A Paradigm for Safety Assessment of Energy-Based Devices: CBSET Presents In Vivo Data at “SOT 2016”

Scientists at CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, will present a preclinical paradigm for safety assessment of energy-based devices at the upcoming Society of Toxicology (SOT) annual meeting in New Orleans, March 13-17. These data amplify CBSET’s understanding of the relationship between delivery of thermal energy and potential safety liabilities to surrounding tissues.

The CBSET study data will be presented by CBSET Principal Scientist Dr. Rami Tzafriri in a poster session at SOT (“Safety Assessment of Radiofrequency Renal Denervation in Swine” #P507) on Tuesday, March 15, from 1:15 p.m. to 4:30 p.m. CBSET is also exhibiting at SOT: Booth #1520.

“CBSET continues to expand its understanding of the mechanisms that facilitate safer and more efficacious ablation therapies using in vivo models. Our data provide a ‘must-have’ roadmap for innovators to fully comprehend the distribution of energy in the target anatomy. These data help advance treatment strategies based on a variety of energy-based devices including RF, microwave, and ultrasound, into new and expanded therapeutic areas,” said Peter Markham, President, CEO and co-founder of CBSET.

“Catheter-based renal denervation therapies deliver RF energy from within the renal artery with the aim of denervating the surrounding nerves to modulate the sympathetic nervous system as a therapy for drug-resistant hypertension. The question then is how to balance the local benefits of denervation with potential adverse effects to the artery wall and surrounding organs? Our studies focused both on defining the microanatomy of the renal artery and on quantifying the impact of intravascular delivery of RF energy on the local anatomy — both in terms of inducing efficacy by denervation of the local nerves, and demonstrating safety to the artery wall and surrounding tissues,” explained John Keating, DVM, DACVP, Director of Pathology for CBSET.

“We used histopathology, immunohistochemistry, and morphometry to spatially map the presence of RF-induced changes in arterial and periarterial tissues after multielectrode RF catheter treatment,” said Dr. Keating. “Nerve effects correlated with efficacy biomarkers (e.g., reduction in renal norepinephrine) and revealed a threshold dependence that could be predictably modulated by altering the number of RF treatments. Computational modeling of energy and heat transport also correlated with histopathologic observations in the swine model. We determined that variability in response to treatment resulted from differences in nerve distribution patterns and the presence of structures such as lymph nodes and blood vessels that can draw RF power and dissipate heat, and thus impact both safety and efficacy.”

“This study underscores CBSET’s commitment to evolve techniques and tools to further the field’s understanding of the relationship between safety and efficacy for non-standard therapeutic approaches,” said Dr. Erica Smith, Director of Business Development at CBSET. “The data to be presented at SOT bolsters our understanding of the distribution of RF energy when applied intravascularly in the renal artery as a treatment of drug-resistant hypertension, but also presents a paradigm for understanding the safety and efficacy of all energy-based ablation therapies.” For a copy of the SOT abstract or more information about CBSET, contact Dr. Smith: +1-781-296-5319, esmith@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.

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