Millions of people—about one-third of the adult population in the developed world— suffer from hypertension. Despite widespread efforts to better diagnose and manage hypertension, a number of factors, including the complexity of the disease, patient noncompliance with complicated drug regimens, side effects of medications and drug ineffectiveness, have resulted in poor blood pressure control rates. An increase in renal sympathetic nerve activity has been shown to be a significant contributing factor in developing and maintaining hypertensive states. It is becoming clear that the development of new, device-based therapies to perform minimally invasive renal sympathetic denervation — from catheter-based drug delivery systems to sonic and RF ablation devices — can provide a distinct advantage in combating this major healthcare burden.

Since the inception of this novel technology, CBSET has led the way in developing animal models for assessing safety, as well as quantitative methods for assessing and understanding efficacy, including biomarker assays, histomorphometry, and even computational modeling. These have been presented in international conferences and published in peer-reviewed journals, cementing CBSET’s status as a key opinion leader in the evaluation of neuroablation technologies.

Renal Denervation
CBSET has developed specialized expertise in the development and application of minimally invasive device-based interventional therapies for renal denervation.
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Seminal CBSET-authored publications related to renal denervation:

Evaluation of renal nerve morphological changes and norepinephrine levels following treatment with novel bipolar radiofrequency delivery systems in a porcine model. Cohen-Mazor M, Mathur P, Stanley JR, Mendelsohn FO, Lee H, Baird R, Zani BG, Markham PM, Rocha-Singh K. J Hypertens. 2014 May 28.

renaldenervationchartMethodological Standardization for the Pre-Clinical Evaluation of Renal Sympathetic Denervation. Sakakura K, Ladich E, Edelman ER, Markham P, Stanley JR, Keating J, Kolodgie FD, Virmani R, Joner M. JACC Cardiovasc Interv. 2014 Sep 9.

Innervation patterns may limit response to endovascular renal denervation. Tzafriri AR, Mahfoud F, Keating JH, Markham PM, Spognardi A, Wong G, Fuimaono K, Böhm M, Edelman ER. J Am Coll Cardiol. 2014 Sep 16;64(11):1079-87.

Comparison of renal artery, soft tissue, and nerve damage after irrigated versus nonirrigated radiofrequency ablation. Sakakura K, Ladich E, Fuimaono K, Grunewald D, O’Fallon P, Spognardi AM, Markham P, Otsuka F, Yahagi K, Shen K, Kolodgie FD, Joner M, Virmani R. Circ Cardiovasc Interv. 2014 Dec 31;8(1). pii: e001720. doi: 10.1161.

scitransmed-coverArterial microanatomy determines the success of energy-based renal denervation in controlling hypertension. Tzafriri AR, Keating JH, Markham PM, Spognardi AM, L Stanley JR, Wong G, Zani BG, Highsmith D, O’Fallon P, Fuimaono K, Mahfoud F, Edelman ER. Sci Transl Med. 2015 Apr 29;7(285):285ra65. doi: 10.1126/scitranslmed.aaa3236.

Renal sympathetic nerve denervation using intraluminal ultrasound within a cooling balloon preserves the arterial wall and reduces sympathetic nerve activity. Pathak A, Coleman L, Roth A, Stanley J, Bailey L, Markham P, Ewen S, Morel C, Despas F, Honton B, Senard JM, Fajadet J, Mahfoud F. EuroIntervention. 2015 Aug 22;11(4):477-84.

Anatomical and procedural determinants of catheter-based renal denervation. S Ewen; C Ukena; T Luscher; M Bergmann; P Blankestijn; B Cremers; E Blessing; O Doerr; H Nef; M Schlaich; F Sharif; MVoskuil; T Zeller; AR Tzafriri; E Edelman; M Boehm; F Mahfoud. Cardiovasc Revasc Med. 2016 Oct – Nov;17(7):474-479. doi: 10.1016/j.carrev.2016.08.004.

Anatomical and procedural determinants of ambulatory blood pressure lowering following catheter-based renal denervation using radiofrequency. Lauder L, Ewen S, Tzafriri AR, Edelman ER, Cremers B, Kulenthiran S, Ukena C, Linz D, Kindermann I, Tsioufis C, Scheller B, Böhm M, Mahfoud F. Cardiovasc Revasc Med. 2018 Mar 2. pii: S1553-8389(18)30089-7. doi: 10.1016/j.carrev.2018.02.016. [Epub ahead of print].

Renal artery anatomy assessed by quantitative analysis of selective renal artery in 1000 patients with hypertension. Lauder L, Ewen S, Tzafriri AR, Edelman ER, Lüscher TF, Blankenstijn PJ, Dörr O, Schlaich M, Sharif F, Voskuil M, Zeller T, Ukena C, Scheller B, Böhm M, Mahfoud F, EuroIntervention. 2018 Apr 10. pii: EIJ-D-18-00112. doi: 10.4244/EIJ-D-18-00112. [Epub ahead of print].