FIRM'S SPINAL IMPLANT WINS OK DEVICE DESIGNED TO BE RECHARGED.Byline: Patricia Farrell Aidem Staff Writer VALENCIA - A Valencia biotechnology firm won FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval this week of a spinal implant to treat chronic back and leg pain that can be recharged, significant because existing implants must be surgically replaced as often as every year, a company spokesman said Thursday. Advanced Bionics' new spinal cord spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column. stimulation system is expected on the market by summer, giving the company time to build its supply after getting the go-ahead Tuesday from the U.S. Food and Drug Administration, company and federal FDA officials said. The price tag is a staggering $40,000, Lynch said, adding that most insurances companies cover the treatment for patients suffering chronic pain, often related to failed back surgeries. ``It a device to treat debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction chronic back pain. It's for individuals with horrendous back pain who have tried various treatments from medication, over-the-counter or prescribed, to physical therapy,'' Lynch said. ``It's that last straw last straw n. The last of a series of annoyances or disappointments that leads one to a final loss of patience, temper, trust, or hope. [ when there's nothing left.'' Such implants work by delivering an electrical current to the spinal cord to block pain signals heading to the brain, Lynch said. ``What's unique about this device is it's rechargeable,'' Lynch said. ``Others that are not rechargeable, when they lose their power, they have to be surgically removed and replaced after 12 to 24 months. We expect this to last significantly longer, for more than five years. That reduces the number of repetitive surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. and reduces the financial impact.'' The new device, half the size of previous implants, is implanted in the lower back or buttock but·tock n. 1. Either of the two rounded prominences on the human torso that are posterior to the hips and formed by the gluteal muscles and underlying structures. 2. buttocks The rear pelvic area of the human body. , depending on the source of pain and the patient's lifestyle. A small remote recharger is held against the site of the implant, carrying a radio frequency signal that reboots it, Lynch said. It also can be programmed by the patient to better target pain. The new system, with twice the number of electrodes as other implants, is helpful to surgeons because it better involves patients in their treatment, said Dr. John Oakley John Oakley is a radio talk show host in Toronto, Ontario. He is currently working at the AM640 Toronto Radio station in the 5:30am-10am time slot. External links
``Patients can use this device for a very long time before it needs to be replaced,'' Oakley said. ``More importantly, patients can be directly involved with their programming so stimulation can be steered to the precise neural population we need to target.'' Advanced Bionics, led by technology giant Alfred E. Mann Alfred E. Mann (born 1925, Portland, OR), who is also known as Al Mann, is an American entrepreneur and philanthropist. He is a billionaire. Born and raised in Portland, his father was English and mother Polish. , is headquartered in Valencia, with its manufacturing plan in Sylmar. Founded in 1993, the company's focus is on bionic A machine that is patterned after principles found in humans or nature; for example, robots. It also refers to artificial devices implanted into humans replacing or extending normal human functions. See biomimicry. devices for people with neurological disorders. Patricia Farrell Aidem, (661) 257-5251 pat.aidem(at)dailynews.com CAPTION(S): 2 photos Photo: (1 -- color) Doug Lynch, marketing director for Advanced Bionics in Valencia, holds a small implant, called a spinal cord stimulation system, that helps eliminate chronic back pain. David Crane/Staff Photographer (2) This composite photo shows how the spinal cord stimulation system is implanted into a patient's body. |
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