Integra - Extracorporeal Shockwave Lithotripsy (ESWL)
Integra incorporates a novel shockwave technology, innovative imaging and a revolutionary architecture oriented toward fragmentation effectiveness and accurate imaging. Integra is a single unit, including a fluoroscopy system, treatment table and shockwave unit all in one. This architecture dramatically reduces coupling, set-up and treatment time.
The vertically positioned shockwave source makes patient positioning easy and quick and offers in-line fluoroscopy without the need to delay the treatment procedure ("On-line"). Integra's unique One View Localization method replaces the need to rotate the X-ray unit and allows for a concise design and footprint. A user friendly physician's console enables complete control of the procedure as well as advanced image processing functions.
Vertical Shock Wave Orientation/Delivery Through the Patient's Back
The majority of lithotripters in the market use the lateral shockwave orientation. Integra uses a vertical orientation shockwave source instead of lateral orientation. Delivering shock waves through the back entails a series of advantages, including:
A. Short distance between the source and the target stone (about 40% reduction), improves treatment efficiency. The shorter the distance the shockwave has to travel inside the body the less energy is dispersed and hence fragmentation efficiency increases.
B. Shockwave path to kidney passes mainly through muscles and not through intestines which may contain gas. This leads to better energy efficiency since gas blocks the propagation of shockwaves.
C. In-line X-ray Imaging which allows imaging the exact shockwave pattern.
Integra's Imaging Advantages
Several unique imaging functions have been incorporated in the Integra system including real time (On-line) fluoroscopy and an optional ultrasound imaging module compatible with all major ultrasound units. Both can be used for localization as well as treatment monitoring on the Integra console's screen and can be achieved without halting the treatment session.
"In Line"/ "On line" Fluoroscopy: The Best of Both Worlds
Since common fluoroscopy imaging orientation is vertical, an "in-line" shockwave must also be in a vertical orientation (aimed through the patient's back). Initia's special design is unique in such that it allows In-line fluoroscopy image acquisition in real time (On-line) without stopping the treatment session, making it the only such system offered today. Integra's unqiue Electromagnetic Generator allows the physician to view a full 9" image In-line with the shockwave path that greatly enhances target localization/recognition in real time; during the course of the shockwave treatment.
To avoid using complex air-bag systems that require a halt in the treatment session when a full fluoroscopy image is needed, Integra uses the unique "Air-Duct" design which allows continuous X-ray imaging at any time, without having to stop the treatment. This technology also allows exposing the whole 9"range, without any additional operations at any time.
Integra allows the best of both worlds: In Line and On line Fluoroscopy.
Ultrasound Imaging Module
Integra can be provided with an optional ultrasound imaging module. The module is horizontally located and offers an alternative imaging modality for real time treatment session monitoring. The conventional abdominal probe can be easily removed from the module for easy scanning of the kidney region. The ultrasound, and the fluoroscopy image, are both displayed on the user console screen.
One View Localization
Integra introduces the innovative One View Localization System (FDA approved) making it the only ESWL system today that allows perfect localization of the target by using vertical views at two horizontal positions. In order to achieve localization with the Integra, all that is needed is to move the fluoroscopy unit on the XYZ axes. This method replaces the need for tilting the fluoroscopy unit in order to achieve images at different angles.
Integra incorporates some of the more interesting software features available today in the field of ESWL.
TEM Technology - Transducer Efficiency Monitoring
Most electromagnetic ESWL systems in the market today suffer from the same phenomenon; whereas the electromagnetic transducer that generates the shockwaves, experiences declined efficiency towards the end of its lifespan. This deterioration in the transducer efficiency causes reduced treatment results. TEM is a unique Direx-Initia feature that allows the calculation of the transducer energy efficiency in real time. The system alerts the operator when optimal energy generation is approaching its end and defines when the transducer replacement is required.
Replacement of the shockwave transducer ensures clinical efficiency will maintain a maximum level at all times and replaces the old method of replacing transducer units only when the unit fails completely.
Integra is offered with a 1 million shocks warranty for its shockwave transducer unit so all replacements of the unit is dictated by the TEM system and are included in the same price and are, therefore, no financial burden to the user.
Image Processing and Control
Integra's Image Processing and Control (IPCON) software includes comprehensive image processing functions, a detailed database of patient/treatment parameters and images and all necessary controls of the system operation.
The Integra system integrates with PACS system within the same network. Supporting the DICOM3 standard, Integra enables storage and printing PACS files like x-ray and ultrasound from Integra's IPCON imaging station to your hospital central PACS archive as well as verify and media interchange CD ROM standard.
During lithotripsy treatments: images and patient's data acquired can be stored in the central PACS archiving station (hospital server) or printed on a remote printer: Printing from IPCON using Windows API to a standard printer or using a DICOM function to a remote DICOM printer.
Symmetrical Treatment for Left/ Right Stones
Integra's reflector is located at the center of the table, so that the patient orientation is always the same irrespective of whether we treat a right or left kidney stone.
The unique architecture of the Integra allows localizing stones precisely using only horizontal movements and a simple mathematical triangulation algorithm.
The Integra's shockwave source and the vertically positioned fluoroscope are mechanically attached as a single assembly, operable to move in three dimensions in contrast to the incorporated treatment table.
Integra is highly mobile and compact (footprint = 2x1m) and does not require pre-treatment mechanical alignment of shockwave source and fluoroscope since in fact they are built as a single mechanical unit.
Integra has a Super-Compact Design - 1m x 2m Footprint