COVER STORY
This past spring, Medtronic Inc. (Minneapolis) announced plans to significantly boost its investment in clinical trials for the company's neurological therapies. Throughout Medtronic's fiscal 2007, which began in May, the company plans to invest in at least six new major clinical trials. The trials are being designed to establish Class I evidence for treatments using the company's neuromodulation or radio-frequency (RF) technologies.
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InterStim therapy has been referred to by physicians as 'a pacemaker for the bladder'.
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Each new trial will be designed to establish higher levels of evidence for the therapies' efficacy and cost-effectiveness. "Recently device companies, including Medtronic, have started placing an emphasis on gathering data related to cost during clinical trials," says Richard E. Kuntz, MD, president of Medtronic's neurological division. "That new emphasis is being driven by societal demands. Medtronic wants to continue to demonstrate that its devices are worthy of their price."
According to Medtronic, some of its trials will help the company establish new uses for its devices, and will require regulatory approval. In other cases, Medtronic looks to enhance the understanding of certain therapies through stronger evidence. The trials will focus on current and promising indications for the division's core technologies, including the following.
Deep brain stimulation for the treatment of Parkinson's disease via Activa therapy. Activa therapy uses an implanted device, similar to a cardiac pacemaker, to deliver controlled electrical stimulation to targeted areas within the brain. To date, more than 30,000 people worldwide have been treated with Activa therapy.
Deep brain stimulation for epilepsy via the Intercept epilepsy control system, which is currently undergoing clinical study involving approximately 150 patients at about 15 sites in the United States and Canada. The trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy.
Spinal cord stimulation for the treatment of chronic back and leg pain, including failed back surgery syndrome.
Sacral nerve stimulation via InterStim therapy for the treatment of overactive bladder. Referred to by physicians as 'a pacemaker for the bladder,' InterStim therapy helps control urinary problems through an implanted device that sends mild electrical impulses via a lead to the sacral nerves that control the bladder, sphincter, and pelvic floor muscles.
Intrathecal baclofen (ITB) therapy for the treatment of severe spasticity of cerebral origin. Medtronic ITB therapy delivers a liquid form of baclofen directly into the intrathecal space, where fluid flows around the spinal cord. ITB therapy may relieve severe spasticity with small amounts of baclofen delivered via a programmable pump that is surgically placed and connected to a catheter in the body.
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