One specialist commentator noted that the consistent message from general published evidence is that contact force‑guided ablation results in better isolation of the pulmonary veins, and improvement in clinical outcomes in addition to other surrogates such as procedure time and radiation dose, when compared with non‑contact force‑guided ablation. The shaft controls the plane of the curved catheter tip allowing it to be rotated for accurate positioning. Load Time 0.06 seconds • System time 2020-10-14 19:11:09. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. Artisan Extend Control Catheter used with the Sensei X2 Robotic System (Hansen Medical). The manufacturer states that the patient having had a ventriculotomy or atriotomy within the preceding 4 weeks and the presence of a prosthetic valve are contraindications for using ThermoCool SmartTouch. Biosense Webster has provided the following list prices (excluding VAT). The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. During the study the adhesiveness properties of the patches will be evaluated. a git repository would be checked if the GIT_TAG does not refer to a specific commit). In producing guidance, NICE aims to comply fully with all legal obligations to: promote race and disability equality and equality of opportunity between men and women. Another commentator agreed that what constitutes good contact and sufficient force is less well defined in the literature. ThermoCool SmartTouch can only be used with Biosense Webster radiofrequency generators, such as the SMARTABLATE system with integrated irrigation pump (£35,000) or the Stockert EP Shuttle radiofrequency generator used with the separate COOLFLOW irrigation pump (£14,999 and £8,999 respectively). The catheters comprise several parts: A deflectable distal section containing several electrodes, including a 3.5 mm tip electrode. Additional components needed for the ablation procedure include: The CARTO 3 navigation system, with SmartTouch 3D software module and integrated display screen, designed to visualise the real‑time calculated position and orientation of the catheter within the patient's heart. Cardiac perforation has been shown with force above 40 g; however, energy delivery not only involves contact force but also ablation time and radiofrequency power output. A separate mapping catheter can be used simultaneously, sequentially or interchangeably with ThermoCool SmartTouch. NICE interventional procedures guidance on percutaneous radiofrequency ablation states that the evidence for the safety and efficacy of this treatment for atrial fibrillation is adequate to support its use in appropriately selected patients, provided that normal arrangements are in place for audit and clinical governance. This allows a representation of part of catheter to be seen within the mapping system and contributes to the reduced need for fluoroscopy during catheter manipulation. Price: $10.00 per box of 2 In Stock: 0 box of 2: Status: expired: We currently do not have this item in … ThermoCool SmartTouch transmits contact force information to the clinician throughout the procedure using the CARTO 3 navigation system (which is commonly used in electrophysiology). Information provided by (Responsible Party): The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. One specialist commentator highlighted that contact force capability should allow more effective and safer ablation of complex arrhythmia substrates, and should not be restricted to treating atrial fibrillation. One specialist commentator highlighted that the main difference between ThermoCool SmartTouch and previous navigation catheters is the ability to visualise the shaft electrodes using the CARTO 3 navigation system. Other cardiac ablation procedures are described in related interventional procedures guidance (see relevance to NICE guidance programmes). One specialist commentator noted that real‑time dynamic contact force feedback during cardiac ablation procedures would enable operators to adjust catheter position, improve procedure efficacy and increase safety by avoiding the application of excessive force. For general information, Learn About Clinical Studies. Using either the CARTO or NavX system, the 3-D shell representing the LA and PVs is constructed using the ablation or ring catheter, or both. Page 1. ThermoCool SmartTouch is inserted through the introducer sheath and manually moved through the blood vessels in order to map the site of the abnormal heart rhythm. In some cases the clinician may prefer to use a separate mapping catheter to identify the site of the abnormal heart rhythm and confirm electrical isolation of the pulmonary veins. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The manufacturer provides onsite training by a clinical support specialist as part of the overall service, at no cost. This blocks the electrical path that causes the abnormal heart rhythm. Read our disclaimer for details. We use cookies for Google Analytics and session tracking for your secure shopping experience. ThermoCool SmartTouch uni‑directional catheter, first CE marked in February 2011. This website also uses Open Source Software (OSS) provided by LiveChat to provide customer support. The manufacturer, Biosense Webster, has a CE certification dated November 2015 that includes the following catheters: ThermoCool SmartTouch bi‑directional catheter, first CE marked in December 2010. Each single‑use ThermoCool SmartTouch costs £1,675 (uni‑directional) or £1,750 (bi‑directional). This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to.

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