FlexCath Cross™ transseptal solution
For transseptal access
The FlexCath Cross™ system is an integrated transseptal solution with a zero exchange workflow and pairs with commercially available sheaths for both mechanical and radiofrequency (RF) crossing.
Overview
The first and only transseptal access system specifically engineered to pair with commercially available sheaths, including the Medtronic FlexCath Contour™ steerable sheath.
The FlexCath Cross™ system enables a zero exchange transseptal workflow, which adds efficiencies and simplifies left atrial access procedures. FlexCath Cross™ is the only transseptal access system on the market cleared for both mechanical and RF crossing.
Product benefits
Zero exchange workflow
The integrated needle/dilator design removes the need for needle, guidewire, transseptal, and therapeutic sheath exchanges. FlexCath Cross™ helps reduce procedural time of transseptal access by up to 49.9% on average in comparison to traditional mechanical solutions.1,2
Zero sheath exchanges
Dilators compatible with leading industry sheaths eliminate the need for separate transseptal and therapeutic sheaths.
Hear from an experienced Electrophysiologist.
49.9%
average reduction in time for transseptal access1,2
Versatility for your procedures
Choose the FlexCath Cross™ model that fits with your existing sheath preferences for transseptal access. The FlexCath Cross™ transseptal solution is compatible with the following industry-leading introducers and with both mechanical and RF crossing.
Medtronic FlexCath Contour™ Steerable Sheath
Abbott Agilis™* NxT
Steerable Introducer
Mini Sheath with FlexCath Cross™ Transseptal Solution
BioSense Webster CARTO VIZIGO®*
Bi-directional Guiding Sheath
Boston Scientific Watchman™* TruSeal™* and FXD™* Access Systems
Merit Medical HeartSpan™*
Sheath Introducer
Abbott Swartz™* Braided Transseptal Guiding Introducer, SL1
Cross with control
The FlexCath Cross™ needle only deploys when activated, designed for ease of control during transseptal puncture.
Product information
Specifications
- Guidewire
- Conforms to any sheath curve
- Integrated needle (advances 4 mm)
- Dilator shaft
- EGM or RF energy connector
- Needle slide button
- Luer fitting guidewire lumen
Ordering information
| FlexCath Cross™ — AG 61 cm |
Agilis NxT — 61 cm |
900300 |
| FlexCath Cross™ — AG 71 cm |
Agilis NxT — 71 cm |
900301 |
| FlexCath Cross™ — SL 63 cm |
Swartz SL1 — 63 cm |
900302 |
| FlexCath Cross™ — SL 81 cm |
Swartz SL1 — 81 cm |
900309 |
| FlexCath Cross™ — VZ 71 cm |
CARTO VIZIGO — 71 cm |
900303 |
| FlexCath Cross™ — FC 65 cm |
FlexCath Advance™ — 65 cm |
900304 |
| FlexCath Cross™ — WT 75 cm |
Watchman TruSeal and FXD Access Systems — 75 cm |
900308 |
| FlexCath Cross™ — FCC 65 cm 10 Fr |
FlexCath Contour™ — 65 cm, 10 Fr |
900310 |
| FlexCath Cross™ — FCC 65 cm 12 Fr |
FlexCath Contour™ — 65 cm, 12 Fr |
900311 |
Competitive comparison
| Integrated guidewire design reduces exchanges |
◾ |
x |
x |
x |
◾ |
| Indicated for use mechanically or with RF |
◾ |
x |
x |
x |
x |
| Reposition without requiring wire/needle exchange |
◾ |
x |
x |
x |
◾ |
| Engineered to pair with leading sheaths |
◾ |
x |
x |
x |
x |
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FlexCath Cross™
DISCLAIMER
The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s). Please note that the intended use of a product may vary depending on geographical approvals.
See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.
For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI. If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.
Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.
Medtronic products placed on European markets bear the CE mark and the UKCA mark (if applicable). For any further information, contact your local Medtronic representative.
*
™Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
References
1
Rizzi S, Pannone L, Monaco C, et al. First experience with a transseptal puncture using a novel transseptal crossing device with integrated dilator and needle. J Interv Card Electrophysiol. December 2022;65(3):731–737.
2
Yong Ji S, et al. Use of the Novel AcQCross Transseptal System Improves Procedural Efficiency Compared to Conventional Transseptal Puncture Technique. Presented at AF Symposium 2022.
3
BRK Transseptal Needles. Abbott. Available at: https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/access-introducers/brk-transseptal-needle.html. Accessed January 29, 2024.
4
SafeSept Transseptal Guidewire. Pressure Products. Available at: https://pressure-products.com/wip/safesept.html. Accessed January 29, 2024.
5
NRG Transseptal Needle. Baylis Medical. Available at: https://www.baylismedical.com/products/nrg-transseptal-platform/nrg-transseptal-needle/. Accessed January 29, 2024.
6
VersaCross RF Transseptal Solution. Baylis Medical. Available at: https://www.baylismedical.com/ca/products/versacross-transseptal-platform/versacross-large-access-solution/. Accessed January 29, 2024.
