A Medical Device Daily
EDAP TMS (Lyon, France), a developer of therapeutic ultrasound products, reported that the FDA has granted 510(k) marketing clearance for its newly designed, high-end Sonolith I-Sys device. Sonolith I-Sys is a novel, robotized device that has been developed by EDAP to provide a highly effective product configuration to address what is one of the largest lithotripsy markets in the world. The integrated lithotripter utilizes EDAP's unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined X-ray or ultrasound systems.
The Sonolith I-Sys received CE mark approval in July 2007 and was launched in the E.U. in late 2007. The device's superior x-ray and ultrasound imaging systems and user friendly features have contributed to its impressive adoption, positive treatment outcomes and high standards that benefit both patients and hospitals.
"We are very pleased that the FDA has granted 510(k) approval for Sonolith I-Sys, which marks a clear milestone for EDAP, further validates our technology and supports our objective to expand the Sonolith I-Sys into additional geographic territories," said Marc Oczachowski, EDAP's CEO. "With the U.S. approval, we will be positioned to enter one of the largest global markets for lithotripsy. This is an excellent opportunity for EDAP. We will now actively market Sonolith I-Sys and its patented electroconductive technology. We strongly believe that this is the most advanced and robotized lithotripsy system and that it will play a role in the high end market in the U.S. as it was designed to respond to the specificities of this established market."
Varian to equip Swedish proton therapy center
Varian Medical Systems (Palo Alto, California) reported that it has been selected to equip a new proton therapy center in Sweden. In a ceremony conducted by Swedish authorities following a public tender, Varian was named to supply an estimated $60 million in products for Skandionkliniken (Stockholm, Sweden), a new national proton therapy center owned by a consortium of seven of Sweden's counties. The center is scheduled to open in 2013. Varian hopes to book the order for the project before the end of the fiscal year upon review and approval of the tender process.
Public officials representing Skandionkliniken publicly disclosed the award on Aug. 19 when they met with Varian's management to sign the contract. Skandionkliniken is the first clinical center for proton therapy in Scandinavia.
"We are honored to be selected for this important project following a competitive bidding process and a thorough review of our proton therapy technology by numerous experts from across Sweden's radiation oncology community," said Varian president/CEO Tim Guertin. "This will be our first full installation for managing, planning, and delivering proton therapy, which we believe will be a powerful weapon in the battle to cure cancer. This award is a major milestone for the Varian Particle Therapy business."
Skandionkliniken, which will have two full treatment rooms as well as a fixed beam room for quality assurance and research activities, is expected to treat 1,000 patients per year in phase 1, and gradually expand to the full capacity of 2,500 patients per year. Varian will equip the center with a fully integrated system including its superconducting cyclotron, a beam line, and treatment room gantries as well as its ARIA software for information management and its Eclipse software for treatment planning. Varian will also have a five year service agreement valued at about $25 million.
The project marks the first time that the seven Swedish counties, representing eight university hospitals, have made a joint investment in a national center for cancer treatment. Under this collaborative model, university hospitals in each county will manage and plan proton treatments locally, and treat their patients at the new center.
The proton therapy consortium, called "The Joint Authority of County Councils for Advanced Radiation Therapy," was formed by the seven counties in 2006. The seven counties are: Uppsala, Ostergotland, Skane, Stockholm, Vasterbotten, Vastra Gotaland and Orebro. All eight University Hospitals in Sweden (Uppsala, Linkoping, Lund, Malmo, Stockholm, Umea, Goteborg and Orebro) will treat patients at Skandionkliniken. The public tender for the proton therapy system was issued in 2008.