Go with the flow
Ringer™
Perfusion Balloon Catheter
Introducing the Ringer™ Perfusion Balloon Catheter
The Ringer™ Perfusion Balloon Catheter is a rapid exchange catheter with a helical shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014” guidewire.
The semi-compliant balloon, when inflated, approximates a hollow cylinder. Radiopaque markers at the proximal and distal balloon margins allow visualization and accurate positioning of the balloon catheter in the target segment. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip.
*INDICATIONS FOR USE: The Ringer perfusion balloon catheter is intended for interim management of hemorrhage due to coronary vessel perforations (Types I-III) while facilitating distal perfusion and interventional device delivery until a definitive treatment is determined.
CONTRAINDICATIONS: None.
WARNINGS: 1) To reduce the potential for vessel injury, the Balloon Compliance Chart should be used to select the appropriate size Ringer perfusion balloon catheter based on the corresponding vessel diameter. 2) Use the balloon catheter prior to the ‘Use By’ date specified on the package. 3) The Ringer perfusion balloon catheter is provided sterile for single use only. Reuse of a single-use device creates a potential risk of patient or user infections and may compromise device functionality, which may lead to illness or serious patient injury. 4) To reduce the potential for air embolus into the vessel, use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. 5) 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. Never manipulate the catheter against resistance until the cause of the resistance is determined by fluoroscopy, as this may result in device damage or vessel injury. 6) To reduce the potential for vessel injury, balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on results of in vitro testing. At least 99.9 percent of the balloons (with 95 percent confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization. 7) The crossing profile of the Ringer balloon catheter may result in interactions with previously deployed stents resulting in stent deformation or balloon entrapment. 8) When selecting and positioning Ringer, consider potential for ischemia arising from side branch coverage by the inflated Ringer balloon. 9) Once withdrawn into the guide catheter, the Ringer perfusion balloon catheter should be removed and discarded. The Ringer perfusion balloon catheter should not be re-advanced into the vasculature after being withdrawn into the guide catheter.
PRECAUTIONS: 1) The Ringer perfusion balloon catheter is not intended for treatment of in-stent restenosis or expansion or delivery of a stent. 2) The Ringer perfusion balloon catheter has not been evaluated for the treatment of unprotected left main coronary artery. 3) The Ringer perfusion balloon catheter has a rated burst pressure of 8ATM/800 kPa. Limited data exists in untreated target stenosis with severe calcification. 4) Do not use the Ringer perfusion balloon catheter if the packaging is damaged. A damaged package could indicate a breach of sterility or device damage. 5) Inspect the Ringer perfusion balloon catheter prior to use for damage. Do not use a damaged catheter, as vessel damage and/or inability to advance or withdraw the catheter may occur. 6) Exercise care in handling the catheter during a procedure to reduce the possibility of accidental kinking, bending, or breakage. 7) Do not rotate the catheter more than two (2) consecutive 360° rotations as this may result in the guidewire wrapping around the proximal shaft of the catheter or damage to the catheter. 8) Do not pre-inflate prior to use. Prepare as directed in the preparation for Use section. 9) Care should be exercised when advancing interventional devices through the lumen of the Ringer balloon. Be aware of the potential for adverse Ringer/device interactions. 10) The Ringer perfusion balloon catheter delivery may be difficult or unreliable through heavily calcified or distal vessels.
ADVERSE EFFECTS: The following potential adverse events related to use of the Ringer perfusion balloon catheter have been identified: 1) Arrhythmias. 2) Emergency surgical procedure. 3) Death. 4) Drug reactions, allergic reaction to contrast medium. 5) Heart Failure. 6) Hypotension. 7) Ischemia. 8) Myocardial infarction. 9) Respiratory insufficiency. 10) Side branch occlusion. 11) Stent dislodgement. 12) Stroke, air embolism and embolization or fragmentation of thrombotic or athlerosclerotic material. 13) Tamponade. 14) Thrombosis. 15) Vessel dissection. 16) Vessel perforation. 17) Vessel spasm.
Please see the Instructions for Use for complete product information.
CAUTION: Federal (USA) law restricts this device to sale or use by or on the order of a physician.
Teleflex, the Teleflex logo, and Ringer are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative.
© 2025 Teleflex Incorporated. All rights reserved. MC-009945 Rev 0.2. Revised 11/2025.