PAD-related news and content
How one medtech startup and its preclinical research partner overcame pandemic-related obstacles to continue its medical device research project. Prior to COVID-19, VentureMed was on a roll. The Minneapolis, MN-based company’s first-generation Flex Vessel Prep System had demonstrated promising clinical performance following FDA clearance and the company was preparing to introduce an improved second-generation device. […]
Trio of studies demonstrate that FLEX Vessel Prep System safely and effectively modifies obstructive plaque to facilitate delivery of definitive therapies MINNEAPOLIS, Jan. 27, 2021 — VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator, announced today that data from three studies evaluating the use of its FLEX Vessel Prep (VP) System were presented during […]
Rami Tzafriri, Jay Budrewicz, Lynn Bailey, Peter Markham, Maxen Albaghdadi, Elazer Edelman. Lesion Modification with a Micro-Incision Vessel Preparation System Enhances Balloon-Based Drug Delivery in Complex Porcine Restenotic Lesions. Live presentation abstract: This study examined if and how a vessel preparation system delivering micro-incisions could enhance in vivo paclitaxel (delivered from a DCB) retention in […]
September 30, 2020—CBSET Inc., a not-for-profit translational research institute, announced the publication of a preclinical study, “Balloon-based drug coating delivery to the artery wall is dictated by coating micro-morphology and angioplasty pressure gradients,” by Abraham R. Tzafriri, PhD, et al, online ahead of print in the Journal of Biomaterials.
COVID-19 has significantly and adversely affected preclinical research and clinical trials across the universe of life science companies as a result of the suspension of elective procedures in the U.S. and globally, as well as the challenges posed by travel bans, the furlough of or requirement that clinical study personnel work remotely, restrictions on access […]
Abraham R.Tzafriri, AnnaMariaSpognardi, LynnBailey, JohnKeating, PeterMarkham, GaryBinyamin, MariaPizarro, EitanKonstantino, Elazer R.Edelman. ‘Six Month Safety Evaluation Of The Chocolate Touch™ Drug-coated Balloon Catheter In The Swine Peripheral Artery Model.’ Presented at: CRT 2020, Feb 22-25; National Harbor, MD. Summary: We evaluated the preclinical safety of a novel paclitaxel-coated balloon catheter (PCB) with a nitinol constraining structure positioned over it, […]
August 28, 2019—CBSET announced that its scientists have published data and analyses that provide critical insights into the interplay between target anatomy and device attributes in determining balloon- and stent-based paclitaxel retention in healthy and diseased arteries. According to CBSET, these findings may transform the understanding of the safety and efficacy of paclitaxel-coated devices used […]
September 11, 2017—CBSET announced that its scientists have published data and analyses regarding the barrier effects of calcified plaque on drug delivery and the treatment success of adjunctive lesion preparation therapy in the treatment of peripheral atherosclerosis. CBSET is a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies. According […]
Rami Tzafriri; Peter Markham; Brett Zani; Steve Alston; Elazer Edelman. ‘Multiple drug coated balloon exposures increase arterial permeability and drug retention.’ Presented at: Innovations in Cardiovascular Interventions (ICI), Dec 4-6, 2016, Tel Aviv, Israel. Summary: It is thought that increased dose or number of drug-coated balloon (DCB) inflations increases drug delivery and tissue retention – this […]
May 20, 2015—CBSET, a preclinical biomedical research institute, announced findings from a cadaver study suggesting that modification of atherosclerotic plaque with the Diamondback 360 orbital atherectomy system (Cardiovascular Systems, Inc. [CSI]) improved drug uptake in calcified peripheral lesions. Gunnar Tepe, MD, from RoMed Hospital in Rosenheim, Germany, stated in CBSET’s announcement, “This preclinical study could have a significant […]