News | March 19, 2008

Siemens Urological Solutions Receive Market Clearance

March 20, 2008 – Siemens Medical Solutions received FDA 510(k) market clearance for the sale and distribution of two solutions for urological applications: Lithoskop and Modularis Variostar, both featuring LithoReport, a lithotripsy software tool that enables the detailed and automatic acquisition of the entire therapeutic process.

Lithoskop includes a shockwave head for flexibility and encompasses lithotripsy, endourology, urodiagnostics and percutaneous interventions. Lithoskop features stone localization with X-ray, inline ultrasound imaging and its high-performance X-ray generator and image intensifier with 1 K2 matrix works to provide reliable image quality for optimal diagnosis and therapy. The system also features AutoPos, a computer-aided 3D-positioning software that reportedly automatically moves the patient into the right position for therapy after stone localization.

Lithoskop provides a penetration depth of 16 cm, making it useful for bariatric patients. According to the company, almost all stones can be disintegrated in only one session.

Modularis includes components that can be used separately or in combination. The Modularis Variostar lithotripter is the comfort version within the Modularis product family and features a complete range of ergonomic features. The urology platform is designed for a variety of applications, including traditional urodiagnostics, extra- and intracorporeal shockwave therapy (ESWL, ISWL) and endourological interventions.

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.

For more information: www.siemens.com/medical

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