EDAP, a provider of therapeutic ultrasound devices, has received the European approval for its new lithotripter, the Sonolith i-move. The EDAP expects to begin marketing Sonolith i-move immediately and to officially introduce the product to distributors, partners and visiting urologists at the European Association Urology (EAU) congress.
EDAP said that the patented electroconductive technology Sonolith i-move is a compact, stand alone lithotripter with a revolutionary infrared stereo-vision system for real-time, three-dimensional ultrasound localization of urinary stones. With its various modular configurations, Sonolith i-move targets the lithotripsy market segment, offering a wide range of treatment procedures for mid-size clinical sites and hospitals.
According to EDAP, Sonolith i-move is expected to replace Sonolith Praktis, an earlier generation lithotripter, and complements the company’s high-end Sonolith I-sys lithotripter, an integration of x-ray and ultrasound locatization systems.
In addition to the official launch in Europe, EDAP is actively working towards filing for regulatory approval of Sonolith i-move in the US and in Japan.
Hugo Embert, ESWL product manager of EDAP, said: “With the addition of Sonolith i-move, EDAP is the only company in the extracorporeal shock wave lithotripsy market covering all market segments, offering the widest range of lithotripters, from standard compact devices to high-end, fully integrated lithotripters.
“We look forward to the official introduction of Sonolith i-move during next week’s EAU congress. This is the optimal forum for our sales team and distribution partners to promote and market our latest lithotripter. We encourage members of the urology community to stop by our booth and experience Sonolith i-move first hand.”
Marc Oczachowski, chief executive officer of EDAP, said: “The launch of Sonolith i-move validates EDAP as a leader in the development and innovation of high-end technology. Importantly, the European approval highlights our ability to successfully navigate regulatory processes and obtain approvals for multiple devices in major global markets. We will continue to focus on providing the minimally invasive technologies for patients and physicians.”