Search Results

The MAGELLAN™ system, which is comprised of a medical workstation, a magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions: - process and display pre-operatively radiographic images on a monitor; . - provide intra-operative image control based on the position and orientation of a . user directed tool; - . allow for the integration and usage of the Blosense magnetic location system and a range of different tool attachments; and - store/retrieve image data on computer access media (e.g. hard disks, archive . media) Circumstances: The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considered, and also during surgery when: - . the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy; - 방 the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery; - the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotiated; Or - the target delineation is important and will not move significantly during the . implementation of the approach (e.g. skull-based tumors. sinus diseases, corpus callosotomies). I Jisease or Conditions: The MAGELLAN™ system is indicated for patients who have imaged space occupying lesions or malfunctions (both soft tissue and osscous) in the head.

The Magellan system is a subset of the CARTO system. The CARTO system consists of the location system and the viewing station for the EP application combined together in one product. The Magellan system is the same location system used in CARTO, to be sold separately for use with a range of different 510(k) approved locatable accessory devices and viewing stations for applications.

The Biosense NOGA system is designed to acquire, analyze, and display electroanatomical maps of the human heart.

The Biosense NOGA system is designed to acquire, analyze, and display electroanatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of a plurality of intracardiac electrograms with their respective endocardial locations. In the NOGA system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using STAR catheters, which are locatable-tip catheters equipped with a Biosense sensor. The NOGA system also allows presentation of electro-anatomical maps as a function of time over the cardiac cycle. The NOGA system is for the most part identical in design and construction to the Biosense CARTO system. The NOGA system uses the same Biosense nonfluoroscopic location technology used in the CARTO system. The NOGA system additionally uses this technology to collect additional information about the heart chamber geometry as a function of time over the cardiac cycle.