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Devices Oncology FDA

 News Release - October 2, 2011

Nucletron, an Elekta Company, Receives FDA 510(k) Clearance for Precise Vaginal CT/MR Multi Channel Applicator

STOCKHOLM, Sweden--(Healthcare Sales & Marketing Network)--During the first day of the annual conference for the American Society for Radiation Oncology (ASTRO) in Miami, Nucletron, an Elekta company, today announced that it has received FDA 510(k) clearance for its new Vaginal CT/MR Multi Channel (VCMC) Applicator, offering a brachytherapy solution that enables very precise dose delivery for gynecologic cancers. Combined with Oncentra® treatment planning software this applicator makes it possible to reach new levels of workflow optimization.

“Our new vaginal applicator has been developed to fulfill the wish of many radiotherapists to deliver the radiation dose where it matters most, with greater precision. Thanks to a unique design featuring channels which follow the curve of the applicator tip, health care providers can now deliver radiation directly to the target area, while sparing surrounding healthy tissues,” says Jos Lamers, Executive Vice President, Elekta Brachytherapy Solutions. “The recent results of the PORTEC-2 study underlined the role of brachytherapy in preventing cancer recurrence in women following surgery for uterine cancer, while resulting in significantly lower side effects, and significantly better quality of life. The new VCMC will allow health care teams to build on these results in treating women with gynecologic cancers.”

Bringing the right dose to the right place is critical in successful vaginal brachytherapy. The Vaginal CT/MR Multi Channel Applicator provides accurate target coverage and maximizes conformity in the treatment of gynecologic cancers. It features Nucletron’s Precise Dose Delivery Solution (PDDSTM) technology, an innovative system that loads several source channels in the applicator, with a unique catheter geometry. This results in a dwell position that is very close to the target area, allowing for greater treatment precision. This applicator is designed to optimize the dose distribution to help prevent recurrence, while minimizing toxicity, side effects and impaired quality of life.

The VCMC Applicator is easy to assemble, clean and sterilize and integrates seamlessly with Nucletron’s Oncentra treatment planning software. Automatic reconstruction of the exact geometry of the applicator dramatically improves the speed of planning, and ensures precise and reproducible placement of the applicator.

The Vaginal CT/MR Multi Channel Applicator will be on display for demonstration during ASTRO’s annual conference October 2-4 in the Nucletron Booth #2001.

For further information, please contact:

Stina Thorman, Vice President Corporate Communications, Elekta AB Tel: +46 8 587 254 37, email: stina.thorman@elekta.com

Gert van Santen, Communications Director, Nucletron an Elekta company Tel +31653561242, e-mail: gert.vansanten@nl.nucletron.com

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 12.00 CET on October 2, 2011.

About Elekta

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 3,300 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.

About Nucletron, an Elekta company

Nucletron was recently acquired by Elekta and provides state of the art radiotherapy solutions for cancer treatment that meet the evolving needs of patients, their caregivers and healthcare professionals around the world. Nucletron has unmatched global leadership in brachytherapy, a very precise, highly effective and well-tolerated treatment option for healthcare providers, tailored to the needs of individual patients. The company works with clinical teams to constantly improve and develop an innovative portfolio of integrated products, software and services that assures excellent patient outcomes. Nucletron products are available in more than 100 countries around the world. Website: https://www.nucletron.com/


Source: Elekta

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