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Elekta Receives FDA Clearance for Leksell Gamma Knife(R) Perfexion(TM)

Posted on: Wednesday, 23 August 2006, 12:00 CDT

STOCKHOLM, Sweden, Aug. 23 /PRNewswire/ -- On Monday, August 21, the U.S. Federal Drug Administration (FDA) issued a 510(k) pre-market clearance for Leksell Gamma Knife(R) Perfexion(TM), allowing Elekta to market this innovative new system for stereotactic radiosurgery also on the U.S. market.

(Photo: http://www.newscom.com/cgi-bin/prnh/20060823/CLW026) (Logo: http://www.newscom.com/cgi-bin/prnh/20020318/ELEKTALOGO)

With Leksell Gamma Knife(R) Perfexion(TM), Elekta expands the Gamma Knife(R) product line with a completely new system that takes stereotactic radiosurgery to the next level and provides a platform for further refinement and expansion of radiosurgery procedures in the brain, cervical spine and head & neck regions.

Compared to earlier models, Leksell Gamma Knife(R) Perfexion(TM) allows for a dramatically increased treatable volume. Subsequently, this new system is estimated to increase the number of patients that can benefit from Gamma Knife(R) surgery by up to 40 percent, while maintaining full clinical compatibility with Gamma Knife(R) procedures and protocols based on nearly 400,000 treated patients. The fully automated and efficient single push button approach is expected to save 3-5 working weeks of physician time per year at an average Gamma Knife(R) center.

Designed from the ground up with patient and staff comfort in mind, the unwanted body dose to the patient is up to 100 times less with Leksell Gamma Knife(R) Perfexion(TM), compared with competing technologies. This is also important for pediatric treatment and treatment of women of childbearing age.

The new system also comes with Leksell GammaPlan(R) PFX(TM), a new client- based treatment planning system with remote capabilities which provides all the tools needed to make full use of the sophistication and new features of Leksell Gamma Knife(R) Perfexion(TM). Leksell GammaPlan(R) PFX(TM) received its US FDA clearance in July, 2006.

"We are very pleased with the FDA clearance after a shorter than expected process. Leksell Gamma Knife(R) Perfexion(TM) has been met with very strong interest from neurosurgeons and radiation oncologists from all over the world and not least in the United States. These current and future Gamma Knife(R) users are impressed with the expanded clinical applications, flexibility, ease of use and workflow enhancement of this revolutionary new system for stereotactic radiosurgery," says Tomas Puusepp, President and CEO of Elekta. "This is an important step in the launch of Leksell Gamma Knife(R) Perfexion(TM), allowing us to initiate marketing and to start signing orders on this important market."

About Elekta

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(R) for non- invasive treatment of brain disorders and Elekta Synergy(R) 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 approximately 1,850 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 http://www.elekta.com/.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20060823/CLW026http://www.newscom.com/cgi-bin/prnh/20020318/ELEKTALOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com

Elekta, Inc.

CONTACT: Media Inquiries, Michelle Lee, PR and Advertising Manager,+1-770-670-2447, or michelle.lee@elekta.com ; or Investor inquiries, PeterEjemyr, Group VP Corporate Communications, +46 733 611 000 (mobile), orpeter.ejemyr@elekta.com , both of Elekta, Inc.

Web site: http://www.elekta.com/

Source: PRNewswire

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