Healthcare Industry News: stereotactic
News Release - July 13, 2006
Elekta Recieves U.S. Regulatory Approval for Treatment Planning on Leksell Gamma Knife(R) Perfexion(TM)STOCKHOLM, Sweden--(HSMN NewsFeed)--July 13, 2006--On July 5, the U.S. Federal Drug Administration (FDA) announced a 510(k) pre-market clearance for Leksell GammaPlan® PFX(TM), the treatment planning system developed for Leksell Gamma Knife® Perfexion(TM).
By the ongoing market introduction of Leksell Gamma Knife Perfexion, Elekta (STO:EKTA) expands the Leksell Gamma Knife® product line with a completely new system that takes stereotactic radiosurgery to the next level and provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head & neck regions. Leksell Gamma Knife Perfexion is pending 510(k) clearance from the FDA.
"Leksell GammaPlan PFX is a vital part of Elekta's brand new platform for stereotactic radiosurgery, providing unmatched ease-of-use and reaping the benefits of the highly innovative design of Leksell Gamma Knife Perfexion", says Vincent Denot, Elekta's Product Manager for Leksell GammaPlan. "This 510(k) pre-market clearance from FDA is an important milestone in the Perfexion project and yet another such event that is occurring exactly according to plan", Denot concludes.
Elekta is an international medical-technology Group, providing meaningful clinical solutions, comprehensive information systems and services for improved cancer care and management of brain disorders. All of Elekta's solutions employ non-invasive or minimally invasive techniques and are therefore clinically effective, gentle on the patient and cost-effective.
Clinical solutions include among others Leksell Gamma Knife® for non-invasive treatment of brain disorders and Elekta Synergy® for image guided radiation therapy (IGRT). Following the acquisition of IMPAC Medical Systems Inc. in April 2005, the Elekta Group is the world's largest supplier of oncology software.
Elekta's systems and solutions are used at over 3,000 hospitals around the world to treat cancer and manage clinical operations as well as to diagnose and treat brain disorders, including tumors, vascular malformations and functional disorders.
With approx. 1850 employees, Elekta's corporate headquarter is located in Stockholm, Sweden and the company is listed on the Stockholm Stock Exchange under the ticker EKTAb. For more information about Elekta, please visit www.elekta.com.
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