1. Drug Eluting Valvuloplasty Balloon Catheter
DCB - V
Drug Eluting Valvuloplasty Balloon Catheter

2. Rembert Pogge von Strandmann PhD
Royalty income for this project
from Eurocor GmbH Germany

3. *Contributed equally, +Presenting author
Valvuloplasty with a Paclitaxel-Coated Balloon („DCB-V“) Prevents Restenosis in an Experimental Animal Model of Aortic Stenosis
Konstantinos Spargias1*, Mariann Gyöngyösi2*, Dominik Kieselbach3, Rembert Pogge von Strandmann3+ 
1 Department of Transcatheter Heart Valves, Hygeia Hospital, Athens, Greece, 2 Department of Cardiology, Medical University of Vienna, Austria, 5 Eurocor GmbH, Bonn, Germany
*Contributed equally, +Presenting author

4. Background
Restenosis rates after balloon valvuloplasty (BAV) in calcific aortic valve disease (CAVD) is up to 83% after six months, and almost 100% within one year after the procedure.

5. Aim of the Study
Investigation of the potential role of a paclitaxel-eluting valvuloplasty balloon to mitigate the progression of restenosis in an animal model of CAVD.

6. Investigational Device – „DCB-V“
Paclitaxel balloon surface: 3 µg/mm²
Coating is a 1:1 mixture of paclitaxel and shellac
Shellac swells in blood and releases paclitaxel under pressure
The coating is CE marked
Shellac is in accordance with the FDA “Inactive Ingredients Guide“
DCB-V 8 mm in diameter, 20 mm in length

7. Study Flow Chart
A special diet has been used to induce a significant decrease in AVA and to increase the transvalvular pressure gradients
Animals were randomized 1:1 to DCB-V vs. POBA treatment
Follow-up 1 month after procedure

8. Results I

9. Results II
Baseline and post-BAV AS severity, as assessed by several echocardiographic indices, were similar between the groups. However, at one month after BAV the AVA was significantly larger, but the SWL loss and aortic valve resistance were significantly lower, in the paclitaxel-BAV group.
At follow up, indices of left ventricular systolic performance, such as fractional shortening and SWL were improved in the paclitaxel-balloon compared to the plain-balloon group.

10. Results III
At one month after BAV, the reduction in AVA resulted in a significant increase in the mean invasive pressure gradient in the plain-balloon group and a non-significant increase in the paclitaxel-balloon group
This led to a trend for a lower mean gradient at follow up in the DCB-V group

11. Results IV
Histology demonstrated a marked decrease in collagen trichrome staining and cell proliferation in the aortic valve leaflets in the paclitaxel-balloon group compared to the plain-balloon group.

12. Results V
The paclitaxel-treated balloon substantially decreased the calcification response as compared to the uncoated balloon.
This led to a significantly smaller leaflet thickness in the paclitaxel-balloon group compared to the plain-balloon group.
A significant reduction in the mean PCNA stain grade in the paclitaxel-balloon group was observed.

13. First publications
Paclitaxel-eluting balloon in experimental disease K. Spargias et al. J Heart Valve Dis Vol. 23. No. 3 May 2014
Testing Drug Eluting Paclitaxel Balloon Valvuloplasty in an Experimental Model of Aortic Stenosis; Page 41ff in: Molecular Biology of Valvular Heart Disease ISBN ISBN (eBook) DOI / Springer London Heidelberg New York Dordrecht Edited by Nalini M. Rajamannan

14. Patents Valvuloplasty
Europe EP pending
Brazil pending
India n/a pending
Russia GRANTED
USA 8/187, GRANTED

16. Conclusion
Restenosis was less evident in valves dilated with the paclitaxel-eluting balloon.
There were also reductions in ECM synthesis, cell proliferation and calcification in the paclitaxel-balloon treated leaflets
(i) a decreased leaflet thickness
(ii) a larger AVA
(iii) a diminished SWL
(iv) a decreased aortic valve resistance.
Together, these observations suggest that local paclitaxel delivery attenuated the myofibroblast osteogenic differentiation that drives the restenosis process and is typically seen following BAV with a plain balloon.