Cardiology : Percutaneous Coronary Intervention/PCI
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat narrowing (stenosis) of the coronary arteries of the heart found in coronary artery disease. ... Various other procedures can also be performed.
The sirolimus-eluting coronary stent angiolite is made from a cobalt chromium alloy called L605, coated with a mix of sirolimus and last generation of biostable polymers. The stent is pre-mounted on the delivery system that will allow implantation on the coronary lesion to treat thanks to the inflation of a balloon at the distal end of the catheter.
The stent is manufactured from a metal tube that is laser cut and subsequently subjected to various treatments that will give the surface a smooth, glossy finish. The stent design is based on a concatenation of cells in the circumferential direction that are connected to each other axially by means of links to obtain different longitudinal configurations. Moreover, the adjustment of the number of cells in the radial direction allows the stent to be expanded to different diameters. The result is an open cell design.
The stent delivery system is a rapid exchange balloon catheter also called RX, having a single lumen configuration on the proximal part and a coaxial double lumen configuration on the distal part. The catheter has an inflatable segment (balloon) in its distal end. The balloon is designed to achieve different diameters and lengths, engaging the stent in its different configurations and covering the range of lesions to be treated. Before positioning, the balloon is folded and the stent is compressed over it. There are radiopaque markers delimiting the length of the stent and to facilitate observation under fluoroscopy. When the balloon reaches the lesion and is inflated, the stent expands against the artery. Subsequently, the balloon is deflated and removed and the stent remains permanently implanted.
The distal part of the catheter is coated with a durable hydrophilic coating to minimize friction and improve its trackability.
The inflatable segment is coated with a homogeneous mixture of the drug Sirolimus (Rapamycin) and a biostable fluoroacrylate polymer yielding a drug dose of 1.4 µg/mm2.
- Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2 mm to 4.5 mm
- Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2 mm to 4.5 mm.
- iVascular’s proprietary coating technology “TransferWise”. Nanotechnology drop dosage system that yields a multilayer thin coating.
- Improved coating mechanical resistance. Better adhesion to the stent. Homogeneous, durable and flexible formula.
- Triple layer coating (primer + matrix + top) to yield a controlled Sitrolimus eluting profile.
- Fluorinated acrylate polymer with selective cellular activity: Prevents smooth muscle cell deposition while enhancing rendothelization.
- Specific stent design for DES: alternate spiral links and more crowns per turn for a balanced arterial coverage to assure homogeneous drug distribution.
- Outsanding radial force, best in its class.
- Faultless coating after stent expansion
- Ultrathin strut design (75 µm) for clinical safety
- Very low crossing profile and hydrophilic coated shaft for smooth trackability
- Stent material: CoCr L605
- Strut thickness: 75 µm – 85 µm depending on stent diameter. Links 70 µm
- % recoil: < 5%
- % shortening at expansion: < 3%
- Drug: Sirolimus 1.4 µg/mm2
- Polymer: Biostable fluorinated acrylate
- Catheter materials: Nylon / Pebax. No latex components.
- Semi-compliant balloon
- Nominal pressure: 9 – 12 atm
- Rated Burst Pressure (RBP): 16 atm
- Average Burst Pressure (ABP): 22 atm
- 2 Pt/Ir radiopaque markers on the catheter delimiting the stent
- Guiding catheter compatibility: 5F
- Catheter’s working length: 142 cm
- Recommended guidewire: 0.014”
- Entry profile: 0.016”
- Wide size range
The treatment of the heart requires superior medical device safety, followed by clinical efficacy
RESTORE is a major step beyond contemporary first and second generation DEB devices.
• The Restore Paclitaxel releasing coronary balloon dilatation catheter provides a unique ‘SAFEPAX’ balloon surface drug coating quality.
• Restore is a major step beyond contemporary first and second generation DEB coatings, which have to compromise on vulnerable balloon coating mixtures out of a high water-soluble drug excipient matrix with relatively large PTX crystals.
• Only the smallest PTX particle size appears safe enough to bear no risk for any collateral myocardial damage, caused by distal embolization.
• Restore ensures a high patient safety by non-visible 0.1μm smallest PTX particles leapfrogging ahead of 2.0-3.0μm large Paclitaxel crystals on most DEBs.
• The stable, indestructible Restore balloon surface coating features the leading edge drug coating finesse, which does not require the use of an extra DEB protection and insertion tool. The Paclitaxel balloon coating of Restore cannot be wiped or fall off the balloon surface during catheter manipulation.
The Xposition Platform is designed to optimise the treatment of challenging cases by ensuring complete and continuous apposition for improved patient outcome.
Developed for vessels at high risk of malapposition with conventional stents, such as those with a diameter mismatch or diameter that may change over time (thrombus laden or vasoconstricted vessels).