Business, neurology, urology  

Medtronic announces clinical trials strategy for neurological and urological therapies

1 May 2006

Minneapolis, USA. Medtronic, Inc. (NYSE:MDT) has announced plans to increase significantly its investment in clinical trials of the company's neurological and urological therapies. The new trials will be designed to establish higher levels of evidence for the therapies' efficacy and cost-effectiveness.

During this new fiscal year (start 1 May), Medtronic will invest in at least six new major clinical trials of therapies that use its neuromodulation or radiofrequency technology to treat a range of neurological and urological conditions. These trials will be designed to establish Class I evidence for treatments of Parkinson's disease, depression, chronic pain, severe spasticity, overactive bladder and benign prostatic hyperplasia (BPH). Ongoing trials of separate treatments for obesity and epilepsy will continue. The amount of the investments was not disclosed.

Class I evidence is defined as clinical data that demonstrates substantial benefit versus risk of a therapy for specific patient populations.

"Clinical trials that establish Class I evidence pave the way for most treatments that are recognized as standards of care," according to Dr. Richard E. Kuntz, M.D., president of the Medtronic division that includes the company's neurological and urological therapies. (Dr. Kuntz spent 15 years as a clinical trialist and interventional cardiologist before joining Medtronic.) "Our strength lies in the breadth and depth of the therapeutic technologies that we have spent decades developing. With the advent of evidence-based medicine, we must now set to work establishing the highest level of clinical evidence to ensure that more patients who can benefit from our neurological and urological therapies actually get them routinely as part of standard medical practice."

All of Medtronic's approved neurological and urological therapies have become an established part of medical practice to some degree, Dr Kuntz explained, particularly among the pioneering physician thought leaders who know the power of these therapies and their well-established safety records. To achieve acceptance by more of the mainstream medical community and bring these therapies to more people, the clinical trials strategy announced today focuses on establishing the highest level of evidence for efficacy and cost-effectiveness of current and promising indications for the division's core technologies:

  • Deep brain stimulation for the treatment of Parkinson's disease (Activa Therapy), epilepsy (Intercept Therapy) and depression.
  • Spinal cord stimulation for the treatment of chronic back and leg pain, including failed back surgery syndrome.
  • Sacral nerve stimulation (InterStim Therapy) for the treatment of overactive bladder (urinary urge incontinence and urgency frequency).
  • Transurethral needle ablation (Prostiva Therapy) for the treatment of benign prostatic hyperplasia (BPH), or enlarged prostate.
  • Intrathecal baclofen (ITB(SM) Therapy) for the treatment of severe spasticity of cerebral origin (stroke, cerebral palsy).

The trials will highlight more precise measurements of these therapies' positive impacts on patient outcomes. The results, in turn, will help physicians better determine which patients will get the most benefit from each therapy. Some of these trials will help Medtronic establish new uses for the therapies that will require regulatory approval. In other cases, the understanding of these therapies will be enhanced through stronger evidence.

"As the pioneer and leader in most of these therapeutic technologies, we believe in establishing Class I evidence to drive the treatments they deliver toward the standards of care for clearly defined patient populations," said Dr. Kuntz. "We are confident that the rigors of these trials will allow us to set the standards of proof for new indications and new technologies by which others will be judged."

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