Medtronic announces clinical trials strategy for neurological and
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
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
Class I evidence is defined as clinical data that demonstrates
substantial benefit versus risk of a therapy for specific patient
"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
- 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."