The Visualase Thermal Therapy System and its components including the PhoTex laser, the Laser Applicator, and the MRI analysis software and workstation have all been cleared through the FDA “510(K)” pre-market notification mechanism. This means that FDA found that these components were substantially equivalent to other devices on the market and should therefore be able to be marketed for clinical use. That clearance is issued for a specific set of indications or situations for which the device is allowed to be marketed for use.
For the Visualase system, those specific indications are
- The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm.
- When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of the data at certain selected points may be monitored and/or displayed over time.
- When interpreted by a trained physician, this device provides information that may be useful in the determination of assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.
Because the Visualase thermal therapy system is an FDA-cleared medical device, your doctor is free to prescribe it for treatments when he deems it appropriate. The Visualase system is not specifically indicated for any treatment of any cancer. However, the system is indicated for the destruction of soft tissues in many types of surgery, and your doctor may decide that this type of destruction is useful for treating your tumor.
More information on brain cancer and brain tumor treatment
Treatments are indicated to help stop tumor growth, shrink brain tumors, or reduce the tumor mass. Some treatments remove tumor growth or cancer cells surgically, others attack the cells with radiation. Another option is to heat up the tumor tissue until it’s destroyed. There is no brain cancer treatment that can claim to be a cure for brain cancer. Cancer can show recurring growth or new growth at any point, regardless of what treatment or combination of treatments have been used. There is no cure for cancer. Cancer is a systemic disease – it affects the whole body or many organs – and the result could be a cancerous growth in the brain. Brain cancer treatment really refers to brain tumor (cancerous brain tumor or malignant brain tumor) treatment, which is intended to stop or remove growth of cancer cells in the brain to provide a better quality of life for the patient.
More information regarding The Visualase thermal therapy system.
For more information on the FDA regulatory statutes and the 510(k) process, visit www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
For more information regarding the use of this site please visit our Terms Of Use page.
This website is not intended as a substitute for the diagnosis, treatment and advice of a qualified licensed professional.
The Visualase Thermal Therapy System and its components including the PhoTex laser, the Laser Applicator, and the MRI analysis software and workstation have all been cleared through the FDA “510(k)†pre-market notification mechanism. This means that FDA found that these components were substantially equivalent to other devices on the market and should therefore be able to be marketed for clinical use. That clearance is issued for a specific set of “indications†or situations for which the device is allowed to be marketed for use. For the Visualase system, those specific indications are: “The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of the data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination of assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.†Because the Visualase thermal therapy system is an FDA-cleared medical device, your doctor is free to prescribe it for treatments when he deems it appropriate. The Visualase system is not specifically indicated for any treatment of any cancer. However, the system is indicated for the destruction of soft tissues in many types of surgery, and your doctor may decide that this type of destruction is useful for treating your tumor. More information regarding The Visualase thermal therapy system. Some treatments help stop tumor growth, even shrink brain tumors. Other treatments remove tumor growth or cancer cells surgically. Another option is to heat up the tumor tissue until it's destroyed. There is no brain cancer treatment that can claim to be a cure for brain cancer. Cancer can show recurring growth or new growth at any point, regardless of what treatment or combination of treatments has been used. There is no cure for cancer. Cancer is a systemic disease - it affects the whole body or many organs - and the result could be a cancerous growth in the brain. Brain cancer treatment really refers to brain tumor (cancerous brain tumor or malignant brain tumor) treatment, which is intended to stop or remove growth of cancer cells in the brain to provide a better quality of life for the patient. This website is not intended as a substitute for the diagnosis, treatment and advice of a qualified licensed professional. For more information on the FDA regulatory statutes and the 510(k) process, go here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm For more information regarding the use of this site please visit our Terms Of Use page.
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