Express® SD Renal Monorail® Premounted Stent System

Prescriptive Information

Intended Use/Indications for Use

The Express SD Renal Monorail Premounted Stent System is indicated for use as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a single de novo or restenotic atherosclerotic lesion (≤15mm in length) of the renal artery, located within 5mm of the opacified aortic lumen and with a reference vessel diameter of 4.0 - 7.0mm to assist in maintenance of vessel patency.

Contraindications

Generally, contraindications for Percutaneous Transluminal Renal Angioplasty (PTRA) are also contraindications for stent placement. Contraindications associated with the use of the Express SD Renal Monorail Premounted Stent System include:

• Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
• Persons with known allergies to stainless steel or its components (for example nickel)
• A lesion that is within or adjacent to the proximal or distal segments of an aneurysm
• Patients with a target lesion with a large amount of adjacent acute or subacute thrombus
• Patients with excessive vessel tortuosity
• Patients with perforated vessels evidenced by extravasation of contrast media
• Patients with a lesion that cannot be crossed with a wire and/or a balloon catheter

Warnings

Do not exceed the maximum rated burst pressure. As with any type of intravascular implant, infection, secondary to contamination of the stent, may lead to thrombosis, pseudoaneurysm or rupture into a neighboring organ or into the retroperitoneum. The stent may cause thrombus or distal emboli to migrate from the site of the implant down the arterial lumen. When stenting the renal arteries, exercise great care to reduce the risk of plaque embolization. Do not exceed the maximum expanded stent diameter. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just distal to the stenosis. Overstretching of the artery may result in rupture and life threatening bleeding. Use only diluted contrast medium for balloon inflation (typically a 50/50 mixture by volume of contrast medium and normal saline). Never use air or any gaseous medium in the balloon. Persons with allergic reactions to stainless steel or its components (for example nickel) may suffer an allergic response. Do not expose the premounted stent system to organic solvents (i.e. alcohol). Patients with lesions in arteries of transplanted or bypassed kidneys are not recommended for stent implantation. This product contains no detectable latex. The long-term outcome (beyond nine months) for this permanent implant is unknown at present. Stent placement should only be performed at hospitals where emergency peripheral artery bypass graft surgery, including renal artery bypass graft surgery, can be readily performed.

Precautions

The device is intended for use by physicians who have been trained in interventional techniques such as percutaneous transluminal angioplasty (PTA) and placement of intravascular stents. The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspect, it should not be used. Caution should be taken with patients with poor renal function who, in the physician’s opinion, may be at risk for a contrast medium reaction. Note: Patients with serum creatinine ≥3.0 mg/dl were excluded from the Renaissance clinical study. Prep premounted stent system per instructions given in Operational Instructions. Significant amounts of air in the balloon may cause difficulty in deploying the stent and deflation of the balloon. Do not attempt to pull a stent where deployment has been initiated back through a sheath or guide catheter, since dislodgment of the stent may result. If a stent that has not been fully deployed needs to be removed, the sheath or guide catheter and the premounted stent system should be removed as a unit. The SDS is not designed for use with power injection systems. Inflation at a high rate can cause damage to the balloon. Use of a pressure monitoring device is recommended to prevent over pressurization. Do not attempt to manually remove or adjust the stent on the SDS balloon. The minimally acceptable sheath and guide catheter French size is printed on the package label. Do not attempt to pass the premounted stent system catheter through a smaller size sheath or guide catheter than indicated on the label.

When a premounted stent system or SDS balloon is in the body, it should be manipulated only under fluoroscopy. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Never advance the premounted stent system without the guidewire extending from the tip. Prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the stent. If the target lesion is not fully covered, use an additional stent as necessary to adequately treat the lesion. It is recommended that when stenting multiple lesions, the distal lesions should be initially stented, followed by stenting of the proximal lesion. Stenting in this order obviates the need to cross the proximal stent when placing the distal stent and reduces the chances for disrupting the proximal stent. Prior to stent expansion, utilize fluoroscopy to verify the stent has not been damaged or dislodged during positioning. Expansion of the stent should not be undertaken if the stent is not appropriately positioned in the vessel. If the position of the stent is not optimal, it should not be expanded. To assure full expansion, inflate the premounted stent system to at least the opening pressure as shown on the labeling and in Table 1. To assure nominal sizing of the stent, inflate the premounted stent system to nominal pressure as shown on the labeling and in Table 1. Stenting across a bifurcation or side branch could compromise future diagnostic or therapeutic procedures, or could result in thrombosis of the side branch. More than one stent per lesion should only be used when clinically indicated for suboptimal results that compromise vessel integrity and threaten vessel closure, such as edge dissection ≥type B (i.e. bailout). The second implanted stent should also be an Express SD Renal Stent, or a stent of similar material composition, for component compatibility. Do not attempt to reposition a partially deployed stent. Attempted repositioning may result in severe vessel damage. Incomplete deployment of the stent (i.e. stent not fully opened) may cause complications resulting in patient injury. Recrossing a previously deployed stent with adjunct devices must be performed with extreme caution to ensure that the stent does not get caught within previously placed stent struts. In the event of thrombosis of the expanded stent, thrombolysis and PTRA should be attempted. In the event of complications such as infections, pseudoaneurysm, or fistulization, surgical removal of the stent may be required. Use prior to the “Use By” date. The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. The Express SD Renal Stent should not migrate in this MR environment. MR imaging at 3 T or less may be performed immediately following the implantation of the Express SD Renal Stent. In this testing, the stent experienced a maximum temperature rise of 0.96 degrees C at a maximum whole body averaged SAR of 2 W/kg for 15 minutes of MR imaging. The temperature rise was observed to be similar for a stent with a fractured strut. The maximum temperature rise observed for two overlapping Express SD stents was 1.15 degrees C (5 mm overlap at the ends). MR imaging quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent. This stent has not been evaluated to determine if it is safe in MRI systems with field strengths greater than 3T.