Michael Naimark. “Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation.“ Summary: Whether you are a large established pharma/device group, a small biotech company, a startup, or an academic spinoff, getting your medical technology into the clinic will likely require partnering with experienced contract research groups with regulatory experience and the infrastructure to […]
Tag Archives: 2019
St. Jude’s: Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation
Michael Naimark. “Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation.“ Summary: Whether you are a large established pharma/device group, a small biotech company, a startup, or an academic spinoff, getting your medical technology into the clinic will likely require partnering with experienced contract research groups with regulatory experience and the infrastructure to support […]
EuroPCR: Evaluation of splenic artery denervation: rationale, feasibility, and early pre-clinical experience
Rami Tzafriri, PhD. “Evaluation of splenic artery denervation: rationale, feasibility, and early pre-clinical experience.” Summary: The spleen plays an important role in the immune response to inflammatory conditions including cancer, myocardial infarction and atherosclerosis. Device-based neuromodulation of the spleen’s neural pathways is an emerging therapeutic approach to regulating the immune response in various inflammatory diseases. We evaluated […]
EuroPCR: Vessel preparation system for enhanced plaque modification – Results in calcified human cadaver peripheral arteries
Tzafriri AR. “Vessel preparation system for enhanced plaque modification – Results in calcified human cadaver peripheral arteries“ Summary: Dr. Tzafriri discussed CBSET’s human cadaver model assessment of a vessel preparation system and the attributes of this particular technology that suggest it might be conducive to enhancing drug absorption. Presented at EuroPCR, 2019 May 21-24, 2019, […]
ATVB|PVD Scientific Sessions: In vivo Imaging Assessment of Arterial Permeability Using Indocyanine Green: Implications for Optimizing Drug-Coated Balloon Treatment of Atherosclerosis
Mazen Albaghdadi, Zhonglie Piao, Adam Mauskapf, Mohammed Chowdhury, Rami Tzafriri, Elazer Edelman, Guillermo Tearney, Farouc Jaffer. “In vivo Imaging Assessment of Arterial Permeability Using Indocyanine Green: Implications for Optimizing Drug-Coated Balloon Treatment of Atherosclerosis.” Summary: The efficacy of paclitaxel (PTX) drug-coated balloons (DCBs) in reducing restenosis is limited by Inadequate arterial permeability (AP), yet in vivo […]
EuroIntervention: Pulmonary Artery Denervation Using Catheter based Ultrasonic Energy.
Rothman A, Jonas M, Castel D, Tzafriri AR, Traxler H, Shav D, Leon MB, Ben-Yehuda O, Rubin L. “Pulmonary Artery Denervation Using Catheter based Ultrasonic Energy.” Summary: Pulmonary arterial hypertension is a devastating disease characterized by pulmonary vascular remodeling and right heart failure. Radio-frequency pulmonary artery denervation (PDN) improves pulmonary hemodynamics in pre-clinical and early clinical […]
Toxicologic Pathology: Preclinical Evaluation of Mesh Implants: The Pathologist’s Perspective
Keating JH, Melidone R, Garcia-Polite F. “Preclinical Evaluation of Mesh Implants: The Pathologist’s Perspective.” Summary: Surgical and laparoscopic implantation of mesh devices is on the rise for a variety of applications. The complexity and range of evolving mesh designs calls for consistent and detailed pathologic evaluation in determining host responses and assessing overall safety. This review […]
Toxicologic Pathology: An Overview on the Considerations for the Planning of Nonclinical Necropsies for Medical Device Studies
Stanley JRL, Keating JH, San Souci KJ. “An Overview on the Considerations for the Planning of Nonclinical Necropsies for Medical Device Studies” Summary: The terminal collection and histological processing of medical devices is an expensive, labor-, and material-intensive endeavor, which requires adequate experience, innovation, and preparation for success. It is also an exciting endeavor that continually […]
CRT19 Best Innovation Competition: Enhanced Plaque Modification of Cadaveric Human Calcified Peripheral Arteries Treated with a Vessel Preparation System
Watch: Interview of CBSET’s Director of Research and Innovation, Rami Tzafriri, PhD, by Michael Mooney, MD, of Minneapolis Heart Institute, Abbott Northwestern hospital, at CRT19. Dr. Tzafriri discusses CBSET’s human cadaver model assessment of a vessel preparation system and the attributes of this particular technology that suggest it might be conducive to enhancing drug absorption.
Not a Single Drug Is Approved to Treat Hearing Loss, but Now There Is Hope
CBSET / CILcare Partnership Supports “World Hearing Day 2019,” Sponsored by the World Health Organization (WHO) on March 3rd, to Make Hearing a Priority 1. Hearing loss is at epidemic prevalence. According to the National Institutes of Health (NIH), about three out of every 1,000 children in the United States are born with a detectable level […]