Intrepide


Trapidil Eluting Coronary DES

DELIVERY, EFFICACY, SAFETY, STABILITY

Intrepide is a coronary DES, which elutes the drug Trapidil. The system is mounted on the Nimbus Pico rapid exchange catheter platform.

Trapidil has been shown in a number of clinical studies to demonstrate four primary modes of action when given orally:

Anti-proliferative
Vasodilator
Anti-thrombotic
Anti-inflammatory

Trapidil was initially developed in 1971. The drug was initially designed as a vasodilator. However, over the past few decades, studies have found Trapidil to be a potent inhibitor of platelet aggregation and activation, vascular smooth muscle cell proliferation, and monocyte/macrophage migration and activation, thereby making it a potentially potent anti-restenotic agent.


PRODUCT FEATURES

Delivery - The Intrepide is mounted on our Nimbus Pico catheter, which allows for better access to the most complex lesions. The overall profile is the lowest of any DES currently on the market today.

Efficacy - Intrepide has four modes of action which are, anti-inflammatory, anti-thrombotic, anti-proliferative and acts as a vasodilator. These combined make Intrepide one of the most interesting DES developments since their first clinical introduction.

Safety - Results from the DESTINY I trial demonstrate that Product related MACE at 30 days is 0%, Target lesion revascularisation is 5.2% at 180 days and there was no Subacute Thrombosis at 180 days, making Intrepide one of the safest stents on the market

Stability - The Intrepide is a highly temperature stable drug, meaning that it can be used in any ambient atmosphere likely to be encountered in all climates.


CLINCAL EVALUATION DATA
The case for the investigation of the use of Trapidil in a Drug Eluting Stent includes the following points set out below:

MAPK Inhibitor - including PDGF, FGF inhibitor - which also inhibits SMC proliferation in vitro and intimal proliferation in vivo.
Additional anti-platelet and vasodilatory effects
Anti-inflammatory effects
Negligible toxicity
Effective incorporation into a drug /polymer coating on a stent for sustained release and effect at the site

Results from the Destiny trial are summarised below:
Device success in 98%
Procedural success in 100%
No MACE at 30 days
No Sub acute Thrombosis at 180 days
No MI at 180 days
In-stent late loss of 0.72(0.49) is less than in historical bare metal stents (p<0.01), meeting the primary objective
Target lesion revascularization in 6.2% at 180 days

This first in man study has demonstrated excellent safety and clinical outcomes following use of the ICON Trapidil Drug Eluting Coronary Stent

Conclusion: Icon Destiny DES significantly reduces late loss compared to historical BMS controls. It also demonstrates excellent deliverability of the stent. Despite relatively high late lumen loss (LLL), the TLR rate was quite acceptable. There was no MACE at 30 days and no sub acute or late stent thrombosis at 180 days confirming the safety of the stent.