Cancer hurts. Particularly when primary cancers spread to the spine and tumors develop. They can weaken vertebral bone, cause debilitating pain, impaired mobility and increased reliance on drug therapy.
All of this can sabotage chemotherapy or radiation therapies.
A company that's developed products based on Coblation therapy, ArthroCare (Austin, Texas) has had a year since FDA approval of its Cavity SpineWand, (Medical Device Daily, May 30, 2007) to get a feel for the real impact of its tool to rid cancer survivors of painful spine tumors. More than 400 patients have been treated to date.
"This is a palliative treatment," Jim Pacek, VP and general manager of ArthroCare's Interventional Therapies division told MDD. "We're not treating cancer. These patients they have metastatic disease. When it gets inside a vertebrae, it eats away the bone.
"The job of this device is to debulk the tumor and then follow up with cement procedure, stabilizing the fracture. The prospects of Coblation-based products specifically developed for metastatic lesions should help patients with their quality of life and with their continued treatment and care."
Some 30% to 70% of the more than half-million people who die annually of cancer have skeletal metastases, and 10% of the 700,000 vertebral compression fractures that occur each year are believed to be caused by metastatic spine tumors, according to the American Cancer Society (Atlanta).
Pacek explained that the 8-gauge and 11-gauge SpineWands are used in minimally invasive procedures. The SpineWand, featuring a "bouquet" of electrodes at the tip, is put down a cannula to access the inside of the vertebrae via a tiny incision during the outpatient procedure. Once inside, the device is attached to a controller.
"The electrodes," Pacek said, "are activated to form a micro-cloud of plasma that dissolves the tumor."
Coblation uses bipolar radio frequency to gently remove soft tissue at low temperatures, generally 40 degrees to 70 degrees Celsius.
"We enjoy a unique space in this market," Pacek said.
Another treatment for spine tumors is kyphoplasty, a technique developed by Kyphon (Sunnyvale, California), in which bone cement is injected directly into the fractured bone to stabilizes the fracture and provides immediate pain relief. "In kyphoplasty you displace tissue and where does it go? With our procedure, we are excavating tissue," Pacek said.
One of the patients treated with the SpineWand is Theresa Fox (Marlette, Michigan).
The 35-year-old, an active equestrian, was diagnosed with cervical cancer in 2005 and then was treated with chemotherapy. She went into remission for more than a year.
But in early 2007, she began experiencing back pain. Painkillers had little impact, which forced her to give up riding, and ultimately, her job. An MRI revealed that her cervical cancer had spread to her lung and spine, causing a spine tumor that had fractured her vertebrae.
Later in the year Fox was treated using the Cavity SpineWand, followed by vertebroplasty performed by Bhrat Mehta, MD, interventional radiologist at Hurley Medical Center (Flint, Michigan). After treatment, she was able to return home the following day and reduce her usage of pain killers within a week.
"This was the easiest procedure for me that I have gone through," Fox said, "and was able to do so much that, within a week, I was able to sleep through the night in my own bed."
Typically, vertebral compression fractures (VCF) are diagnosed only after a person seeks medical help for pain relief or after a fall. Patients who experience a VCF as a result of a spinal tumor may think the associated pain is due to the cancer itself or its treatment rather than a fracture and may not seek diagnosis or treatment.
"We don't take anything off the table in terms of cancer treatment," Pacek said. "All of the traditional therapies are still an option for the patient. We do think sometimes sequencing our therapy before radiation or chemotherapy works best. We've had reports from oncologists who say that by doing the treatment earlier in care, they have a patient in less pain and they can lay flat on table and be in greater comfort for cancer therapies."
Given its initial success, ArthroCare has initiated a program to focus Coblation technology to treat patients suffering from metastatic disease in other major weight-bearing, structural bones, such as the pelvis and femur and when fractured, complicate treatment options for patients with cancer.
It is estimated that 500,000 patients with metastatic disease will develop lesions in structural bones that may benefit from treatment. Traditional treatment options for these patients include radiation, chemotherapy and reconstructive surgery which in late stages can include amputation.
"Next, we will go through the regulatory pathways to get approval outside the vertebrae," Pacek said of the $2,400 SpineWand.
SpineWand is already approved in Europe, Australia, Central and South America, New Zealand and Singapore.
(Editor's note: Less happy developments for Arthrocare appear in today's Court report column, p. 5.)