• Clinical results of first time utilization of Sirolimus Eluting Balloon for treatment of vasculogenic ED demonstrated excellent immediate results with 94% of procedural success in dilating critical stenosis of pudendal and dorsalis penis arteries.
• The clinical success was maintained both in short and long-term follow-up with an improvement of IEF-5 score >5 points in 72% of patients at 3 months and 69% at 8 months follow-up.
• Such results needs to be compared in future randomized studies with the ones obtained with paclitaxel eluting balloon utilization.
All MagicTouch balloons utilize proprietary NANOLUTETM coating technology, which ensures:
• Low in-transit drug loss
• Faster uptake of the drug in the tissue
• Increased bio-availability of the drug
NANOLUTE™ combines scaling down the size of the drug and excipient particle to nano-level, which allows easier uptake of the drug to the tissue, with specific phospholipid based carrier, which encapsulates the drug particles fully, in order to increase Sirolimus lipophilicity.
The functionality of NANOLUTE™ has been tested in several pre-clinical trials which proved that Sirolimus stays inside of artery wall, in effective concentration, up to 14 days post inflation. Additionally, Sirolimus presence has been detected in all 3 arterial layers.
In 40% of cases erectile dysfunction has vascular ethology, which makes it the most common cause of ED. In USA 52% of men between 40 – 70 years of age reports some degree of ED. Worldwide more than 300 million men suffers from ED.
Huge population of patients now can be offered a better and more effective solution.
According to prof. Sangiorgi words: PCI with Sirolimus coated balloon offers hope to men with ED.