NRG™ RF Transseptal Kit

Name: NRG™ RF Transseptal Kit - Boston Scientific
Brand: Boston Scientific

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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Instructions for use are found inside the product packaging and on our product literature website.

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NRG™ Transseptal Needle indications, safety, and warnings

TorFlex™ Transseptal Guiding Sheath indications, safety, and warnings

ProTrack™ Pigtail Wire indications, safety, and warnings

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 target^1,2

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 Needle^3,4

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

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

A cost-effectiveness analysis comparing a conventional mechanical needle to a radiofrequency device for transseptal punctures

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

Safety and effectiveness of a novel fluoroless transseptal puncture technique for lead-free catheter ablation: A case series

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

Radiofrequency needle for transseptal puncture is associated with lower incidence of thromboembolism during catheter ablation of atrial fibrillation: propensity score‐matched analysis

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

Fluoroless catheter ablation of cardiac arrhythmias: A 5-year experience

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 trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study)

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

Physician-controlled costs: The choice of equipment used for atrial fibrillation ablation

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

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

The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation

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

Feature	Specifications
Needle curve	C0, C1
Needle length	71 cm
Proximal gauge	18 ga
Distal gauge	21 ga

Review more NRG Transseptal Needle options

TorFlex Transseptal Guiding Sheath

Feature	Specifications
Sheath curve	45°, 55°
French size compatibility	8.5F (2.84 mm)
Sheath usable length	63 cm
Dilator usable length	67 cm

Review more TorFlex Transseptal Guiding Sheath options

Optional ProTrack Pigtail Wire

Feature	Specifications
Wire diameter	0.025”
Overall length	175 cm, 230 cm

Review more ProTrack Pigtail Wire options

Ordering information

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

Needle curve	Sheath curve	Pigtail wire length	Product code
Curve C0	45°	230 cm	NTK-710-8545
		175 cm	NTK-710-8545S
		No pigtail wire	NTK-710-8545N
	55°	230 cm	NTK-710-8555
	55°	175 cm	NTK-710-8555S
Curve C1	45°	230 cm	NTK-711-8545
		175 cm	NTK-711-8545S
		No pigtail wire	NTK-711-8545N
	55°	230 cm	NTK-711-8555

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Brochures

NRG RF Transseptal Kit brochure

NRG RF Transseptal Kit brochure (without pigtail wire)

NRG Transseptal Needle brochure

TorFlex Transseptal Sheath brochure

ProTrack Pigtail Wire brochure

Analyses

Clinical analysis of RF transseptal puncture - NRG Transseptal Needle

Achieve left heart access with globally trusted RF transseptal technologies

Video

NRG Transseptal Needle animation

* Baylis Medical Company Radiofrequency Puncture Generator RFP-100A. Baylis Medical Company is a wholly owned subsidiary of Boston Scientific Corporation.

References

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
Rinaldi, M. J., et al. (2014). Site-specific transseptal puncture for emerging structural heart interventions. Cardiac Interventions Today, 8(2), 25-9.
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
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
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

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