Aims: Sacral neuromodulation (SNM) is a guideline‐recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration‐approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN‐SNM study was designed to evaluate UUI participants treated with the Axonics System. Two‐year follow‐up results are presented.Methods: One hundred and twenty‐nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3‐day voiding diaries, ICIQ‐OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post‐treatment. As‐treated and Completers analyses are presented.Results: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ‐OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device‐related adverse events occurred.Conclusions: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant‐related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.
18 March 2010 in The International Journal of Advanced Manufacturing Technology
Purpose – The purpose of this paper is to report on the use of a combination of indirect selective laser sintering (SLS) and machining processes to create injection mould tools, an approach designed to offer the capability to create conformal cooling channels in the core/cavity inserts together with the levels of surface finish and accuracy required to meet typical injection mould tool specifications. Design/methodology/approach – The research has been pursued through three industrial case studies. In each study, existing injection mold inserts have been redesigned to give a conformally cooled tool. These have then been manufactured using indirect SLS, high-speed machining, electro-discharge machining and polishing. The inserts have been evaluated in industrial trials to assess their performance in terms of cycle time, energy usage, durability and quality. The insights gained from the three case studies have then been developed into a series of design rules, which may be applied in the development of tooling for new applications. Findings – The results show that significant productivity improvements and energy use reductions in injection moulding are possible through the implementation of conformal cooling, and that the material has sufficient wear resistance to be used in production applications. However, it is recommended that modelling is always used to understand the impact of conformal cooling channels, and manufacture is carefully planned to ensure that the required internal geometry is created. Originality/value – The paper presents new results on the impact of conformal cooling on the productivity and energy efficiency of injection moulding, and on the durability of the indirect SLS material in injection moulding applications. A novel “cut-out volume” technique for powder clearing is also presented, along with a set of design rules to support further application of the work.