About SELUTION SLR™
MedAlliance is the first and only company able to deliver the antiproliferative drug sirolimus in a drug-eluting balloon (DEB) with a sustained release profile similar to that of a drug-eluting stent (DES).
SELUTION’s technology involves the formation of spherical micro-reservoirs made from biodegradable polymer intermixed with the drug. These micro-reservoirs provide controlled and sustained release of sirolimus. The continuous manufacturing process for micro-reservoir formation provides millions of precisely formed, miniature drug delivery systems, each one the same in size with the same drug elution properties.
The micro-reservoirs bind to the surface of the balloon, using MedAlliance’s proprietary Cell Adherent Technology (CAT™). This mixes the micro-reservoirs with amphiphatic lipids (those that contain both positive and negative ions). The lipids envelop the micro-reservoirs, ensuring that they remain on the balloon during its insertion into the artery and delivery to the lesion. As the balloon is expanded at the lesion site, the amphiphatic lipid carrier is attracted to negatively charged membranes in the endothelial cells, resulting in enhanced adhesion of the micro- reservoir coating.
Proprietary Micro-reservoir Technology
- Micro-reservoirs combining sirolimus & biodegradable polymer
- Sirolimus – a proven safe & effective cytostatic drug
- Offering a wider therapeutic range
Cell Adherent Technology (CAT™)
- Contains and protects micro-reservoirs during insertion and inflation
- Facilitates higher drug transfer efficiency allowing for low drug dose on balloon surface
- Maximises drug bioavailability
Micro-reservoirs: Miniature Drug-Delivery Systems
- Optimal size micro-reservoirs achieve elution kinetics similar to best in class DES
- Controlled and sustained release of sirolimus
- Providing therapeutic effect for over 60 days
Once the micro-reservoirs are deposited in the endothelium of the artery at the lesion site, they begin drug delivery and are able to maintain clinically effective levels of sirolimus in the vessel for over 60 days. SELUTION SLR™ is the only DEB using drug delivery micro-reservoirs, which provide the longest and most effective PK release profile of any DEB on market. During the drug release phase, the micro-reservoirs biodegrade, while continuously releasing their sirolimus payload. After more than 90 days, the micro-reservoirs are fully biodegraded, and the vessel is returned to its natural state with nothing left behind.
Pre-clinical animal data shows that therapeutic levels of sirolimus are achieved in tissue for over 60 days. First in Man clinical trial results in peripheral arteries demonstrated a Late Lumen Loss (LLL) of the target lesion of 0.19mm, as measured by Quantitative Vascular Angiography (QVA) at six months post-index procedure. The rate of Target Lesion Revascularization (TLR) was 2.3% – one of the lowest that has ever been reported in a drug-coated balloon FIM study at six months.