Healthcare Industry News:  Stereotactic 

Devices Oncology Regulatory

 News Release - May 26, 2008

Elekta: Leksell Gamma Knife(R) Perfexion(TM) Receives Regulatory Approval in Japan

STOCKHOLM, Sweden--(HSMN NewsFeed)--The Japanese Ministry for Health, Labor and Welfare, MHLW, has given approval for Leksell Gamma Knife® Perfexion™, the world-leading clinical solution for non-invasive radiosurgical treatments of tumors, vascular malformations and other brain disorders. Elekta, the international medical technology group and developer of Gamma Knife® surgery, will now be able to deliver and install this advanced technology at new and existing customer sites in Japan.

Gamma Knife surgery has become the world’s most widely used radiosurgery treatment due to its extraordinary accuracy, reduction of excess radiation dose to the body, extensive history and clinical documentation. Unlike other systems, invoking compromises in order to be able to treat the whole body, Leksell Gamma Knife is specifically designed to optimize treatment to the head and neck area – a fact appreciated by neurosurgeons and patients alike.

Launched by Elekta in 2006 and now in clinical use in over 30 locations around the world, Leksell Gamma Knife Perfexion combines the proven precision of the revolutionary Leksell Gamma Knife, with a dramatic increase in clinical reach to treat a wider range of targets faster and more efficiently than ever before. The system’s unique geometric and dosimetric design robotically administers thousands of beams of low-intensity radiation that converge to deliver a single, therapeutic dose of radiation with pin-point accuracy to the most difficult targets; while integrated treatment planning and delivery streamlines the radiosurgery process to treat even multiple brain lesions in a single automated procedure.

Over 50 centers in Japan are currently offering Gamma Knife surgery to patients with benign or malignant brain tumors, vascular malformations and certain functional brain disorders. Several of these have already expressed interest in upgrading their facility to Leksell Gamma Knife Perfexion. At the recent International Leksell Gamma Knife® Society Meeting on May 18-22, in Quebec, Canada, a large number of Japanese neurosurgeons and other clinicians attended and was presented with clinical data from the current users of Leksell Gamma Knife Perfexion.

About Elekta

Elekta is an international medical technology group, providing oncologists, radiation therapists, neurosurgeons and many other medical specialists with state of the art tools to fight serious disease.

Elekta provides advanced clinical solutions, comprehensive management and information systems as well as services for improved cancer care and management of brain disorders.

Elekta’s systems and solutions are used in over 5,000 hospitals around the world. Clinical and information management solutions include, among others, Leksell Gamma Knife® for non-invasive treatment of brain disorders, Elekta Axesse™ and Elekta Synergy® for Stereotactic and image guided radiation therapy and radiosurgery as well as the MOSAIQ™ suite of software for image-enabled EMR and efficient management of clinical and patient data.

With over 2,500 employees globally, the corporate headquarter is located in Stockholm, Sweden and the company is listed on the Nordic Exchange under the ticker EKTAb. More information about Elekta can be found at www.elekta.com.


Source: Elekta

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