Shipments of this product are temporarily suspended in line with ClearStream notice FSN003/13 August 2010, issued in accordance with MEDDEV 2.12-1 rev 6
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.
Product Specification
Catheter specifications
Nominal pressure
2.5 - 4.0mm = 6Atm
Rated burst pressure
2.5 - 4.0mm = 16Atm (4.0 x >30mm balloon = 14Atm)
Average burst pressure
22Atm (4.0 x >30mm balloon = 20Atm)
Average compliance
10%
Average deflation time
<7sec. for 3.0mm x 20mm catheter
Fold
Trifold with memory
Tip Lead in Profile
0.018' (0.457mm)
Shaft
Overall catheter length
142cm (Usable catheter length 135cm)
Distal shaft material
Pebax / Nylon
Distal shaft diameter
2.5 - 3.0mm balloon
2.7F
3.5 - 4.0mm balloon
2.8F
Rapid Exchange transition
XXtraFlex™ Technology
Proximal shaft material
Stainless steel hypotube with lubricious coating
Proximal shaft diameter
2.0F
Hub
Polycarbonate with standard luer fitting
Guidewire
Max. wire diameter 0.014" (0.355)
Marker Bands
Swaged platinum iridium marker bands of length 1.0mm
