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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160310005085/en/

News by QuoteMedia

www.quotemedia.com