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Pre-Clinical Trials
   
Rabbit model of iliac artery study
Time frame: 2007
Conducted by: Renu Virmani, M.D., U.S. 
Status: Completed

The objective of this study is to compare various formation of drug-eluting stents and bare metal stent implantations in atherosclerotic arteries in rabbits (N = 69). Young adult New Zealand rabbits (3.0 - 4.0kg) underwent catheterization of the iliofemoral vessels using the carotid artery for vascular access. BuMA™ with coating alone, BuMA™ with biodegradable polymer, BuMA™ with biodegradable polymer and sirolimus are compared to Cyper™ and bare cobalt chromium stent. Totally, 66 stents were submitted for light microscopy analysis, 70 were submitted for scanning electron microscopy and immunostained for en face confocal microscopy.

Study outcomes

 

     

 

Conclusion

   First-generation DES (SES and PES) show poor re-endothelialization with poorly formed cell junctions (as demonstrated by SEM and reduced PECAM-1 expression) as well as decreased expression of antithrombotic molecule thrombomodulin, and reduced nitric oxide production, as compared to 2nd-generation DES (ZES and EES).

    eG™ BuMA™is an effective base layer for drug loading & coating mechanical integrity.

   eG™ BuMA™promotes re-endothelialization very effectively alone.

   Re-endothelialization of eG™ SES parallels Cypher® until completion of erodable matrix disappearance, and is superior to Cypher® thereafter, presumably targeting  eG™ BuMA™i.e. complete re-endothelialization.

Swine porcine study
Time frame: 2013
Conducted by: Renu Virmani, M.D., U.S. 
Status: Completed

This analysis compares BuMA™ (N=18) with XIENCE V (N=15) when implanting both stents in swines for 45 days. With OCT analysis, strut coverage, non- overlapping and overlapping between two stents are evaluated. The overlapping take place in left circumflex artery (LCX) and left anterior descending (LAD). Non-overlapping implantation take place in the right coronary artery (RCA). Study endpoints are stent area, lumen area and neointimal thickness at 14 and 45 days. 

Study outomes

 

Conclusion

Both BuMA™ and XIENCE V showed complete endothelialization in 45 days, and also excellent neointimal coverage even in 14 days. Further, all histologic parameters were comparable between BuMA™ and XIENCE V. Finally, OCT analysis has shown accurately measured neointimal thickness with excellent correlation with histology.

This study is expected to be published in the 2nd quarter of 2014.