- The Radixact System, with the addition of the VitalHold
functionality, provides clinicians with unmatched choice of
radiation treatment delivery options in one device
- Treatment delivery versatility offers opportunities for
personalization and makes exceptional quality care possible for
more breast cancer patients
MADISON,
Wis., Aug. 9, 2023 /PRNewswire/ -- Accuray
Incorporated (NASDAQ: ARAY) announced today that the company has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its VitalHold™* breast package on the
Radixact® System. The treatment option will also be
available in the EU market. VitalHold facilitates deep inspiration
breath hold (DIBH) treatments using the Radixact System's fixed
beam angle delivery mode (TomoDirect™) and a fully integrated and
automated surface-guided radiation therapy (SGRT) solution,
featuring the Catalyst+ HD system from C-RAD. With the addition of
this new functionality, the Radixact System offers a comprehensive
tool set for the treatment of breast cancer. The VitalHold
technology will be available to customers in the United States and European Union as well
as other regions, subject to regulatory clearance or approvals.
DIBH treatments are often used to help minimize radiation dose
to organs at risk (OARs) and reduce associated complications later
in life. During treatment, a patient takes a deep breath which
moves the heart away from the chest wall and the targeted tumor.
The SGRT tracking system continuously monitors a patient's
breathing and position with cameras to confirm the patient is
appropriately positioned to deliver radiation. SGRT is designed to
enable medical care teams to effectively position the patient and
confidently monitor the accuracy of that positioning throughout
treatment.
"Our goal in introducing VitalHold for the Radixact System is to
provide clinicians with additional choice and flexibility when
treating the full spectrum of breast cancer cases they see daily in
their practice. Now, Accuray can offer our customers the widest
range of radiation treatment delivery techniques in one device, the
Radixact System. This industry-leading approach demonstrates how
our relentless focus on innovation has enabled Accuray to make an
already great system even better, providing clinicians with tools
that help ensure precise, truly personalized treatments are
achievable for more patients," said Suzanne
Winter, President and CEO of Accuray.
"C-RAD is incredibly proud of our collaboration with Accuray.
Together, we have created a seamless integration between our
systems to ensure the highest level of accuracy and efficiency for
the treatment of breast cancer," said Cecilia de Leeuw, CEO and President of C-RAD AB.
"VitalHold is a powerful application of C-RAD's proven SGRT
technology — and one that's sure to touch the lives of countless
breast cancer patients."
The CT linac based Radixact System offers multiple radiation
delivery options to tailor each patient's treatment based on their
specific needs. The system's extensive capabilities make it
possible for clinicians to treat breast cases in as little as 2
minutes. With TomoHelical™ mode, the Radixact System continuously
delivers radiation beams from 360 degrees around the patient,
enabling the treatment of complex cases, such as cancer in the
breast and surrounding lymph nodes. This approach also provides a
valuable option for patients who are unable to hold their breath,
which is key to undergoing DIBH treatments. TomoDirect
mode facilitates delivery of radiation from specific fixed
angles.
According to the National Cancer Institute, breast cancer is the
most common cancer diagnosed in women in the U.S., other than skin
cancers1. Radiation therapy plays a crucial role in the
management of early-stage, locally advanced, and metastatic breast
cancer cases. It is utilized in approximately 87 percent of breast
cancer patients2 and accounts for more than 25
percent of cases in most radiation therapy
departments3.
The Radixact® System with its unique radiation
delivery approaches offers advantages in the treatment of breast
cancer including the ability to deliver precise radiation dose to
any tumor bed, during every treatment, while minimizing dose to
nearby healthy organs and tissues. With the Radixact System,
radiation therapy may be an option for treating breast cancer at
almost every stage and can be used after surgery, chemotherapy and
other medications.
About Accuray
Accuray is committed to expanding the powerful potential of
radiation therapy to improve as many lives as possible. We invent
unique, market-changing solutions to deliver radiation treatments
for even the most complex cases—while making commonly treatable
cases even easier—to meet the full spectrum of patient needs. We
are dedicated to continuous innovation in radiation therapy for
oncology, neuro-radiosurgery, and beyond, as we partner with
clinicians and administrators, empowering them to help patients get
back to their lives, faster. Accuray is headquartered in
Madison, Wisconsin, with
facilities worldwide. To learn more, visit www.accuray.com or
follow us on Facebook, LinkedIn, Twitter, and YouTube.
Important Safety Information
For Important Safety Information please refer to
https://www.accuray.com/safety-statement.
Media Contact
Beth Kaplan
Accuray
+1 (408) 789-4426
bkaplan@accuray.com
*VitalHold™ availability is subject to regulatory clearance or
approval in some markets.
1 https://www.cancer.gov/types/breast
2 Shah C et al (2021) Advances in Breast Cancer
Radiotherapy: Implications for Current and Future Practice. JCO
Oncol Pract. 2021 Dec;17(12):697-706. doi: 10.1200/OP.21.00635.
Epub 2021 Oct 15. PMID: 34652952.
3 Harnett A (2010) Fewer fractions of adjuvant
external beam radiotherapy for early breast cancer are safe and
effective and can now be the standard of care. Why the UK's NICE
accepts fewer fractions as the standard of care for adjuvant
radiotherapy in early breast cancer. Breast. 2010 Jun;19(3):159-62.
doi: 10.1016/j.breast.2010.03.029. Epub 2010 Apr 24. PMID:
20456956.
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SOURCE Accuray Incorporated