NEW IMPLANTATION TOOL, STEERABLE STYLET CLINICAL-ASSESSMENT STUDY

The LOCATOR(TM) Steerable Stylet model 4036 is a new stylet that allow s the physician to manipulate the shape from straight to various curve s of the distal portion without removing it from the endocardial pacem aker lead during implantation. A one-hand control mechanism is attache d to a twin guide wire, which allows various shapes of the stylet and thereby also the lead. The evaluation of the Steerable Stylet was a su bjective comparison to traditional technique regarding six factors: ve nous passage, positioning-mapping, lead fixation-stylet retraction, im plantation time, X-ray time and overall clinical performance. The visu al scale used was: poor -> neutral -> excellent, poor (-10) being wors e than traditional technique, neutral (0) being equivalent to traditio nal technique and excellent (+10) being superior to traditional techni que. This study includes 75 devices. The results from this study show that a majority of the assessed devices received positive assessments. For the five factors: mapping-positioning, lead fixation-stylet retra ction, implantation time, X-ray time and overall clinical performance, the assessments were above neutral, or indicated time reduction, in 7 1-79%. Only one factor venous advancement shows a lower positive asses sment rate of 50% positive and 46% neutral assessments. The results of this study show that the LOCATOR(TM) Steerable Stylet offers valuable benefits and major improvements, compared to current techniques, for the physician in the transvenous implantation of endocardial pacemaker leads.