FDA News

HealthTronics Announces FDA Clearance and Launch of the New LithoDiamond ULTRA Lithotripter

(May 15, 2007)-- HealthTronics, provider of urology services and products, announced the launch of its LithoDiamond ULTRA lithotripter providing an evolution in lithotripsy treatment technology.

FDA clearance of the equipment has been granted and over fifty patients have been treated. This platform evolution is the largest advancement in lithotripsy technology in more than a decade and is based on the significant input from our urologist partners and clinicians in the urology community. The LithoDiamond ULTRA has five unique clinical features that define it as the most technologically and clinically advanced lithotripter available in the global marketplace today. These features include:

• “Source Select” technology which provides both electrohydraulic, or “spark gap” therapy delivery, as well as electromagnetic therapy delivery (the capability of two units in one, providing enhanced treatment options)
• Rotating therapy head that provides unencumbered access to both sides of the patient for treating kidney and lower ureteral stones in either the supine or prone position
• Integrated iso-centric C-arm and image chain which provides optimal image quality to visualize stones in the kidney and ureter
• Mobile platform consisting of only two components for excellent portability and productivity
• Table functionality that allows for cysto, prostate and other surgical procedures

The first patient treatments were conducted by David Allen, MD of Athens, GA who stated: “We treated four cases on the ULTRA, two with the electromagnetic therapy head and two with the electrohydraulic therapy head. Changing therapy heads between cases was a simple procedure and having the ability to choose the electrohydraulic head with a deeper penetration depth is a great option for larger patients which is one of the fastest growing market segments in medicine today. The image quality on the ULTRA provides for excellent stone localization. This lithotripter is a versatile product with a bright future.”

Christopher Schneider, President of Medical Products commented: “HealthTronics has always been a strong player in electrohydraulic lithotripsy technology but has never invested in the other 50% of the lithotripsy market which consists of electromagnetic technology. The LithoDiamond ULTRA is the first unit ever produced to combine both technologies on one unit. Now, a provider can satisfy the clinical requirements of all urologists by purchasing one unit that offers both types of therapy rather than purchasing two single technology units. This combination of technology can potentially reduce a provider’s lithotripsy capital costs in half. We are excited about the next generation brand of LithoDiamond which demonstrates a continuum of technology, preceded by our 190 lithotripters installed in the United States and our additional 140 lithotripters installed internationally.”

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