Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating

• DOI: 10.1007/s40883-019-00097-3
• Publication Date: 2019-03-15T20:15:08Z
• Authors: Mark C. Bates; Ahmed Yousaf; Lee Sun; Mark Barakat; Alexander Kueller
• Keywords: Surface Modification; Thrombogenicity

This manuscript is a review of the preclinical and early clinical findings related to unique fluorinated polyphosphazene nanolayer device surface modification. Polyzene-F (PzF) novel, high-molecular weight, highly pure that was designed enhance biologic interface between medical human tissue or blood. The polymer also has mechanical properties for first time allow implants be paved with coating nanoscale thickness < 50 nm. inherent thrombus resistant takes on biomimetic soon after implant due favorable protein adhesion. Over last 1.5 decades, PzF undergone extensive testing including benchtop endothelial cell migration platelet adhesion studies followed by increasingly sophisticated evaluation in 16 different animal models. consistently shown reduced adhesion, decreased clotting, inflammation, accelerated healing compared surfaces as well uncoated controls. These have translated into compelling evidence suggest enhanced thrombosis can achieved PzF-coated implant. There are now two nanocoated products approved US Food Drug Association (FDA), embolic spheres, coronary stent. detailed overview history, findings, current results attributed emphasis stent Cobra-PzF. few we seen remarkable advances technology development less invasive surgical alternatives treatment heart vascular disease. One key treating preventing attack, stroke, limb loss been stents. Stents small, metallic, mesh-like devices expanded within blocked vessels via small catheters placed through groin wrist. stents provide structural support while vessel heals. challenges other permanent how our bodies react foreign materials. most feared complications which result abrupt closure treated artery. In case stents, cause attack even sudden death whereas clotting neck arteries (carotids) stroke. Additional normal body defense mechanisms include complicated immune responses trigger inflammation scarring resulting recurrence blockage so-called "restenosis." an effort eliminate restenosis, many coated drugs slow prevent healing. downside this approach need long-term blood-thinning medications like Plavix aspirin. article, history new way potentially make invisible subsequent complications. innovation involves compound called (CeloNova BioSciences, San Antonio, TX) layer extremely thin. so thin it cannot strongest available microscopes falls category material science nanotechnology. Nanotechnology materials measured molecular level rather than traditional measurements used field devices. We describe experiments done alongside hypothesis response expected Polyzene-F. initial types disease patients being studied (Cobra-PzF) those at high risk bleeding since know these tolerant medicine. narrow focus selected based experience from team others suggesting do not always predict humans respond treatments coupled knowledge drug-eluting getting better each day. see signals completed Cobra-PzF trials (restenosis) low, but directly compare alternative type study call "randomized trial." ongoing large randomized trial comparing (Cobra PzF) contemporary bleeding, should complete enrollment 2019. At same time, FDA-approved Polyzene-F-coated microbeads (Embozene, Boston Scientific, Marlborough, MA) tumors cancer. If proven conducted currently devices, then enhancement may broader application variety implants.