During its next fiscal year Medtronic will invest in at least six new major clinical trials of therapies that use its neuromodulation or radio-frequency 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,” said Dr Richard Kuntz, president of the Medtronic division that includes the company’s neurological and urological therapies. “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.”