Difference between revisions of "NovoTTF-100A system (Optune)"

Revision as of 12:22, 24 November 2015

General information

Class/mechanism: External portable device which delivers electric tumor treating fields (TTFields) via insulated transducer arrays placed on the patient's skin close to glioblastoma multiforme (GBM) tumors. TTFields affect dividing cells by two main mechanisms. First, they disrupt microtubule spindle formation during anaphase, in which tubulin, a highly electrically polar molecule, normally forms polymers. Exposure to TTFields prevents tubulin from being able to align properly and promotes depolymerization of mitotic spindles. Second, the TTFields disrupt the cleavage plane between the two daughter cells during late telophase. These actions halt cell division, cause abnormal spindle formation, disrupt regular chromosome separation, and result in apoptosis.^[1]^[2]^[3]^[4]^[5]^[6]^[7]
Route: external portable device
Extravasation: n/a

Patient drug information

History of changes in FDA indication

4/8/2011: FDA approved "to treat adults with glioblastoma multiforme (GBM) that recurs or progresses after receiving chemotherapy and radiation therapy."^[10]
10/5/2015: FDA approved expanded indication "as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM)...for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy."

Also known as

NovoTTF-100A device, PMA P100034/S013

References

[insert-1] NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED)

[2] NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED) (locally hosted backup)

[3] NovoTTF-100A FDA neurological device information

[4] NovoTTF-100A FDA neurological device information (locally hosted backup)

[5] NovoTTF-100A manufacturer's website

[6] FDA medical device page

[7] Optune manufacturer's website

[8] NovoTTF-100A device (Optune) instructions for use

[9] NovoTTF-100A FDA neurological device information PDF pages 208-259

[10] NovoTTF-100A system FDA overview of information

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[2]

[3]

[4]

[5]

[6]

[7]

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-Also known as the NovoTTF-100A System.
 ==General information==
-Class/mechanism: External portable device which delivers electric tumor treating fields (TTFields) via insulated transducer arrays placed on the patient's skin close to glioblastoma multiforme (GBM) tumors.  TTFields affect dividing cells by two main mechanisms.  First, they disrupt microtubule spindle formation during anaphase, in which tubulin, a highly electrically polar molecule, normally forms polymers.  Exposure to TTFields prevents tubulin from being able to align properly and promotes depolymerization of mitotic spindles.  Second, the TTFields disrupt the cleavage plane between the two daughter cells during late telophase.  These actions halt cell division, cause abnormal spindle formation, disrupt regular chromosome separation, and result in apoptosis.<ref name="insert">[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247168.pdf NovoTTF-100A FDA neurological device information]</ref><ref>[http://hemonc.org/docs/packageinsert/novottf.pdf NovoTTF-100A FDA neurological device information (locally hosted backup)]</ref><ref>[http://www.novocure.com/ttf_therapy.php?ID=16 NovoTTF-100A manufacturer's website]</ref><ref>[http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm254480.htm FDA medical device page]</ref>
+Class/mechanism: External portable device which delivers electric tumor treating fields (TTFields) via insulated transducer arrays placed on the patient's skin close to glioblastoma multiforme (GBM) tumors.  TTFields affect dividing cells by two main mechanisms.  First, they disrupt microtubule spindle formation during anaphase, in which tubulin, a highly electrically polar molecule, normally forms polymers.  Exposure to TTFields prevents tubulin from being able to align properly and promotes depolymerization of mitotic spindles.  Second, the TTFields disrupt the cleavage plane between the two daughter cells during late telophase.  These actions halt cell division, cause abnormal spindle formation, disrupt regular chromosome separation, and result in apoptosis.<ref name="insert">[http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100034S013b.pdf NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED)]</ref><ref>[[Media:Novottf SSED.pdf | NovoTTF-100A system (Optune) FDA summary of safety and effectiveness data (SSED) (locally hosted backup)]]</ref><ref>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247168.pdf NovoTTF-100A FDA neurological device information]</ref><ref>[[Media:Novottf.pdf | NovoTTF-100A FDA neurological device information (locally hosted backup)]]</ref><ref>[http://www.novocure.com/ttf_therapy.php?ID=16 NovoTTF-100A manufacturer's website]</ref><ref>[http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm254480.htm FDA medical device page]</ref><ref>[http://www.optune.com/ Optune manufacturer's website]</ref>
 <br>Route: external portable device
 <br>Extravasation: n/a
 ==Patient drug information==
+*[http://www.optune.com/Content/pdfs/Optune_IFU_8.5x11.pdf NovoTTF-100A device (Optune) instructions for use]<ref>[http://www.optune.com/Content/pdfs/Optune_IFU_8.5x11.pdf NovoTTF-100A device (Optune) instructions for use]</ref>
 *[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247168.pdf#page=208 NovoTTF-100A FDA neurological device information PDF pages 208-259]<ref>[http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247168.pdf#page=208 NovoTTF-100A FDA neurological device information PDF pages 208-259]</ref>
+==History of changes in FDA indication==
+*4/8/2011: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm251669.htm FDA approved] "to treat adults with [[Central nervous system (CNS) cancer|glioblastoma multiforme (GBM)]] that recurs or progresses after receiving chemotherapy and radiation therapy."<ref>[http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm254480.htm NovoTTF-100A system FDA overview of information]</ref>
+*10/5/2015: [http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465744.htm FDA approved expanded indication] "as a treatment for adult patients (22 years of age or older) with histologically-confirmed [[Central nervous system (CNS) cancer|glioblastoma multiforme (GBM)]]...for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy."
+==Also known as==
+NovoTTF-100A device, PMA P100034/S013
 ==References==
 <references/>