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THERAPY

The initial focus of the PARADISE™ technology is for treating patients with Resistant Hypertension.

Hypertension is a major public health burden, present in more than one quarter of adults in developed societies and associated with reduced life expectancy and increased risk for cardiovascular disease, including myocardial infarction, stroke, and heart failure.1

The primary treatments for hypertension are lifestyle modification and antihypertensive medication, typically with drugs from at least 2 classes. However, hypertension remains uncontrolled in more than 50% of patients in the United States and even higher rates in Europe.

While uncontrolled hypertension may be caused by factors such as inadequate treatment regimen or poor medication adherence,2 a significant subset of patients are truly non-responsive to conventional therapy, a condition known as resistant (or refractory) hypertension.

The European Society of Hypertension defines resistant hypertension as blood pressure that remains above goal despite treatment with a therapeutic plan that has included attention to lifestyle measures and the prescription of at least three drugs (including a diuretic) in adequate doses.3 Resistant hypertension has been estimated to affect 15% to 30% of participants in clinical trials of antihypertensive medication and 5% to 30% of patients in clinical practice.

The etiology of resistant hypertension is likely multifactorial. However, animal studies and subsequent studies in humans have demonstrated that the sympathetic nervous system, in particular afferent and efferent sympathetic nerves from and to the kidneys, plays an important role in blood pressure regulation and the pathophysiology of hypertension. In certain patient subsets, hyperactivity of the afferent and efferent sympathetic nerves in the renal artery walls may be the primary mechanism by which the kidneys contribute to systemic hypertension.

In an attempt to reduce this hyperactivity, catheter-based renal denervation has emerged as a safe and effective method for selectively damaging the sympathetic nerves, resulting in a sustained blood pressure reduction.

In response to the need for a uniform and efficient method to perform renal denervation, PARADISE™ was born.

ReCor has conducted significant pre-clinical work in the swine model. Renal denervation performed using the PARADISE™ system in the swine model showed the following:

  • Consistent energy delivery within the renal artery and proven impact of denervation
  • Minimal endothelial damage due to cooling with low-pressure balloon
  • Safety out to 6 months
  • Statistically significant norepinephrine reduction

ReCor is currently completing the REDUCE (First-In-Man) study which is already showing clinically relevant blood pressure reductions in patients with resistant hypertension out to 3 months.

PARADISE™ received CE mark for 2nd generation in Q4 2012 and a post market study is underway in multiple European Countries.






Citations:

  1. Wolf-Maier K, Cooper RS, Kramer H, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension. Jan 2004;43(1):10-17.
  2. Calhoun DA, Jones D, Textor S, et al. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. Jun 24 2008;117(25):e510-526.
  3. Mancia G, De Backer G, Dominiczak A, et al. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. Jun 2007;25(6):1105-1187.