New minimally invasive procedure touted for lower back, leg pain associated with bulging or herniated disks
Smith & Nephew has introduced a decompression catheter, an ElectroThermal or heat-based procedure for lower back and leg pain associated with bulging or contained herniated disks. Each year, approximately 6 million Americans make new visits to physicians for back pain and nearly 500,000 require hospitalization. In addition, industry studies estimate that direct medical costs for lower back pain are roughly $24 billion, with an additional $30 to $40 billion resulting from such indirect costs as lost work time and workers' compensation.
Gunnar Andersson, MD, professor and chairman of orthopedic surgery at Rush-Presbyterian-St. Luke's Medical Center in Chicago, said, “Unlike invasive and other spinal decompression treatments that simply heat nuclear tissue within the center of the spinal disk, the Smith & Nephew Decompression Catheter uses thermal energy to direct heat at the physical site of pathology. For patients living and suffering with debilitating back pain associated with a bulging or contained herniated disk, this new procedure may help them regain an active lifestyle.”
Prescribed for symptomatic patients who have failed conservative treatments, such as physical therapy, medication, and rest, the decompression procedure uses scientifically validated thermal technology to modify nuclear tissue and relieve the pressure the herniation was creating on the spinal nerve root. The procedure is performed on an outpatient basis with the patient under local anesthesia.
For details, visit www.smith-nephew.com or www.endoscopy1.com.
Newly FDA-approved laser therapy is alternative for carpal tunnel syndrome
A new noninvasive low-level laser called the ML830 has received Food and Drug Administration (FDA) market clearance. Its use can improve the symptoms of carpal tunnel syndrome (CTS), reducing the need for surgery. CTS is a chief complaint among people with major disabling workplace injuries and illnesses.
Distributed by Laser Therapeutic Technology Inc, the ML830 laser is a nonthermal laser capable of penetrating deep into tissue. Once delivered, the light energy promotes photobiostimulation, which reduces pain, inflammation, edema, and healing time.
The laser is a portable, hand-held, battery-operated low-level energy laser. Treatments typically last 15 to 20 minutes and are delivered 3 times a week over a 5-week period. Treatment lengths may vary. Currently, more than 300 medical doctors, chiropractors, and physical therapists use the therapy to treat CTS, a stress-related injury whereby repetitive hand movement causes tendons in the hand and wrist to swell and press on a nerve.
For additional information, call (800) 235-3540 or email sales@laserhealing.com.
FDA clears radiofrequency ablation technology for pain relief from bone tumors
The FDA has cleared RITA Medical Systems Inc (www.ritamedical.com) to market its proprietary radiofrequency (RF) ablation technology to provide patients who have cancer with relief from the pain that often occurs when cancer spreads to the bone. The FDA clearance follows a clinical study of the system's effectiveness at 9 medical centers in the United States and Europe. The study, led by a team of physicians at Mayo Clinic, showed that 95% of the patients treated with the RF procedure experienced a clinically significant reduction in pain from bone tumors.
The most common site of cancer spread is the bone, and as many as 50% of patients with this condition have debilitating pain that is not adequately relieved by any conventional means. The 43-patient study demonstrated that the RF system offered rapid and durable pain relief. Patients were asked to report their pain on a standard 10-point pain rating scale before and after the procedure with 10 being pain “as bad as you can imagine.” Of the 43 patients, 41 experienced a clinically significant reduction in the severity of their pain after a single treatment. Most of these patients reported significant pain relief within the first week after their treatment and said the relief increased in subsequent weeks. More than 75% of patients experienced 90% or more pain relief at some point during the study. Follow-up on these patients indicates they continue to enjoy significant pain relief up to 6 months after their RF treatment.
The system enables physicians to deliver RF energy into the tumor tissue through an array of thin electrodes that heat and effectively destroy or ablate the targeted tissue. In many cases, this minimally invasive procedure can be performed in an outpatient setting or with an overnight stay.
For further information, contact RITA CFO Don Stewart at (650) 314-3400 or Mary Lawson of Mayo Clinic at (507) 266-0810.
Patented method could overcome drug resistance in cancer and infectious diseases
Immunomedics Inc has been granted a patent for its treatment method that uses conjugated polyspecific antibodies, or antibodies that bind to more than 1 target, so that both the multidrug resistance gene product and the antigens associated with the particular cancer or infectious agent can be targeted. The potential conjugates also include drugs, toxins, radioisotopes, immunomodulators, photoactive agents, or dyes, which can be targeted to the cancer cells or infectious agents for selective therapy.
Drug resistance is a major obstacle to the successful treatment of many cancers and infections, both bacterial and parasitic. One important mechanism responsible for this resistance is related to the increased expression of certain proteins by the resistant cells, such as P-glycoprotein. P-glycoprotein and related molecules are responsible for cancer cells or microorganisms pumping out the drugs that constitute many of the conventional chemotherapy agents, giving rise to multidrug resistance (MDR), which results in a cross-resistance to many drugs affected by MDR.
By constructing conjugated polyspecific antibodies, which target both the MDR protein and the cancer cells or infectious agents, MDR may be selectively blocked. This method may allow the cancer cells to be susceptible to the common drugs affected by MDR, whereas the normal cells having MDR are unaffected and thus protected from the drugs.
For details, visit www.immunomedics.com.
Brain aneurysm trial halted after less-invasive treatment is proved superior to invasive surgery
Results from the International Subarachnoid Aneurysm Trial (ISAT) demonstrate that less-invasive endovascular treatment with detachable platinum coils produces better outcomes for patients suffering from ruptured brain aneurysms than neurosurgical clipping. Published in The Lancet, the study showed that the risk of death or significant disability at 1 year for patients treated endovascularly with coils was 22.6% lower than for those treated neurosurgically with clipping. Results from interim analysis of the data were so compelling that the trial was halted early after enrolling 2143 of the planned 2500 patients because the trial steering committee decided it was no longer ethical to randomize patients to neurosurgical clipping.
The only multicenter, prospective, randomized trial comparing endovascular coiling of ruptured brain aneurysms to neurosurgical clipping, ISAT demonstrated that, in patients equally suited for either treatment, coiling provides better outcomes in terms of survival free of disability for 1 year.
An estimated 18 million people in the United States will develop a brain aneurysm during their lifetime. Every year more than 30,000 people have ruptured brain aneurysms. Ten percent to 15% of these patients die before reaching the hospital; more than 50% die within 30 days after rupture. Of those who survive, approximately half have some permanent neurologic deficit.
Health care analysts suggest that as many as 75% of U.S. patients with brain aneurysms are treated by neurosurgical clipping, which involves removing a section of the skull and placing a surgical clip at the neck of the aneurysm. Endovascular treatment, introduced in the early 1990s, involves inserting a catheter into the femoral artery in the patient's leg and navigating it through the vascular system under radiographic guidance into the head and the aneurysm. Tiny platinum coils then are threaded through the catheter and deployed into the aneurysm, obstructing blood flow into the aneurysm and preventing further damage.
Investigators said patients had to be suitable for both treatments to be included in the trial, and once in the trial, they were systematically randomized so that the 2 treatment arms were comparable in terms of age, gender, patient condition, and aneurysm location.
Funded by the Medical Research Council of Great Britain in 1997, ISAT systematically compared endovascular coiling with neurosurgical clipping. Forty-three neurosurgical centers in Europe, North America, and Australia participated, enrolling patients who were deemed suitable for either treatment.
For details, visit www.bsci.com.
Parkinson's disease treatment study
CHICAGO—A small but promising study found that an over-the-counter dietary supplement may slow the progression of Parkinson's disease (PD). Existing treatments may ease symptoms of the degenerative brain disorder but are not believed to affect the underlying disease process.
The new study found evidence that a naturally occurring compound called Coenzyme Q-10, or CoQ10, may help stop the nerve cell death that characterizes PD. The study involved 80 people. Half of the group ate maple-nut flavored wafers containing various CoQ10 doses, whereas the other half took a placebo for as many as 15 months. By the study's end, 23 patients on the highest daily doses had 44% less decline in mental function, movement, and ability to perform daily living tasks than the placebo group. The results of this study appeared in October's Archives of Neurology.
Lead author of the study, Dr. Clifford Shults at the University of California at San Diego, and colleagues caution that there is not enough proof to recommend that patients with PD use the supplements, which are sold over the counter as antioxidants that purportedly help improve heart function.
PD is a progressive disorder that affects about 500,000 Americans. It results from degeneration of nerve cells that produce a neurotransmitter called dopamine, which is necessary for muscle control.
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