Renal Care Solutions

PRESERVE ACCESS
IMPROVE OUTCOMES

At Medtronic, we are committed to providing innovative renal care products and integrating services and solutions to address comorbidities, and expanding access to renal care worldwide. Our goal is to be a partner to improve quality of life and care for patients — and address challenges around cost and access — to take renal care Further, Together. 

INNOVATION HIGHLIGHTS

The Chameleon™ PTA balloon catheter could help provide a more efficient dialysis access maintenance procedure with simpler, more intuitive solutions that combine angioplasty and imaging on one device.

PTA AND INJECTION.
COMBINED.

34.2%
Procedural Time Reduction1*

27.7%
Fluoro Time Reduction1*

49.1%
Contrast Volume Reduction1*

 

Chameleon™ PTA Balloon Catheter. PTA and Injection, Combined.

A Unique Injection Modality for Dialysis Access Maintenance

EDUCATIONAL RESOURCE LIBRARY

  • Procedural videos (dialysis access)
  • Coding guides for Medtronic products
  • Continuing education (CE) courses
  • Peer-to-peer and catheter insertion webinars

Scientific Journal Articles

Procedural Comparison of a Standard PTA Balloon for Fistula and Graft Maintenance Procedures with the Novel Chameleon™ PTA Balloon Catheter

Joel Crawford, Antonios Gasparis, Pamela Kim, Manish Jotwani, Satyaki  Banerjee, Nicos Labropoulos. Journal of Vascular Access. December 2020, https://doi.org/10.1177/1129729820979479.

Click to View the Abstract >

Fistuloplasty Using a Radiation-and Time-Saving Sheathless Balloon Catheter

Joel Crawford, Angela Kokkosis, Pamela Kim, Antonios Gasparis, Nicos Labropoulos. Journal of Vascular Access. 2019, vol. 20(3); 276-280.

Click to View the Full Article >

Introducing Chameleon™: The Next Generation of PTA Balloons

Jeffrey G. Hoggard, MD, John A. Kaufman, MD, and John R. Ross, MD. Endovascular Today. 2017, vol. 16(6); 1-4.

Click to View the Full Article >

 

ONE RELIABLE RESOURCE, AN ADVANCING SPECTRUM OF CARE

*

Statistically significant using multiple regression controlled by lesion location and length.

1

Gasparis, A., Banerjee, S. Procedural Comparison of a Standard PTA Balloon for Fistula and Graft Maintenance Procedures with the Novel Chameleon™ PTA Balloon Catheter. Journal of Vascular Access. 2020; https://doi.org/10.1177/1129729820979479. Accessed Dec. 15, 2020.

© 2021 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. MAHURKAR™*, Double-D™*, and the Double-D design are U.S. registered trademarks of Sakharam D. Mahurkar, used under license. Argyle™* is a trademark of Cardinal Healthcare Inc., used under license. All other brands are trademarks of a Medtronic company. 03/2021 – US-RC-2100018

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Chameleon™ PTA Balloon Catheter Indications, Safety & Warnings

Please see Full Prescribing Information here.
 

Indications for Use

The Chameleon™ PTA Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.  The Chameleon™ enables the infusion of diagnostic or therapeutic fluids.  This catheter is not for use in coronary arteries or cerebral vasculature.

Contraindications

DO NOT use the Chameleon™ Device:

  • For coronary arteries nor for the delivery and/or expansion of stents.
  • In patients who cannot tolerate anticoagulation therapy

Warnings

  • Single patient use only. Do not re-use, re-process or re-sterilize. 
  • Use the recommended balloon inflation medium. DO NOT use air or any other gaseous medium (e.g. CO2) to inflate the balloon or for infusion through the catheter.
  • When the catheter is exposed to the vascular system, it should be manipulated only while under high-quality fluoroscopic observation.
  • DO NOT manipulate the catheter unless the balloon is fully deflated. Never advance / withdraw against any resistance. DO NOT use excessive force. If resistance is felt, determine the cause and take any necessary remedial action. Applying excessive force to the catheter may lead to tissue trauma and / or device damage.
  • DO NOT exceed the RBP recommended on the product label. Balloon rupture may occur if the RBP rating is exceeded. To prevent over pressurization, use an inflation device with manometer.

Precautions

  • Only physicians trained in the performance of PTA procedures should use the Chameleon™ device.
  • The minimal acceptable sheath French size is printed on the product label. DO NOT attempt to pass the catheter through a sheath size smaller than that indicated on the product label.
  • The recommended guide wire size is printed on the package label. DO NOT attempt to use the catheter without a guide wire or with a different size other than the one indicated on the label.
  • If resistance is felt during post procedure withdrawal of the catheter, confirm that the balloon is fully deflated and only then remove the balloon catheter, the guide wire and the introducer sheath as a single unit.

Potential Adverse Reactions

Complications from a peripheral balloon dilatation procedure may include:

  • Allergic reaction to drugs or contrast medium.
  • Aneurysm or pseudo-aneurysm.
  • Arrhythmias.
  • Embolization.
  • Hematoma.
  • Hemorrhage, including bleeding at the puncture site.
  • Hypotension/hypertension.
  • Inflammation.
  • Need for additional intervention.
  • Occlusion.
  • Pain or tenderness.
  • Pneumothorax or Hemothorax.
  • Sepsis/infection.
  • Shock.
  • Short term hemodynamic deterioration.
  • Stroke.
  • Thrombosis.
  • Vessel dissection, performation, rupture or spasm.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.