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NRG™ RF Transseptal Kit

A convenient kit for left-heart access using radiofrequency (RF) needle-based workflows, the NRG RF Transseptal Kit includes: NRG Transseptal Needle, TorFlex™ Transseptal Guiding Sheath, and optional ProTrack™ Pigtail Wire.

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Take control of your crossing™

RF needle, sheath, and pigtail guidewire designed to work flawlessly together 

NRG RF Transseptal Kit with NRG Transseptal Needle, TorFlex Transseptal Guiding Sheath, and optional ProTrack Pigtail Wire.

How it works

Animation showing the NRG RF Transseptal Kit in motion


Why choose the NRG RF Transseptal Kit

NRG Transseptal Needle with arrows to pulmonary veins, left atrial appendage, and mitral valve.

Optimize transseptal puncture location to save time and deliver therapy on target1,2

1. Target

NRG Transseptal Needle rounded tip with a circle around it.

Position needle with ease

Atraumatic NRG Transseptal Needle allows you to fine tune your position on the septum

Radiopaque marker of NRG Transseptal Needle during fluoroscopy.

Visualize the needle tip

Radiopaque NRG Transseptal Needle tip allows visualization during your procedure

TorFlex Transseptal Guiding Sheath showing braid composite design.

Controlled torque

Control torque transmission with the TorFlex Transseptal Guiding Sheaths’ special braid design

2. Cross

NRG Transseptal Needle with proven RF puncture technology crossing through thin interatrial septum.

Precise RF puncture

Cross normal, aneurysmal, and fibrotic septa with a short, focused RF pulse from the NRG Transseptal Needle3,4

TorFlex Transseptal Guiding Sheath with arrow pointing to sleek dilator-to-sheath profile.

Smooth transition

Facilitate smooth septum crossing with the TorFlex Transseptal Guiding Sheaths’ smooth dilator-sheath profile

TorFlex Transseptal Guiding Sheath radiopaque band to visualize distal sheath location.]

Visualize sheath tip

Visualize tip location with the TorFlex Transseptal Guiding Sheaths’ radiopaque band

3. Access

Pigtail wire with instantly anchored access into the left atrium.

Instantly anchor

Introduce devices into the left atrium (LA) more quickly.5 Simply deploy the pigtail wire for instantly anchored access into the LA

Varying sheath sizes, illustrating ProTrack's support of multiple sizes.

Exchange sheaths

Facilitate large sheath exchange with the ProTrack Pigtail Wire’s stiff, stainless-steel body

ProTrack Pigtail Wire cushioned against the left atrial wall.

Flexible cushion

Cushion gently against the left atrial wall with the ProTrack Pigtail Wire’s flexible, atraumatic tip


What’s included

The NRG RF Transseptal Kit includes: 

  • NRG Transseptal Needle
  • TorFlex Transseptal Guiding Sheath
  • Optional: ProTrack Pigtail Wire

Required product

RFP-100A RF Puncture Generator.

Designed for controlled tissue puncture using radiofrequency energy

Publication summaries

July 2020, Sanchez et al., published in Journal of Cardiovascular Electrophysiology

This analysis compared the cost-effectiveness of a mechanical needle to an RF device during pulmonary vein isolation (PVI) procedures in three clinical scenarios.


April 2020, Salam et al., published in Journal of Innovations in Cardiac Rhythm Management

This large series of 382 consecutive cases demonstrated the safety and effectiveness of fluoroless transseptal puncture (TSP) and radiofrequency (RF) ablation using 3D electroanatomic mapping (EAM).


April 2018, Tokuda et al., published in Heart and Vessels

This retrospective, propensity score-matched analysis of 232 patients who underwent a catheter ablation procedure for atrial fibrillation compared transseptal punctures performed with a RF transseptal needle to those with a mechanical transseptal needle. 


March 2017, Razminia et al., published in Pacing and Clinical Electrophysiology

This five-year retrospective analysis examined 500 consecutive patients who underwent fluoroless cardiac catheter ablation from December 2010 to March 2016. 


September 2013, Hsu et al., published in Journal of the American Heart Association

Randomized, prospective, and controlled trial. The study included 72 patients randomized to either the NRG Transseptal Needle or a conventional transseptal needle on a 1:1 basis. 


March 2013, Winkle et al., published in Journal of Interventional Cardiac Electrophysiology

This study evaluated the cost-per-procedure used to perform an atrial fibrillation ablation.


September 2011, Winkle et al., published in Heart Rhythm

This large case series compared the safety and efficacy of TSP using the purpose-built RF NRG Transseptal Needle to a sharp mechanical needle for atrial septal puncture. 

NRG Transseptal Needle

 

FeatureSpecifications
Needle curveC0, C1
Needle length71 cm
Proximal gauge18 ga
Distal gauge21 ga

TorFlex Transseptal Guiding Sheath

 

FeatureSpecifications
Sheath curve45°, 55°
French size compatibility8.5F (2.84 mm)
Sheath usable length63 cm
Dilator usable length67 cm

Optional ProTrack Pigtail Wire

 

FeatureSpecifications
Wire diameter0.025”
Overall length175 cm, 230 cm

Ordering information

Products compatible for use with the RFP-100A RF Puncture Generator*

Needle curveSheath curve Pigtail wire lengthProduct code
Curve C045° 230 cmNTK-710-8545
 175 cmNTK-710-8545S
 No pigtail wireNTK-710-8545N
55° 230 cm NTK-710-8555
 175 cm NTK-710-8555S
Curve C145° 230 cmNTK-711-8545
 175 cmNTK-711-8545S
 No pigtail wireNTK-711-8545N
55° 230 cmNTK-711-8555

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* Baylis Medical Company Radiofrequency Puncture Generator RFP-100A

References

  1. Rich, M. E., et al. (2015). Reduction of iatrogenic atrial septal defects with an anterior and inferior transseptal puncture site when operating the cryoballoon ablation catheter. J Vis Exp, (100), e52811. doi: 10.3791/52811
  2. Rinaldi, M. J., et al. (2014). Site-specific transseptal puncture for emerging structural heart interventions. Cardiac Interventions Today, 8(2), 25-9.
  3. Sharma, G., et al. (2016). Accuracy and procedural characteristics of standard needle compared with radiofrequency needle transseptal puncture for structural heart interventions. Catheter Cardiovasc Interv. Epub doi: 10.1002/ccd.26608
  4. Smelley, M. P., et al. (2010). Initial experience using a radiofrequency powered transseptal needle. J Cardiovasc Electrophysiol. doi: 10.1111/j.1540-8167.2009.01656.x
  5. Buchner, S., et al. (2015). Simplified method for insertion of steerable guide into the left atrium using a pigtail guide wire during the MitraClip™ procedure: A technical tip. J Interv Cardiol. doi: 10.1111/joic.12224