LEKSELL GAMMA KNIFE® PERFEXION™ RECEIVES REGULATORY APPROVAL IN JAPAN

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Press Release
Stockholm, Sweden, May 26, 2008

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.

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