Dose verification system
DVS® (Dose Verification System) was developed by Sicel Technologies, a specialty device company focused on the development of innovative therapies for cancer treatment. It is the first and only implantable telemetric, radiation sensor that has been cleared for use by the U.S. Food & Drug Administration (FDA) in the treatment of breast cancer and prostate cancer.
About DVS
The device is used to measure the amount of radiation that is delivered to the tumor tissue, tumor bed and/or healthy tissue. DVS was developed to assist radiation oncologists in confirming the actual dose of radiation delivered to the tumor. Used in conjunction with planning and delivery tools, it provides information to deliver more consistent daily dose and optimized treatment plans to each patient.
The DVS sensor contains a dosimeter and wireless transmitter inside a sealed, biocompatible glass capsule measuring 0.8 inches (20mm) long and 0.08 inches (2.1mm) across. The transmitter uses radiofrequency technology for two-way communication with a special reader.
The DVS sensors are implanted during a minimally invasive procedure prior to starting radiation therapy. The sensor is placed 3cm beneath the surface of the skin to ensure adequate build-up, especially at higher energies and to maintain a consistent temperature.
Before and after each treatment, a radiation therapist will use a hand-held reader held above the skin near the dosimeter to transmit and report dosage information immediately to the radiation oncology team. The information alerts the team to random or systematic deviations from the prescribed dose that can have a profound impact on tumor control and surrounding normal tissue.
After Radiation Treatment
At the conclusion of radiation treatment, the DVS sensor remains in the body permanently but has no impact on everyday life. The sensors are not radioactive. The sensor will not interfere with electronic equipment (such as cell phones or computers) and although there is some metal within the device, it will not set off any airport metal detectors. The sensors are compatible with medical procedures such as mammography and MRI, but it is important to tell all healthcare providers about DVS. During a monthly breast self-exam it is possible that a person may be able to feel the dosimeter, so it is important to note the location when it is implanted. The device is durable and will not break during a regular mammogram and has not been known to break due to a blow or trauma to the breast.
Reimbursement
CMS (Centers for Medicare and Medicaid Services) has established a new HCPCS code (Healthcare Common Procedure Coding System) that became effective January 1, 2008 for implantable radiation dosimeters. This code allows for radiation therapy centers to be reimbursed for the cost of DVS as well.
Breast and Prostate Cancer
Breast cancer and prostate cancer affect a large part of the American population. Breast cancer is the leading cancer among white and African American women[1] and prostate cancer is the most common cancer amongst American men.[2] The current standard of treatment includes radiation therapy in which radiation is aimed at the tumor. One potential risk is that the radiation could also affect healthy tissue as it passes through on its way in and out of the body.[2] External beam radiation, the most widely used form of radiation, is done in breast cancer treatment five times per week for at least six weeks and in prostate cancer treatment five times per week through a period of seven to nine weeks.[2]
About Sicel Technologies
Founded in 1999 and headquartered in Morrisville, North Carolina, Sicel Technologies, Inc. is a privately held, specialty device company focused on the development of innovative therapies that significantly impact the treatment of cancer—a leading cause of death in the U.S., second only to heart disease.