A Case for Foundational Understanding of MACRO-Level Disease Dynamics
Following the publication of the initial Symplicity studies several years ago, the medtech community met the emergence of renal denervation for treatment of drug resistant hypertension with excitement and optimism. Those initial studies demonstrated significant reductions in blood pressure among those taking greater than three antihypertensive medications. However, the third-phase trial results showed no significant difference in blood pressure reduction between the treatment and sham arms. Why? What changed from trial to trial?
A lack of understanding about population level disease dynamics likely was a major factor. This white paper shares insight on the critical importance of population level disease dynamics, and how they inform patient selection and clinical trial design, define market opportunity and ultimately help determine an emerging technology’s full market potential.