As an easy adoption pathway, Covellus has develop a Hybrid Modular System platform where the Parent Module can be existing .035" GW catheters
This strategy has many advantages...
Thousands of potential "Parent Modules" already exist
Existing .035" GW catheters have known safety profiles and are well known to physicians
Development focus can be on the design of the universal interface and initial Adapter Modules
.035" GW catheters come in a variety of performance features, therapeutic modes and elements
The regulatory designation of Adapter Modules is that of an Accessory Device, such that the Regulatory approval of the existing "Parent Module" can be leveraged... streamlining that process
Existing .035" Catheter (Parent Module)
While the Hybrid Platform is an efficient means to introduce Modular Catheter Systems to the market, the benefits of modular systems can be fully realized when both the Adapter and Parent Modules are design to work together.
Control and design of both Modules presents the opportunity for a dedicated lower profile and overall smaller .014" GW compatible system. A dedicated .014" GW modular catheter platform will enable the utility and benefit of modularity in small vessel applications, e.g. infrapopliteal and coronary.
Similar to the .014 Platform, control and design of both Modules presents the opportunity for a dedicated .035" GW compatible system. A robust .035" modular catheter system can move the technology into new and emerging procedural areas where the extra support of .035" guidewires is required, e.g. structural heart and EVAR.
It also provides the opportunity for a three module system.