Project Description

Clearwayotw

The ClearWay™ OTW liquid drug delivery balloon is a revolutionary micro-porous PTFE balloon catheter intended for the local delivery of various therapeutic and diagnostic agents into the peripheral vasculature. ClearWay’s semi-compliant low pressure balloon design and atraumatic tip support its use in compromised vessels while reducing the potential for additional vessel trauma.

When used properly, ClearWay OTW has the ability to optimize site specific drug delivery. This is accomplished through ClearWay OTW’s unique mechanism of action which occludes flow, contains the thrombus and allows for selective local infusion of drug.  These actions combined allow the drug to be delivered with minimal dilution and help to increase drug residence time while the balloon is inflated.  The ClearWay OTW drug delivery balloon provides up to 500 times1 the drug concentration (compared to IV drug delivery) at the point of delivery without increasing systemic load beyond the initial bolus delivered.  The ClearWay OTW is an over-the-wire .035” guidewire compatible platform, which allows access to several difficult to reach target destinations throughout the body.

ClearWay OTW is offered in two different configurations:

  • 4.0mm – 8.0mm balloon diameters x 10mm length balloons (These devices are FDA cleared for the delivery of diagnostic and therapeutic agents in addition to embolectomy)
  • 5.0mm – 6.0mm diameter x 50mm length balloons (This device is FDA cleared for the delivery of diagnostic and therapeutic agents)

 

Manufactured by Atrium Medical, U.S.A.

 

1. Data on File