March 20, 2008 - Siemens Medical Solutions has received FDA 510(k) market clearance for the sale and distribution of two solutions for urological applications: Lithoskop and ModularisVariostar.
Encompassing lithotripsy, endourology, urodiagnostics and percutaneous interventions, Lithoskop is a multifunctional, high-end system for many urological applications, said Siemens.
Its flexible shockwave head allows for treatment without patient repositioning. The system offers stone localization with X-ray, as well as inline X-ray and inline ultrasound imaging. Lithoskop�s high-performance X-ray generator and powerful image intensifier with 1 K2 matrix reportedly delivers reliable image quality for optimal diagnosis and therapy. AutoPos, a computer-aided 3D-positioning software, automatically moves the patient into the right position for therapy after stone localization.
Based on Pulso, Lithoskop provides a new and efficient shockwave system with an extensive lifecycle, said the company. With a penetration depth of 16 cm, Lithoskop is reportedly well suited for bariatric patients. Almost all stones can be disintegrated in only one session.
The shockwave head is mounted on an isocentric C-arm that can be moved from the undertable-left or undertable-right position, to the overtable position with the push of a button. This allows the left and right kidney, as well as the ureter, to be treated without repositioning the patient.
Modularis Variostar provides a proven and enhanced urology platform that consists of components that can be used separately or in combination, Siemens said. The Modularis Variostar lithotripter is the comfort version within the Modularis product family and, with a complete range of ergonomic features, which simplifies operation and daily workings, within the unit.
Featuring a modular design, the Modularis urology platform is suited for a variety of urology applications, including traditional urodiagnostics, extra- and intracorporeal shockwave therapy (ESWL, ISWL) and endourological interventions. The system can handle urological clinical requirements, and is designed for every need and budget. When configuring Modularis, there is a choice of two lithotripsy modules: Modularis Variostar (comfort version) with flexible treatment positions, and Lithostar Modularis Vario (standard version) with a universal coupling mechanism for C-arm systems. The Modularis Uro endourology table and a mobile C-arm system are included as part of the basic configurations for urodiagnostics and lithotripsy.
The therapy head of the Modularis Variostar can be moved above and below the treatment table. This flexible positioning offers freedom for conventional and case-specific stone treatments. As a result, the patient can remain in a comfortable supine position during stone therapy. All modules can be controlled centrally using the new, intuitive remote control. Even C-arm angulation, which is required for localizing the stone, can be triggered automatically. In addition, the physician can easily check the position of the lithotripsy module relative to the C-arm using an integrated focus control.
Together with the integrated Cplus shock wave system, the new lithotripsy module utilizes an electromagnetic system with a long lifespan (providing up to 1.5 million shots). With a total of 38 energy levels, the module can be set individually to meet anatomical and clinical requirements.
Both, Lithoskop and Modularis Variostar feature LithoReport, a lithotripsy software tool that enables the detailed and automatic acquisition of the entire therapeutic process.
For more information: www.usa.siemens.com/medical