Elekta receives FDA clearance for Leksell Gamma Knife Perfexion

By E. Janene Geiss

Philadelphia, Aug. 23 - Elekta said Wednesday that the Food and Drug Administration on Monday issued a 510(k) pre-market clearance for Leksell Gamma Knife Perfexion, which allows the company to market the new system for stereotactic radiosurgery, in the U.S. market.

With Leksell Gamma Knife Perfexion, Elekta said it expands the Gamma Knife 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 and neck regions, according to a company news release.

Compared to earlier models, Leksell Gamma Knife Perfexion allows for a dramatically increased treatable volume, officials said.

Subsequently, the new system is estimated to increase the number of patients that can benefit from Gamma Knife surgery by up to 40% while maintaining full clinical compatibility with Gamma Knife procedures and protocols based on nearly 400,000 treated patients.

The fully automated and efficient single push button approach is expected to save three to five working weeks of physician time per year at an average Gamma Knife center, officials said.

Designed with patient and staff comfort in mind, the unwanted body dose to patient is up to 100 times less with Leksell Gamma Knife Perfexion, compared with competing technologies. That is important for pediatric treatment and treatment of women of childbearing age, officials said.

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

Elekta is Stockholm, Sweden, medical technology company.

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