Coronary balloons

Sprinter™ Legend™ RX semicompliant balloon dilatation catheter

<p>The Sprinter™ Legend™ RX balloon catheter is indicated for dilatation of the stenotic coronary arteries or bypass grafts for improved myocardial perfusion.</p>

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Indications, Safety, and WarningsIndicationThe Sprinter™ Legend™ RX and OTW 1.25 mm balloon dilatation catheter is indicated as a pre dilatation catheter for enlarging coronary luminal diameters during PCI procedures. The Sprinter™ Legend™ RX 1.5-4.0 mm balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm–4.0 mm) is also indicated for post delivery expansion of balloon expandable stents.Note: Bench testing was conducted with the Sprinter™ Legend™ rapid exchange balloon dilatation catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturer’s stents due to difference in stent design.ContraindicationsThe catheter is contraindicated for use in:

Unprotected left main coronary artery.

Coronary artery spasm in the absence of significant stenosis.

Warnings

For single patient, single procedure use only. Do NOT resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of inappropriate resterilization and cross contamination.

Do not use the catheter if its package has been opened or damaged.

To reduce the potential for vessel damage the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.

PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.

When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum as this can potentially result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent over pressurization.

PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.

Use only the recommended balloon inflation medium. To prevent the possibility of an air embolus, never use air or any gaseous medium to inflate the balloon.

Use the catheter prior to the “Use By” date (expiration date) specified on the package.

Precautions

Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the procedure for which it is to be used.

The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.

Appropriate anticoagulation, antiplatelet and vasodilator therapy should be administered to the patient.

When using two guide wires, care should be taken when introducing, torquing and removing one or both guide wires to avoid entanglement. Itis recommended that one guide wire be completely withdrawn from the patient before removing any additional equipment.

Sprinter™ Legend™ OTW and Sprinter™ Legend™ RX 3.75 mm–4.0 mm balloon models are not suitable for simultaneous use within a 6F (2 mm) guide catheter [minimum ID 1.8 mm (0.070”)]. Refer to section 11 in the IFU. Note: In the case of simultaneous use of two Sprinter™ Legend™ RX (1.25–3.5 mm only) balloon catheters in one guide catheter, care should be taken when introducing, torquing and removing guide wires and balloon catheters to avoid entanglement.

Care should be taken not to position two Sprinter™ Legend™ balloon catheters in one vessel as inflation in this position may damage the device.

Care should be taken not to apply excessive force during preparation or use as this may damage the device.

If the device is kinked it should not be used.

When inflating the balloon catheter, observe the pressure monitoring device and/or flouroscopic image for any loss in pressure. If loss in pressure is observed, cease inflating, apply negative pressure to fully deflate the balloon, remove the balloon catheter, and inspect the system for possible leaks.

Adverse effectsPossible adverse effects include, but are not limited to the following:

Acute myocardial infarction

Arrhythmias, including ventricular fibrillation

Arteriovenous fistula

Coronary artery spasm

Coronary vessel dissection, perforation, rupture or injury

Death

Drug reactions, allergic reaction to contrast medium

Embolism

Hemorrhage or hematoma

Hypotension or hypertension

Infection

Restenosis of the dilated vessel

Total occlusion of the coronary artery or bypass graft

Unstable angina

Caution: Federal law (United States) restricts this device to sale by or on the order of a physician. See package inserts for the full product information.

Ordering information

Balloon diameter (mm)	Balloon length (mm)							Crossing profile OD mm (in)
Balloon diameter (mm)	6	10	12	15	20	25	30	Crossing profile OD mm (in)
1.25	SPL12506X	SPL12510X	SPL12512X	SPL12515X	SPL12520X	—	—	0.5 (0.020)
1.50	SPL15006X	SPL15010X	SPL15012X	SPL15015X	SPL15020X	—	—	0.5 (0.021)
2.00	SPL20006X	SPL20010X	SPL20012X	SPL20015X	SPL20020X	SPL20025X	SPL20030X	0.6 (0.022)
2.25	SPL22506X	SPL22510X	SPL22512X	SPL22515X	SPL22520X	SPL22525X	—	0.6 (0.022)
2.50	SPL25006X	SPL25010X	SPL25012X	SPL25015X	SPL25020X	SPL25025X	SPL25030X	0.6 (0.022)
2.75	SPL27506X	—	SPL27512X	SPL27515X	SPL27520X	SPL27525X	—	0.6 (0.023)
3.00	SPL30006X	SPL30010X	SPL30012X	SPL30015X	SPL30020X	SPL30025X	SPL30030X	0.6 (0.023)
3.25	—	—	SPL32512X	SPL32515X	SPL32520X	—	—	0.6 (0.023)
3.50	SPL35006X	SPL35010X	SPL35012X	SPL35015X	SPL35020X	SPL35025X	SPL35030X	0.6 (0.023)
3.75	—	—	SPL37512X	SPL37515X	SPL37520X	—	—	0.6 (0.023)
4.00	SPL40006X	SPL40010X	SPL40012X	SPL40015X	SPL40020X	SPL40025X	SPL40030X	0.6 (0.024)

Based on Master validation plan, MVP8079, Sprinter™ Legend™ RX. September 2023.

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