“We will report a breakthrough: an experimental computational methodology for understanding and predicting lesion geometry following radiofrequency (RF) renal denervation treatment to lower hypertension. We expect that our research will have a significant effect on the development of devices that will be able to more precisely and selectively deliver RF or other types of energy to the nerve-rich tissue compartments surrounding the renal artery wall” – Peter M. Markham, President and CEO, CBSET
LEXINGTON, Mass., Oct 23, 2013 — CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, will present data from the podium at the ‘TCT 2013’ (Transcatheter Cardiovascular Therapeutics) annual scientific meeting that provides a seminal experimental and computational template for a more rational, comprehensive preclinical evaluation and optimization of renal denervation devices.
The data—“Electrode irrigation alters RF ablation treatment zone geometry and protects intimal and medial tissue while maintaining injury to renal nerves”—will be presented by Elazer Edelman, M.D., Ph.D.*
“Although the anti-hypertensive drug market is $18 billion annually, about half of hypertensive patients who are on drug therapy do not achieve adequate control of their blood pressure. Therefore the door is wide open for effective hypertension therapies in this population, such as renal denervation devices,” said Peter Markham, president, CEO and a co-founder of CBSET. “By coupling quantification of the efficacy biomarker of renal denervation—NEPI, or norepinephrine—with the histopathological evaluation and computational prediction of the ablation lesion, we now have the template for a more rational and comprehensive preclinical evaluation and optimization of renal denervation devices. Given that 20% of patients are non-responders to renal denervation devices, we believe that this patient population will ultimately benefit from this next level of understanding of a complex process that has been demystified by our scientists.”
“The CBSET data provide a unique perspective on the determinants of the efficacy of renal denervation devices,” added Elazer Edelman, M.D., Ph.D., chairman and co-founder of CBSET. “The computational models developed by Dr. Rami Tzafriri, principal scientist at CBSET, help explain how to understand the impact of renal denervation and how to optimize this emerging technology. These studies in particular shed light on the importance of treatment parameters such as electrode power and duration, while also revealing the dependence of RF (radiofrequency) energy delivery on the structure of perivascular tissues that vary between individuals,” added Dr. Edelman. “CBSET has raised the bar in empowering the medical device industry to understand how best to manage renal denervation to reduce blood pressure in a larger patient population.”
About Renal Denervation and the New CBSET Paradigm for Preclinical Evaluation of RDN Devices
An increase in renal sympathetic nerve activity has been shown to be a significant contributing factor in developing chronic hypertension. Renal “denervation” seeks to interrupt the nerve signals between the kidneys and the brain that control the blood pressure response to certain stimuli. But, how best to “shut down” these nerve fibers located in the renal artery without surgery, and how can we know that the treatment is effective, safe and durable? Reduction of kidney norepinephrine (NEPI) is a critical biomarker for determining the efficacy of renal denervation. But, the analytical hurdles present in quantifying NEPI in the sub-endogenous range are daunting. Physiological levels of NEPI are puny — and NEPI is inherently unstable, subject to rapid metabolic and non-metabolic oxidative degradation. Nevertheless, accurate measurement of a decrease in NEPI after neural ablation is essential to reliably compare novel technologies. Addressing complex analytical issues, CBSET has developed a novel HPLC-MS/MS assay that accurately quantifies NEPI concentrations in porcine kidney tissue. The innovative assay is specific, sensitive, stable, robust, and linear over three orders of magnitude; indeed, it has significantly upgraded assay performance and data reliability in the sub-endogenous range, allowing assessment of efficacy and aiding in the differentiation and selection of the best treatment for renal denervation.
To learn more about the services provided by CBSET, contact Dr. Erica Smith, Director of Business Development at CBSET: +1-781-296-5319, esmith@cbset.com.
About CBSET
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.