Hybrid Adapter Products

Covellus is developing many Hybrid Adapter products to be used with .035" Catheter, for example Percutaneous Transluminal Angioplasty balloon catheters, stent delivery systems and other interventional devices.

The inital products will serve as a gateway for Modular Catheter Systems and more sophisticated applications

2-Wire Adapters

Second Lumen distal to Parent Module

2nd Guidewire

(rapid exchange)

.035" Catheter Parent

1st Guidewire

(over-the-wire)

  • 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 Adapters

Reduced Profile Tip

Guidewire

.035" Catheter Parent

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

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

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

Crossing Adapters

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 Adapters

.035" Catheter

Parent

Scoring Wires

Adapter Tip

  • 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 

Drug Delivery Adapters

.035" Catheter

Parent

Fiber Mesh

Adapter Tip

  • 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 

Imaging/Active Adapters

Camera and LED module

IVUS module

  • Adapters include conductors and low profile connector to electrically connect the adapter to the proximal end of the Parent Module.

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

© Covellus 2020