PROx Gen2
The PROx™ Gen2 range is the latest innovation and evolution of the gold-standard PROx high-performance proximal catheter shaft subassembly.
PROx™ Gen2
The PROx™ Gen2 range is the latest innovation and evolution of the gold-standard PROx high-performance proximal catheter shaft subassembly. PROx Gen2 uses very limited PFAS materials or none, dependent product version, which limits the amounts of harmful substances that are produced and discharged back into the earth. It retains the premium Rx catheter design features of the PROx range, including TE’s unique material - Polevault - and is manufactured in a high-yield, robotic, semi- or fully automated environment.
Future Proofing Your Device Development. Pending regulatory changes in the medical device market seek to better manage, limit or ban select “forever chemicals” in product manufacturing. Device manufacturers are challenged with sourcing sustainable components to stay ahead of ever-changing regulations.
With the PROx Gen2 range, TE is uniquely positioned as a supplier of environmentally-friendly device component parts with the advancement of future-proof, sustainable technologies. With over 25 years of experience in manufacturing hypotubes, TE has transformed the PROx product into the new PROx Gen2 range. This reimagined range introduces a fresh perspective to proximal catheter shafts, and future-proofs medical device development for a dynamic regulatory environment. TE can partner with you to design and develop components that help you stay ahead of these anticipated regulatory changes.
PROX GEN2 PRODUCT PORTFOLIO
The new PROx Gen2 product portfolio comes in three hypotube variations.
PROx Gen2 Coat
PROx Gen2 Coat is an adaptation of TE’s original PROx product. The new “coating” is a low PTFE water-based coating that is REACH and RoHS compliant. The coating is biocompatible and environmentally friendly. The coating is PFOS-free and PFOA-free that doesn’t utilize harsh solvents which means it is NMP-free and Hexavalent Chromium-free.
PROx Gen2 Pad Print
PROx Gen2 Pad Print is an alternative to PROx Gen2 Coat that eliminates any potential regulatory concern that can arise from the coated version. It has the recognizable hub of PROx Gen2 Coat but with pad print marker‘s on TE‘s Polevault material. The wire is welded at the distal end of the hypotube to support the function of the customers end device.
PROx Gen2 Skive
PROx Gen2 Skive is an uncoated hypotube with pad print marker’s on TE’s Polevault hypotube. Instead of a wire at the distal end, this product has a skive. This product is manufactured in Costa Rica to keep costs low.
KEY ATTRIBUTES & SPECIFICATIONS
Key Attributes
Optimum Design
As catheter design matures, there is convergence towards design features that can deliver improved clinical performance to optimized delivery of the balloon and stent:
- Enhanced kink resistance - PoleVault hypotube shafts delivers up to 40% improvement in kink resistance over conventional materials
- Robust flexibility in transition zone - core wire design ensures flexible and smooth transition to distal balloon assembly
- Coating to optimize trackability - low-PTFE coated shafts are an evolution of the existing industry standard for Rx catheters
- Overall design achieves optimal balance of push, kink resistance, trackability and deflation time
Optimum Manufacturing
PROx Gen2 Coat and Pad Print are produced using a semi- or fully automated cellular manufacturing configuration that delivers enhanced product consistency and quality, scale and optimizes cost efficiency.
Optimum Access
Order and delivery of PROx Gen2 is simple and efficient. A standard transaction procedure simplifies the supply chain. PROx Gen2 is a build-to-stock item ensuring reliability of supply to meet individual unit requirements and order patterns.
Optimum R&D
PROx Gen2 product samples for R&D are available on request. This option for low-volume, of-the-shelf inventory helps speed your device design, while reducing NRE.
Specifications
| PROx Gen2 Coat | PROx Gen2 Pad Print | PROx Gen2 Skive | |
|---|---|---|---|
| Description | Premium coated (low PTFE) hypotube | Optimized uncoated hypotube | Optimized uncoated skived hypotube |
| Material | Gold standard Polevault hypotube | Gold standard Polevault hypotube | Gold standard Polevault hypotube |
| Production details | Flexible transition zone with wire weld | Flexible transition zone with wire weld | Skived transition zone—options for 30mm, 50mm, and 150mm |
| Strain relief | Overmolded | Overmolded | Extruded |
| Manufacture site | Galway, Ireland | Galway, Ireland | Heredia, Costa Rica |
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