Press Release: Clinical Efficacy of Renal Denervation Therapies is Related to Innervation Patterns, Microanatomical Structures, and Treatment Paradigms: CBSET to Present Further Mechanistic Evidence at ‘TCT 2014’

“Confounding data from recent clinical trials must not deter industry. Sympathetic denervation and neuromodulation techniques still provide an exciting opportunity for the treatment of resistant hypertension and of a variety of other diseases. The current device therapies are still in their infancy, and the rate of technological advancement in this field is accelerating exponentially.Our preclinical data helps explain the prior clinical variability and will ultimately enhance the clinical performance of the future generation of neuromodulation therapies.” – Peter M. Markham, President and CEO, CBSET

LEXINGTON, Mass., Sept 11, 2014 — Though a large body of scientific research has convincingly demonstrated the link between sympathetic activity and drug-resistant hypertension, catheter-based renal denervation has been confounded by unreliable efficacy in large patient populations. Scientists at CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, will present data at ‘TCT 2014’ demonstrating that anatomical asymmetries along the length and circumference of the renal artery can limit the efficacy of ablation therapies in the treatment of drug-resistant hypertension. These data increase CBSET’s insight into the connection between target anatomy and patient efficacy post-renal denervation by single and multiple RF electrode catheters.

Dr. Rami Tzafriri, Principal Scientist and computational modeling expert at CBSET, will present: “Renal Norepinephrine Reduction Following Radiofrequency Renal Denervation Correlates with Extent of Nerve Ablation: Roles of Ablation Areas, Anatomy, and Number of Treatments”, on Saturday, Sept. 13, 2:40 p.m. ET. Dr. Tzafriri will also present the poster “Innervation Patterns in the Renal Artery Ostium May Limit the Efficacy of Endovascular Radiofrequency Ablation” on Saturday, Sept. 13, 5:00-7:00 pm.

“While past work has highlighted the importance of ablation depth, our analysis of nerve distribution patterns and other anatomical features highlights the importance of the extent of circumferential ablation to adequately treat a threshold of nerves. This implies that controlled location of multiple RF treatments can optimize efficacy. Our use of quantitative experiments and computational models can explain variable ablation effects by accounting for variability in nerve location and size, compounded by variability in ablation location and geometry. The additive biomarker effects seen with helically staggered treatment protocols can be leveraged to optimize device design (e.g. electrode number and spacing) and treatment protocols (e.g. energy and treatment location) in the face of unknown variable microanatomy,” said Peter Markham, President, CEO and co-founder of CBSET.

“CBSET has expanded our scientific knowledge of the underlying the mechanisms that stimulate more efficacious renal denervation therapy in preclinical models. As a result, the CBSET data and quantitative experimental-computational framework are an essential roadmap for industry to understand and optimize their product development efforts in treating diseases involving sympathetic denervation and modulation,” added Elazer Edelman, M.D., Ph.D., chairman and co-founder of CBSET and senior author of the presentation.

“The CBSET scientific findings are not only a boon for renal denervation innovators, but to the entire emerging therapeutic field of catheter-based modulation of sympathetic tone. Indeed, heart failure, metabolic disease, obstructive sleep apnea and other disorders involving the sympathetic nervous system may eventually profit from this seminal research,” said Dr. Erica Smith, Director, Business Development at CBSET.

To learn more about this study and the services provided by CBSET, contact Dr. Erica Smith, Director of Business Development at CBSET: +1-781-296-5319,


CBSET Inc. — 500 Shire Way, Lexington, MA 02421 — 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.