，该工艺已率先用于骨癌患者的定制植入物。在过去的5年半时间里，此类Agluna®器械已进行了375例临床验证，与使用未经处理的植入物或任何其他预防性感染控制方法相比，器械手术中术后感染的发生率和严重程度显著降低。该技术目前正在主流钛骨科器械领域积极商业化，本研究的目的是确定将Agluna ®应用于心脏起搏器钛外壳的技术可行性，作为预防心脏手术术后感染的潜在突破性技术。本研究有三个主要目的：-证明将Agluna®（一种高压阳极氧化工艺）应用于完全组装的心脏起搏器设备的可行性，而不会损害起搏器的基本功能。-确定用于心脏器械外壳的经Agluna®处理的钛表面与未经Agluna ®处理的器械相比是否会降低心脏器械的临床有效性和/或改变软组织生物相容性。旨在确定未来临床研究的要求，该研究旨在证明经Agluna®处理的心脏器械的安全性和有效性。Agluna®在起搏器领域的可用市场是巨大的。心脏装置植入率正在加速，由于1。扩大这些器械部署的适应症范围，以及2.全球人口老龄化。与起搏器装置相关的起搏是一种严重且昂贵的并发症，需要移除装置并延长抗生素治疗。据报道，心脏起搏器感染患者的死亡率高达20%。