LEXINGTON, Mass.--(BUSINESS WIRE)--CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, announced today that its scientists have published data and analyses (“Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis”) that provide critical insights into the barrier effects of calcified plaque on drug delivery and the treatment success of adjunctive lesion preparation therapy.
“This preclinical demonstration of the hindrance of drug distribution by calcified tissue and improved drug delivery after modification of calcified atherosclerotic plaque could have significant clinical implications,” said Michael R. Jaff*, D.O., President, Newton-Wellesley Hospital, and Professor of Medicine, Harvard Medical School.
These data demonstrate enhanced paclitaxel distribution in calcified human arteries after lesion treatment using the Diamondback 360® orbital atherectomy system in a cadaver model with simulated flow and are published in the online Journal of Controlled Release.
“These data suggest that clinical association of diminished efficacy of anti-restenotic drugs in severely calcified arteries is at least partly due to limitations in drug absorption,” Jaff continued.
“The data are exciting in that they suggest that subtle modification to the plaque surface can have profound effects on drug penetration. Massive debulking may be a relic of the past, and a more muted approach may extend endovascular intervention for PAD treatment into vessels even below the knee,” said Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, and senior author of the paper. “This paradigm shift, which relies on quantitative studies, creates an opportunity for the medical device industry to optimize drug delivery therapies to complex lesions.”
“CBSET is committed to the development of novel experimental and computational models for defining the barrier effects of tissue components on drugs of interest and evaluating novel endovascular therapies,” explained Rami Tzafriri, Ph.D., Director of Research and Innovation at CBSET and first author of the paper. “Quantification of the barrier effects of calcified plaque through computational modeling of arterial drug distribution experiments provides a framework by which to evaluate and optimize a range of emerging drug delivery and lesion preparation therapies for peripheral artery disease.”
To learn more about this study and related services provided by CBSET or set an appointment to meet at “VIVA 2017,” please contact: Rami Tzafriri, Ph.D., Director, Research and Innovation, rtzafriri@cbset.org.
About
Peripheral Artery Disease (PAD)
In Europe and North America, an
estimated 27 million individuals are affected with PAD, which is caused
by the accumulation of plaque in peripheral arteries (commonly the
pelvis or leg) reducing blood flow. Left untreated, PAD can lead to
severe pain, immobility, non-healing wounds and eventually limb
amputation. With risk factors such as diabetes and obesity on the rise,
the prevalence of PAD is growing at double-digit rates. Millions of
patients with PAD may benefit from treatment with orbital atherectomy
utilizing CSI’s Peripheral Orbital Atherectomy Systems, minimally
invasive catheter systems developed and manufactured by CSI. These
systems use a diamond-coated crown, attached to an orbiting shaft, which
targets atherosclerotic plaque while preserving healthy vessel tissue —
a critical factor in preventing reoccurrences. Balloon angioplasty and
stents have significant shortcomings in treating hard, calcified
lesions. Stents are prone to fractures and high recurrence rates, and
treatment of hard, calcified lesions often leads to vessel damage and
suboptimal results.
About CBSET
CBSET — 500 Shire Way,
Lexington, MA 02421 — is a preclinical research leader in endovascular
and 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). Learn more about CBSET’s expert
preclinical research services, or please contact
us.
*Dr. Jaff has no formal financial relationship with CSI or CBSET.