Relieva Spin Balloon Dilation System

Question 1

Introduction

Answer 1

•The Relieva Spin Balloon Sinuplasty System provides precise, single-handed control for sinus access, dilation and irrigation allowing durable, tissue sparing results.

Question 2

Demo

Answer 2

•It consists of:
o a soft, atraumatic Relieva Spin Sinus Guide Catheter Tip
o the Relieva Luma Sentry Sinus Illumination System
o a flexible Sinus Balloon Catheter
o and integrated suction.

Question 3

Demo cont

Answer 3

•The Relieva Spin is available in two kit configurations: a Frontal Kit and a Maxillary Kit.
o Three Guide Catheter Tips are also packaged separately.
o The tip angles are 0° with a yellow proximal hub, 70° with a green hub, and 110° with a blue hub.

Question 4

Demo cont

Answer 4

• The Guide Catheter Tip contains a soft, atraumatic blue tip that allows for endoscopic visualization.
• A black orientation marker, located near the proximal hub, directs attachment of the Guide Catheter Tips to the Spin Handle.
• The distal clear Balloon Guard protects the Sinus Balloon Catheter during Guide Catheter Tip exchanges.
• The purple Tip Release Button is used to exchange and re-orient the Guide Catheter Tip.
• The non-compliant 6mm x 16mm Sinus Balloon reaches its stated size at 8 atmospheres. The maximum inflation pressure is 12 atmospheres.

Question 5

Demon cont

Answer 5

• A set of markers have been incorporated into the Sinus Balloon Catheter.
• The yellow-green marker enhances endoscopic visualization of the proximal edge of the balloon.
• Two additional endoscopic markers are plus one and plus two centimeters from the proximal edge of the balloon.
• The grey Wire Slider is used to advance and retract the Relieva Luma Sentry Device.
• The white Wire Spinner rotates the tip of the Luma Sentry Device.
• The purple Balloon Slider enables single handed advancement and retraction of the Sinus Balloon Catheter and is clearly marked with the balloon size.

Question 6

Demo cont

Answer 6

• The flow rate of the integrated suction may be increased by covering the suction port with your thumb.
• The Exchange Lever on the back of the Spin Handle enables exchange of the Sinus Balloon Catheter for the Relieva Vortex 2 Sinus Irrigation Catheter.
• The attached Suction Tubing connects to a standard suction source.
• The Acclarent Inflation Device attaches to the proximal luer connector of the attached Inflation Tubing.

Question 7

Demo cont

Answer 7

•Packaged separately, Relieva Vortex 2 Irrigation Catheter is designed for the challenges associated with sinus irrigation or specimen collection.
o The Vortex 2 shaft incorporates a support tube for improved pushability and control.
o The combination of four jets on the side and end of the distal tip, utilizing a 20-60cc syringe, deliver a complete lavage or specimen collection.
o The yellow marker is 3cm from the distal tip.
o Two additional endoscopic markers on the Catheter Shaft are 4 and 5cm from the distal end of the tip.
o A radiopaque marker allows for fluoroscopic visualization of the distal tip.

Question 8

Demo cont

Answer 8

•The Irrigation Tubing, packaged with Vortex 2, may be attached to the proximal luer connector of an irrigation syringe to extend the working length of the device.