CivaSheet®

CivaSheet

CivaSheet is the only FDA cleared, unidirectional, planar brachytherapy source. It is flexible, bioabsorbable and features CivaTech’s proprietary polymer encapsulated source technology. The CivaSheet utilizes Pd-103, a medical radioisotope known to be effective in the treatment of cancer. The CivaSheet sources offer gold shielding on one side, virtually eliminating the exposure on the shielded side, providing unidirectional radiation exposure. The shielding was designed to spare radio-sensitive healthy tissue while allowing radiation oncologists to deliver a full dose on the active side. “Gold is Cold”  is commonly used as a simple way to keep track of the shielded side.

CivaSheet is manufactured with the prescribed source strength according to the patient’s overall therapy plan. Upon completion of the manufacturing assembly process, the device is inspected to assure compliance to the specifications. The devices are tested according to Standard Operating Procedures (SOPs) acceptable to ISO 13485 (the highest international quality standard available for medical device manufacturers), cGMP and FDA requirements. CivaSheet is manufactured in an ISO Class 7 clean room and shipped after sterilization. CivaSheet can be cut in the operating room to re-size and / or reshape the device to conform to the surgical cavity / margin.

Source dosimetry data will be provided by CivaTech Oncology. The data complies with AAPM-TG43 format and provides all the required parameters to model the source and its high anisotropy. Medical Physicists and Radiation Oncologists at your clinic will have access to all the required files prior to the generation of the treatment plan.

The CivaSheet:

  • Can be administered in an inpatient or outpatient setting

  • Provides radiation therapy in one visit with significantly reduced side effects

  • Is highly conformal and allows treatment to difficult to reach cancer sites

  • Can be ordered in custom prescription strengths

  • Can be cut to size in the operating room

  • Can be used with, or in place of other radiation treatments (EBRT, SRS, IORT etc…)

  • Is unidirectional to spare healthy tissue

  • Eliminates the need for fractionated radiation treatments in many cases

  • Is FDA Cleared for use as IORT, adjuvant or neo- adjuvant radiation therapy

  • Is compatible with MRI, CT and modern 3D treatment planning software

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