3D Guidance MedSAFE fully meets electrical safety regulation and is classified as a Class 1, Type CF, Defib Proof device for use within the human body. Measurements are unaffected when tracking in close proximity to intravascular ultrasound arrays, composite beds, low frequency noise sources, and common hospital metals, such as 300-series stainless steels, titanium, and aluminum.
When used with its flat magnetic field generator, 3D Guidance MedSAFE measurements are also immune from ferromagnetic metals beneath its planar surface, such as structural members in OR and procedural tables. Ascension's current "radiopaque" flat transmitter is designed for procedures not requiring fluoroscopy. Under development is a "radiolucent" flat transmitter, containing an open centre, for compatibility with X-ray fluoroscopy. It enables accurate 3D tracking, near a C-Arm fluoroscope, without degradation or signal loss.
The new sensor can be integrated into catheters and needles as small as 3 French/20 gauge. Micro-miniaturized sensors accurately measure the X, Y, Z position and yaw, pitch orientation - five degrees of freedom - of embedded coils, up to 375 times a second at accuracies in the millimeter range. Its assembly addresses the clinical requirement for unobtrusive integration of sensors into a wide range of tools for in vivo visualization and navigation. Sensors ranging in size as small as 1,3 mm wide are available for six degrees-of-freedom tracking of instruments.
Jack Scully, Ascension's Vice President of New Business Development, stated: "Now that our third generation DC magnetic devices are operational, we are focusing on environmental issues that have limited widespread use of navigational devices in flexible surgical tools. At RSNA, we are showing the results of ongoing work to integrate 3D tracking into image-guided tools that are easy to use, low profile, and highly reliable."
At RSNA, 3D Guidance MedSAFE is also shown integrated with medical imaging software from Cedara Inc. Its NavAssist software provides the building blocks for the creation of customized software solutions for image guidance and visualization.
Ascension Technology Corporation, based in Burlington, Vermont, USA, is a world expert in magnetic guidance and localization solutions for medical navigation. More information about Ascension's sensors is available at the Ascension website or in the VMW November 2007 article Ascension announces breakthroughs in catheter navigation at TCT 2007.