Lithoskop and Modularis Variostar Receive FDA 510(k) Market Clearance
MALVERN, Pa., March 19 /PRNewswire/ -- Siemens Healthcare (http://www.usa.siemens.com/healthcare) has received FDA 510(k) market clearance for the sale and distribution of two solutions for urological applications: Lithoskop(R) and Modularis(R) Variostar.
"With the success that Lithoskop and Modularis Variostar have had worldwide, we are excited with the opportunity to deliver these solutions to the U.S. market," said Anders Steiner, vice president, Special Systems, Siemens Medical Solutions USA, Inc. "Both products were designed with patient comfort and ease of use in mind, as well as improving workflow."
Encompassing lithotripsy, endourology, urodiagnostics, and percutaneous interventions, Lithoskop is a multifunctional, high-end system for many urological applications. Its unique and flexible shockwave head makes patient repositioning a thing of the past.
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 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. With a penetration depth of 16 centimeters, Lithoskop is 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. 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 the longest lifespan in the industry (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.
About Siemens Healthcare
Siemens Healthcare is one of the world's largest suppliers to the healthcare industry. The company is a renowned medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration. With its laboratory diagnostics acquisitions, Siemens Healthcare is the first fully integrated diagnostics company, bringing together imaging and lab diagnostics, therapy, and healthcare information technology solutions, supplemented by consulting and support services. Siemens Healthcare delivers solutions across the entire continuum of care -- from prevention and early detection, to diagnosis, therapy and care. The company employs more than 49,000 people worldwide and operates in 130 countries. In the fiscal year 2007 (Sept. 30), Siemens Healthcare reported sales of euro 9.85 billion, orders of euro 10.27 billion, and group profit of euro 1.32 billion. Further information can be found by visiting http://www.siemens.com/healthcare
|SOURCE Siemens Healthcare|
Copyright©2008 PR Newswire.
All rights reserved