FDA Clears New Device to Treat Malignant Lesions in the Spine

Oncology, ONCOLOGY Vol 21 No 7, Volume 21, Issue 7

Dendreon Corporation recently announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for sipuleucel-T (Provenge) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

ArthroCare, a medical device company that develops minimally invasive surgical products, announced it has received clearance from the US Food and Drug Administration (FDA) for its Cavity SpineWand to reduce malignant lesions within the vertebrae. The Cavity SpineWand is used in a minimally invasive, surgical procedure to actually remove malignant tissue within vertebrae, creating a small cavity. Medical grade cement can then be injected into the cavity, stabilizing the fracture. This procedure does not eliminate other therapeutic options for the patient such as radiation or chemotherapy.

Patented Technology

"Creating a cavity in the tumor results in better outcomes for the patient. Subsequent to reducing the tumor, cement augmentation can be used with more precise cement delivery," said Dawid Schellingerhout, md, assistant professor, diagnostic radiology at M.D. Anderson Cancer Center. "Patients who have had vertebroplasty following removal of the tumor material with the Cavity SpineWand typically report significant pain relief—sometimes even complete reduction in pain. In addition to the overall improvement of quality of life, the pain reduction and improved mobility patients experience can be instrumental in helping them comply better with chemotherapy or targeted radiotherapy treatment."

The Cavity SpineWand utilizes Coblation, a patented technology utilizing bipolar radiofrequency to gently and precisely remove soft tissue at low temperatures. An interventional neuroradiologist or neurosurgeon in consultation with a radiation oncologist, creates a small incision and inserts a cannula to access the affected area within spine. The Cavity SpineWand is inserted through the cannula under radiographic guidance and is activated once it reaches the tumor. A small, highly localized plasma cloud removes tumor material while minimizing damage to surrounding healthy tissue.