The Protective Nature of a Fluoropolymer Stent

Fluoropolymer Safety Resulting from Fluoropassivation

Yet another factor sets XIENCE apart: the XIENCE fluoropolymer coating. Unlike other polymer coatings, the fluoropolymer interacts with proteins in the blood in a way that reduces thrombus formation—a process known as fluoropassivation.

How Fluoropassivation Leads to Thromboresistance

DUE TO THROMBORESISTANCE AND LOW INFLAMMATORY RESPONSES, FLUORINATED SURFACES ENCOURAGE FASTER ENDOTHELIZATION AND HEALING.1,2

 

Fluoropolymer Stent vs Bare Metal Stent and Biodegradable Polymer Stent

Moreover, XIENCE's fluoropolymer has minimal coating defects compared to biodegradable polymer drug-eluting stents (BP-DES).11 

In contrast to the visual above, most stents available today have non-fluorinated surfaces: biodegradable polymer stents, durable polymer stents or bare metal stents (BMS). These surfaces interact with proteins in the following ways:

  • The surfaces attract less albumin and more fibrinogen.3 
  • The fibrinogen, in turn, leads to more platelet adhesion and activation.12,13 
  • The platelets, fibrinogen and red blood cells can aggregate and create a thrombus.14,15 

CVPath Institute conducted a test to show real time platelet-device interaction between different types of stents.

 
XIENCE compared with Synergy
XIENCE compared with other competitors

Test methodology:

  • Human blood was used to collect blood platelets, which were labeled with fluorescent dye to be visualized under confocal microscopy.
  • Devices to be tested were placed in a flow chamber and labeled platelets were circulated at physiological shear rate.
  • Real-time platelet-device interaction was visualized under confocal microscopy and recorded in a time-lapse video. Image processing was done to quantify platelet deposition on devices.

Visual Evidence of Fluoropolymer Safety

In several analyses, XIENCE exhibits the most thromboresistance when compared to several different BP-DES.16,17 And this reduced inflammation can lead to improved healing.  

Least Thrombus Area with XIENCE vs BP-DES16 

 
Expert's Point of View: Reduced Inflammatory Response

In the images “on the right you can see the [pro-thrombotic] platelet adherence. XIENCE [the image at the bottom] has hardly any attachments to it.”

Renu Virmani, MD, referring to the photomicrographs, where green indicates platelet adhesion

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† Bench test data shows that XIENCE Sierra performed better in crossability and was not statistically different in trackability and pushability compared to Resolute Onyx and SYNERGY stents. Bench test results may not necessarily be indicative of clinical performance. Test performed by and data on file at Abbott. Testing performed on XIENCE Sierra Everolimus Eluting Coronary Stent System (3.0 x 18 mm) n=5, SYNERGY Stent System (3.0 x 20 mm) n=5, Resolute Onyx Stent System (3.0 x 18 mm) n=5. Catheter performance crossability test measures average force to cross a challenging lesion model.


‡ Increased maximum expansion compared to other XIENCE Everolimus Eluting Coronary Stent System.

  1. Szott LM, et al. Biointerphases. 2016;11:029806. doi: 10.1116/1.4944586.
  2. Wertz CF, et al. Langmuir. 2001;17:3006-3016. doi: 10.1021/la0017781.
  3. Panchalingam V, et al. ASAIO J. 1993;39:M305-M309.
  4. Paton DM, et al. U.S. Patent 5,356,668.
  5. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439.
  6. Fluorinated surfaces have been used for cardiovascular implants to benefit from thromboresistance and long-term biocompatibility.
  7. Ao PY, et al. Eur J Vasc Endovasc Surg. 2000;20:241-249. doi.org/10.1053/ejvs.2000.1177.
  8. Lilenfeld R, et al. U.S. Patent 4,564,013.
  9. Chinn JA, et al. J Biomed Mater Res. 1998;39:130-140.
  10. Généreux P, et al. Circ Cardiovasc Interv. 2015;8:e001362. doi:10.1161/CIRCINTERVENTIONS.114.001362.
  11. In vivo coating and degradation study. Photos and data on file at Abbott Vascular. Max deployment in in-vitro degradation solution; vacuum dried for minimum of 5 hours.
  12. Wu Y, et al. J Biomed Mater Res. 2005. doi: 10.1002/jbm.a.30381.
  13. Tsai WB, et al. J Biomed Mater Res. 1999:44:130–139.
  14. Ratner BD, et al. Biomaterials Science, An Introduction to Materials in Medicine, 3rd ed. Elsevier Academic Press, San Diego, CA 2013, pp 551-552.
  15. Garfinkle AM, et al. Trans Am Soc Artif Intern Organs. 1984;30:432-439.
  16. Otsuka F, et al. JACC Cardiovasc Interv. 2015;8:1248-1260. doi: 10.1016/j.jcin.2015.03.029.
  17. Data for XIENCE vs Ultimaster on file with Abbott Vascular. 

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