Technology | September 16, 2014

CivaTech Oncology Receives FDA Approval for CivaSheet Brachytherapy Device

September 16, 2014 — CivaTech Oncology announced it has received U.S. Food and Drug Administration (FDA) clearance on its bioabsorbable planar radiation device. The implantable CivaSheet low-dose-rate (LDR) Palladium source is the only membrane-like brachytherapy device that is truly customizable to a specific patient’s condition and offers a unidirectional option to shield healthy tissue. The product was designed for use either during surgery or with standard, less invasive, implant devices.

Brian J. Moran, M.D., medical director of Chicago Prostate Center, believes the CivaSheet “potential could be huge. It may offer advantages due to its size and directional radiation emissions.” The ability to customize directionality in a planar configuration will help radiation oncologists treat a variety of cancers such as soft tissue sarcoma, early-stage non-small-cell lung cancer, head and neck cancer, colorectal cancer, ocular melanoma and skin cancer.

“We are very excited about the beneficial impact this can have for all of the patients whom are candidates for this new treatment option,” said CivaTech Oncology executive chairman and CEO Suzanne Babcock. “For the first time, radiation oncologists will have a configurable planar LDR array that is truly customizable to a specific patient’s condition, allowing clinicians to specify a tailor-made dose distribution that can be unidirectional or bidirectional.

CivaSheet will be the first commercially available polymer encapsulated bioabsorbable brachytherapy device that has integrated radiation shielding, allowing broader applications where previously risk of harming healthy tissue was problematic. CivaSheet development was partially supported with funding from the National Institutes of Health (NIH), National Cancer Institute (NCI) and the North Carolina Biotech Center.

For more information: www.civatechoncology.com

Related Content

MedStar Georgetown Proton Center Selects RayStation for Treatment Planning
News | Treatment Planning | August 17, 2017
August 17, 2017 — The proton center at MedStar Georgetown University Hospital will utilize RayStation for planning on
DOSIsoft Releases ISOgray Proton Therapy Treatment Planning System
Technology | Treatment Planning | August 15, 2017
DOSIsoft SA announced the official release, with CE marking, of ISOgray Treatment Planning System (TPS) release 4.3 for...
First Radixact Results Presented at AAPM 2017
News | Radiation Therapy | August 10, 2017
Accuray Inc. announced that the first studies validating the benefits of the Radixact System were presented at the 59th...
Clinical Data Supports Use of Xoft System for Endometrial Cancer
News | Brachytherapy Systems | August 03, 2017
Researchers presented clinical data supporting use of the Xoft Axxent Electronic Brachytherapy (eBx) System for the...
Aktina’s interchangeable cones are lightweight and extremely accurate
News | Radiation Therapy | August 02, 2017
Aktina Medical announced a collaboration with Philips Medical Systems and Elekta Instruments for SRS interlocking at...
News | Image Guided Radiation Therapy (IGRT) | July 31, 2017
Elekta’s magnetic resonance radiation therapy (MR/RT) system will be the subject of 21 abstracts at the 59th American...
Accuray Receives 510(k) Clearance for iDMS Data Management System
Technology | Oncology Information Management Systems (OIMS) | July 31, 2017
July 31, 2017 — Accuray Inc. announced it has received 510(k) clearance from the U.S.
more healthcare providers and patients are choosing options such as Gamma Knife stereotactic radiosurgery
News | Radiation Therapy | July 31, 2017
Each year, up to 650,000 people who were previously diagnosed with various forms of cancer will develop brain...
Overlay Init