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Elekta Harmony Radiotherapy System Receives FDA 510(k) Clearance

elekta-harmony-fda-clearance

Elekta has today announced that its Elekta Harmony* radiation therapy system has secured U.S. FDA 510(k) clearance, paving the way for U.S. clinics to harness the system to treat a comprehensive range of indications using the latest radiotherapy techniques. Harmony perfectly balances productivity and precision without compromise, making the system well-suited to address changing U.S. demographics and practice patterns.

“The cancer burden in the United States and worldwide is increasing significantly, arising not just from an aging population, but also from delayed diagnoses and treatments due to Covid-19,” notes Larry Biscotti, Elekta’s Executive Vice President Region North & Central America. “Harmony was designed not only to enable the latest advanced radiotherapy techniques, but also to simplify and streamline the radiotherapy process, with guided workflows and a user interface that facilitates a short learning curve. The interface gives the treatment staff all the information they need where they need it. The results are shorter treatment times, greater productivity and more patients treated.”

“Research results are pointing to the clinical value of hypofractionation for a variety of malignancies, including prostate, breast, and lung cancers,” adds John Christodouleas, MD, MPH, SVP of Medical Affairs & Clinical Research Linac-Based RT. “The trends in patterns of care data suggest that hypofractionation – enabled through systems capable of stereotactic body radiotherapy [SBRT] – is going to be routine at all radiotherapy centers,” he says. “If only 10 percent of metastatic carcinoma patients are treated with SBRT once or twice throughout their treatment course, SBRT will be in considerable demand. When we designed Harmony, SBRT indications were a priority.”

A versatile system that can operate effectively in highly distributed, suburb-based radiotherapy clinics that are part of a larger network is also valuable, Christodouleas says.

“In cancer care, we’re seeing a shift in which networks are siting many machines to cover large geographic areas to bring treatment closer to where people live,” he observes. “These networks need delivery systems that can handle both technically demanding treatments like SBRT and also more conventional IGRT regimens. Harmony was built as an efficient, versatile linear accelerator allowing clinicians to treat more patients with high-quality precision radiation therapy.”

Harmony will provide enhanced:

  • Productivity: the new FastTrack in-room experience reduces patient setup time by as much as 50 percent.** Combined with further workflow enhancements, treatment slots can be reduced by up to 25 percent**, enabling clinicians to deliver high-quality cancer care to more patients.
  • Precision: a best-in-class multi-leaf collimator provides one-millimeter resolution beam-shaping across the full 40 cm X 40 cm field size, which provides “shrink-wrapped” sub-millimeter conformality around the tumor target.
  • Versatility: the option of multiple energies, treatment techniques and imaging modalities, providing the versatility needed to treat the most common indications, including breast, lung, pelvic and head-and-neck cancers.

To register for the launch event, visit: https://findyourbalance.elekta.com/us/.

*Elekta Harmony has CE mark and U.S. FDA 510(k) clearance. Not available in all markets.
**Data maintained internally

Source: Elekta

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