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US 11,154,712 B2Granted
Methods for assessing efficacy of renal neuromodulation and associated systems and devices
AssigneeMedtronic Ardian Luxembourg S.a.r.l.
InventorsCarol Sullivan, Stefan Tunev
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Abstract
Provided herein are methods, devices and compositions for assessing neuromodulation efficacy based on changes in the level of one or more biomarkers in plasma or urine collected from a human subject following a renal neuromodulation procedure.
Claims15
A method of assessing efficacy of a renal neuromodulation procedure in a human patient, the method comprising:
- selecting one or more biomarkers indicative of a level of sympathetic nervous activity or blood pressure from a group consisting of normetanephrine, vanillylmandelic acid, metanephrine, and homovanillic acid;
- determining a baseline level of the one or more biomarkers in urine collected from the human patient;
- at least partially inhibiting sympathetic neural activity in a renal nerve of the human patient via a neuromodulation assembly;
- determining a post-neuromodulation level of the one or more biomarkers in urine collected from the human patient;
- calculating a difference value between the post-neuromodulation level and the baseline level of the one or more biomarkers in the urine;
- and
- classifying the renal neuromodulation procedure as at least partially successful when the difference value is between a first threshold value and a second threshold value, and as completely successful when the difference value is greater than the second threshold value, wherein the first threshold value is determined from differences between post-neuromodulation levels and baseline levels achieved by patients having previously undergone partially successful renal neuromodulation, and wherein the second threshold value is determined from differences between post-neuromodulation levels and baseline levels achieved by patients having previously undergone completely successful renal modulation.
4 more elements
A method of assessing efficacy of a renal neuromodulation procedure in a human patient, the method comprising:
- selecting one or more biomarkers indicative of a level of sympathetic nervous activity or blood pressure from a group consisting of normetanephrine, vanillylmandelic acid, metanephrine, and homovanillic acid;
- determining a baseline level of the one or more biomarkers in urine collected from the human patient;
- at least partially inhibiting sympathetic neural activity in a renal nerve of the human patient via a neuromodulation assembly;
- determining a post-neuromodulation level of the one or more biomarkers in urine collected from the human patient;
- determining a difference between the post-neuromodulation level and the baseline level of the one or more biomarkers in the urine;
- and
- classifying the renal neuromodulation procedure as at least partially successful when the difference is between a first threshold amount and a second threshold amount, and as completely successful when the difference is greater than the second threshold amount, wherein the first threshold amount is based on post-neuromodulation levels and baseline levels achieved by patients having previously undergone partially successful renal neuromodulation, and wherein the second threshold amount is based on post-neuromodulation levels and baseline levels achieved by patients having previously undergone completely successful renal modulation;
- wherein the first threshold amount is based on an average of the differences between the post-neuromodulation levels and the baseline levels achieved by patients having previously undergone partially successful renal neuromodulation, wherein the second threshold amount is based on an average of the differences between the post-neuromodulation levels and the baseline levels achieved by patients having previously undergone completely successful renal neuromodulation.
5 more elements
Dependencies are inferred from the claim text.