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The Procedural and Anatomical Determinants of Second-generation Renal Denervation Therapy Are Explained by Local Tissue Anatomy, Suggesting a New Paradigm for Treatment Optimization: CBSET Data Published in Hypertension

12:34 EDT 15 Aug 2019 | Businesswire

“The combination of quantitative preclinical experiments and computational models have expanded our understanding of the mechanisms that facilitate circumferential nerve ablation and clinical efficacy. These data help complete the puzzle for device innovators, and aid in the advancement of specific approaches to treat diseases involving sympathetic denervation and modulation,” said Peter M. Markham, President and CEO, CBSET.

CBSET Inc., a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today that its scientists have published data and analyses (“Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy”) that provide critical insights into the interplay between target anatomy and device attributes in determining treatment success of catheter-based renal denervation (RDN) therapy.

These data suggest that delivery of at least 4 successful ablations may assure efficacy and are published in the September issue of Hypertension, a publication of the American Heart Association (AHA).

“Catheter-based renal denervation is under investigation for treatment of hypertension, with mixed results. The published data have demonstrated that large arterial diameter and anatomical heat which sinks along the length and circumference of the renal artery can limit the efficacy of ablation therapies in the treatment of hypertension. These data increase our insight into the connection between target anatomy and patient efficacy post-renal denervation by single and multiple RF electrode catheters,” said Dr. Felix Mahfoud, M.D., Department of Internal Medicine III, Saarland University, Homburg/Saar, Germany, co-author and EuroPCR co-course director.

“Clinical data have suggested that delivery of four-quadrant ablation is necessary for RDN efficacy, but it remained unclear how to reliably achieve this goal without recourse to an excessive number of arterial ablations. Our finding of a predictive dependence of renal norepinephrine on the percentage of ablated nerves in treated porcine arteries allowed us to definite the dependence of ablation efficacy on the number and spatial distribution of ablating electrodes. Moreover, experimental and computational studies further revealed that efficacy is limited by the diameter of the treated arteries and the proximity of microanatomic heat sinks near ablation sites. The current device therapies are still in their infancy, and the rate of technological advancement in this field is accelerating exponentially. These preclinical data help explain the prior clinical variability documented following renal denervation in humans and provide a quantitative framework for optimization of novel sympathetic denervation therapies,” said CBSET Director of Research and Innovation Dr. Rami Tzafriri, Ph.D., lead author of the published study.

“Mechanistic insight bridges the preclinical and clinical experiences and is ultimately the only effective means of resolving seeming conflicts or disparities in observations. CBSET’s groundbreaking work in renal denervation has provided the precision needed to produce a coherent paradigm by which to appreciate this complex field. The systematic integration of quantitative computational-modeling with rigorous preclinical evaluation has now created a framework by which to optimize the potential of sympathetic denervation and modulation as a treatment modality,” added Elazer Edelman, M.D., Ph.D., chairman and co-founder of CBSET, and senior author on the paper.

For more information about CBSET, contact Michael Naimark, Director of Business Development: +1-781-541-5627, mnaimark@cbset.org

About CBSET
CBSET Inc. — 500 Shire Way, Lexington, Mass. — is the preclinical research leader in critically important therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services or please contact us.

Ronald Trahan, President, Ronald Trahan Associates Inc., 508-359-4005, x108; rtrahan@ronaldtrahan.com

 

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