Elekta Receives U.S. FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System for Cancer Treatment
Groundbreaking linear accelerator provides single system versatility to deliver sophisticated treatments for more patients and cancer types
STOCKHOLM, April 11 – Elekta recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing the company to begin shipping and installation of all components of the Versa HD™ system within the United States. Featuring high precision beam shaping and tumor targeting, and capable of delivering radiation doses three times faster than previous Elekta linear accelerators, Versa HD sets a higher benchmark for cancer treatment.
“We are delighted to receive FDA clearance,” says Jay Hoey, Executive Vice President, Elekta North America. “The potential clinical benefits for patients are significant. Further, the operational benefits for clinicians and providers are eagerly anticipated.”
Uniting high dose rate delivery with rapid MLC leaf speed
Fully integrated with the Agility™ 160-leaf multileaf collimator (MLC), Versa HD provides high-definition, high-speed beam shaping over a versatile 40 X 40 cm field. This unique combination of fast MLC leaf speed with the new High Dose Rate mode empowers clinicians to fully exploit high dose rate delivery and take advanced therapies such as VMAT, SRS and SRT to new levels – without compromising treatment times.
Versa HD also features:
• Industry-leading safety innovations
• Customizable, disease-specific configurations
• Modern patient-friendly ergonomics
• Fewer delays and downtime with real-time remote system monitoring
• Low environmental impact, low energy consumption design
Learn more at www.versahd.com.
Versa HD is not available for sale or distribution in all regions. Please contact your local Elekta representative for details.
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For further information, please contact:
Johan Andersson Melbi, Director, Investor Relations, Elekta AB
Tel: +46 702 100 451, email: firstname.lastname@example.org
Time zone: CET: Central European Time
Michelle Joiner, Director, Global Public Relations and Brand Management, Elekta
Tel: +1 770-670-2447, email: email@example.com
Time zone: ET: Eastern Time
The above information is such that Elekta AB (publ) shall make public in accordance with the Securities Market Act and/or the Financial Instruments Trading Act. The information was published at 11:00 CET on April 11, 2013.
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives.
Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,400 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker EKTAb. Website: www.elekta.com.