A New Category Stent With Novel Polyphosphazene Surface Modification

Abstract

The COBRA-PzF™ (CeloNova BioSciences, Inc., TX, USA) is a new type of coronary stent composed of a cobalt chromium metallic backbone surrounded by a nanothin layer of Polyzene-F (PzF) without any added drug. Evidence from basic studies supports antithrombotic and anti-inflammatory properties for the PzF surface coating. Preclinical studies support the thromboresistance of PzF-coated surfaces and clinical studies have shown good outcomes for patients receiving this device with very low rates of stent thrombosis. COBRA-PzF may be especially useful in patients at high risk for bleeding. Ongoing clinical trials will determine whether shortening the duration of dual antiplatelet therapy to less than 1 month is feasible and these data may represent a new paradigm with regards to patients at high risk for bleeding.

Biomedical applications of polyphosphazenes

“…Xu et al, 2018; L. C. Xu et al, 2020). Polyphosphazenes have been coated on medical devices such as bone implants, heart pumps, stent and other vascular prostheses, to improve the biologic interface between implants and native tissues (Figure 2d, e; Koppara et al, 2016; Mori et al, 2018; L.‐C. Xu et al, 2018; L. C. Xu et al, 2020).…”

“…Polyphosphazene coatings have excellent resistance to thrombosis and decreased platelet adhesion. Thus, biomaterials coated with polyphosphazene have enhanced biocompatibility and suitability for the applications of blood‐contacting medical devices (Koppara et al, 2016; Mori et al, 2018; L.‐C. Xu et al, 2018).…”

Crosslinkable fluorophenoxy‐substituted poly[bis(octafluoropentoxy) phosphazene] biomaterials with improved antimicrobial effect and hemocompatibility

“…A nanocoating developed from TFE, defined commercially as PzF, was applied to a coronary stent and the preclinical testing including in vivo studies in different animal models showed that PzF‐coated stents reduced platelet adhesion, decreased clotting, reduced inflammation and accelerated healing compared with different surfaces and uncoated controls 28–32 . The clinical studies also showed good outcomes for patients receiving the device with very low rates of stent thrombosis, indicating that the PzF‐coated devices may be especially useful in patients at high risk for bleeding 33 . However, the development and applications of TFE in recent decades were primarily focused on reducing thrombogenicity and improving the biocompatibility, while studies for the purpose of antibacterial coatings are limited.…”

“…[28][29][30][31][32] The clinical studies also showed good outcomes for patients receiving the device with very low rates of stent thrombosis, indicating that the PzF-coated devices may be especially useful in patients at high risk for bleeding. 33 However, the development and applications of TFE in recent decades were primarily focused on reducing thrombogenicity and improving the biocompatibility, while studies for the purpose of antibacterial coatings are limited. In our studies, we found that the limited mechanical properties of TFE make its applications in flexible medical devices challenging.…”

Slippery liquid infused fluoropolymer coating for central lines to reduce catheter associated clotting and infections

“…Fluoro-passivation of medical implants is a bio-passive surface modification approach where the medical device surface is coated with fluoropolymer or modified with fluorinated additives to increase their biocompatibility and thereby reduce inflammatory response and thrombogenicity. Several notable commercialized examples in this category are poly(bis(trifluoroethoxy) phosphazene) coated COBRA PzF 18 and poly(vinylidene fluoride-co-hexafluoropropylene) coated XIENCE Sierra coronary stents 19 ; AngioDynamics BioFlo (endexo) PICC catheter and CerebroFlo (endexo) extraventricular drain catheter incorporate A-B-A block copolymer in TPU 20 or silicone rubber as additive. More recently, liquid perfluorocarbon (LP) coatings have emerged as a novel class of slippery omniphobic coatings which was originally produced by infusing liquid perfluorocarbon e.g.…”