“The combination of both preclinical experiments and computational models is necessary to understand the basis of clinical efficacy: variation in ablation zone geometry caused by diversity in local tissue anatomy,” said Peter M. Markham, President and CEO, CBSET.
LEXINGTON, Mass., May 4, 2015 — CBSET, 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 (“Arterial microanatomy determines the success of energy-based renal denervation in controlling hypertension”) that provide critical insights into the predictability, variability and treatment success of catheter-based renal denervation (RDN) therapy. These data suggest that new, optimal alternative devices compared to first-generation RDN systems may enhance or assure efficacy and are published in the FOCUS article in the latest issue of Science Translational Medicine, a publication of the American Association for the Advancement of Science (AAAS).
“Though a large body of scientific research has convincingly demonstrated the link between sympathetic activity and hypertension, catheter-based renal denervation has been confounded by unreliable efficacy in some late-stage clinical trials. The published data have demonstrated that anatomical asymmetries along the length and circumference of the renal artery can limit the efficacy of ablation therapies in the treatment of resistant 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.
“Conflicting data from recent clinical trials must not deter the community. Sympathetic denervation and neuromodulation techniques still provide an exciting opportunity for the treatment of diseases with increased sympathetic tone, such as hypertension and of a variety of other cardiovascular diseases. 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 illustrate that electrode irrigation can protect the artery wall during efficacious ablations without diminishing ablation area in the nerve rich peri-arterial compartment,” said computational modeling expert and CBSET Principal Scientist Dr. Rami Tzafriri, lead author of the published study.
“Mechanistic insight bridges the preclinical and clinical experiences and is in the end 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 a copy of the paper, or to learn more about CBSET,, contact: Erica Smith, Ph.D., Director, Business Development: +1-781-296-5319, esmith@cbset.com
About CBSET
CBSET — 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. CBSET occupies a 35,000-square-foot, state-of-the-art facility near Boston that includes a vivarium, catheterization/imaging labs, surgical suites, dedicated labs for SEM, histopathology/pathology, and drug metabolism and pharmacokinetics. CBSET offers the latest equipment for fluoroscopy, echocardiography (TEE/TTE), electrophysiology, IVUS, optical coherence tomography (OCT), endoscopy/laparoscopy, surgical video recording, histology, microradiography, and SEM (Scanning Electron Microscopy).