Modular PTA Balloon Catheter System

Covellus Hybrid Platform enables dual purpose catheters to be used with .035" guidewires or couple to adapter modules to add features to the distal end to create multi-function devices

The PTA balloons products serve as a gateway for Modular Catheter Systems and more sophisticated applications

2-Wire (Rapid Exchange / Monorail) Modules

.035" Catheter Parent (Balloon)

1st Guidewire

(over-the-wire)

Second Lumen distal to Parent Module

2nd Guidewire

(rapid exchange)

Single Lumen

Proximal Lumen

Dual Lumen

  • Multiple Configurations, length, durometer, lumen positions

  • Adds an extra lumen to enable the use of 2 guidewires, using either rapid exchange or over-the-wire techniques

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data

  • Extra lumen enables new and advanced techniques, e.g.

    • ​Balloon Anchoring and Centering in the vessel

    • RX wire can be released from Adapter tip in-vivo for alternate use 

Reducer Modules

Reduced Profile Tip

Guidewire

.035" Catheter Parent

  • Reduced profile eliminates ledge at the distal tip of a .035” Parent Module with created smaller guidewires

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data or animal study 

Crossing Modules

Coil Reinforcement and/or Lubricious Coating

Guidewire

.035" Catheter Parent

  • Similar to the Reducer Adapter. Reduced profile eliminates ledge at the distal tip of a .035” Parent Module with smaller guidewire, but may also include reinforcement at the tip or lubricious coating to facilitate tracking

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data or animal study  

Scoring Modules

.035" Catheter Parent

Scoring Wires

Adapter Tip

OTW Scoring

RX Scoring

  • Scoring wires extending from the Adapter tip add scoring elements for focused force dilatation.

  • Accessory device designation where 510(k) clearance leverages the Parent Module FDA approval

  • 510(k) requires no clinical data

  • Multiple configurations, including rapid exchange and over-the-wire, or low profile atherotomes  

Drug Delivery Modules

  • Fibers/mesh are trapped between the vascular wall and balloon allowing a drug or therapeutic agent to elute into the vessel... much like a drug coated balloon

  • The fiber profile provides plaque modification and firm contact with vascular tissue... improving elution

  • Only coating the fibers would allow targeted delivery of higher concentrated therapeutics 

Fiber Mesh

Adapter Tip

.035" Balloon

Imaging/Active Modules

IVUS module

Rear Facing Camera and LED module

View Inside Stent

  • Adapters include conductors to electrically connect the adapter to the proximal end of the Parent Module.

  • Applications include imaging sensors, IVUS transducers, electrodes, pressure sensors, etc... 

Re-Entry Modules

  • Add features of a re-entry device to a balloon

Aspiration / Thrombectomy Modules

  • Add an extra lumen to combine an aspiration funnel with balloon angioplasty

GW Capture Modules

  • Funnel module attached to .035" Catheter (e.g. balloon) to faciliate GW capture

Steering Modules

  • Add articulating tip to balloon catheters

© Covellus 2020