NRG™ Transseptal Needle

Name: NRG™ Transseptal Needle - Boston Scientific
Brand: Boston Scientific

The NRG Transseptal Needle delivers a short and highly-focused radiofrequency energy pulse, enabling a precise and controlled transseptal puncture.

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

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Be precise. Save time.™

Improve crossing success rates^1-3 and reduce procedure time^3,4 with the radiofrequency (RF) NRG Transseptal Needle

NRG Transseptal Needle, glowing yellow at the tip.

How it works

Clinical footage comparing the NRG Transseptal Needle to a mechanical transseptal needle

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

Why choose the NRG Transseptal Needle

Clinical advantages*

Using RF energy for your transseptal puncture (TSP) saves time,^3,4 reduces the rate of serious complications,^1-6 and increases success rates as compared to mechanical alternatives

Read the clinical analysis (PDF)

NRG Transseptal Needle puncturing through the thin interatrial septum, glowing yellow at the tip.

Cross difficult anatomies¹

Cross aneurysmal septa while reducing excessive tenting,³ and cross fibrotic septa while reducing mechanical force.²

Lower risk of serious complications^1,3-6

Reduce the rate of serious complications attributed to transseptal puncture with the use of a radiofrequency needle.^1,3-6

The rounded tip of the NRG Transseptal Needle with a circle around it.

Cross with precision

Cross the septum at precise locations. Fine-tune your position with the rounded atraumatic tip prior to RF delivery.

Chart illustrating a 32% reduction in procedure time with the use of an RF needle versus a mechanical needle.

Save time

Experience a shorter, more predictable transseptal puncture time.^2-4 Reduce fluoroscopy time for TSP.^3,5

Radiopaque marker of NRG Transseptal Needle during fluoroscopy.

Visualize the RF needle

Locate the RF needle on your mapping system. Visualize the tip’s exact location with a radiopaque marker during fluoroscopy.

Transseptal Needle with skiving and red X, and NRG Transseptal Needle with no skiving, rounded tip, and green checkmark.

Reduce skiving

Reduce skiving risk when advancing through the sheath and dilator with a rounded atraumatic tip.^†5,7

Required product

RFP-100A RF Puncture Generator^‡

Designed for controlled tissue puncture using radiofrequency energy

Clinical highlights

April 2020, study led by Dr. Salam, 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 TSP and RF ablation using 3D electroanatomic mapping (EAM).

Faster fluoroless transseptal time

Double or single TSP was achieved 100% successfully and without fluoroscopy within 28±15 min.

Reduced procedure time

Total procedure time was 135±34 min without significant complications

Read the fluoroless transseptal puncture study summary

Read the complete study on PubMed

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 TSP and RF ablation using 3D 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 curves	C0, C1
Needle lengths	56 cm, 71 cm, 89 cm, 98 cm
Dilator compatibility	0.032"

Compatibility table

Compatible transseptal sheaths	Needle length
6F small anatomy fixed curve - 48 cm	56 cm^§
8F or 8.5F fixed curve - 63 cm	71 cm
8.5F steerable curve - 72 cm	98 cm

Compatible with 0.032” dilator systems

^§ Proximal gauge 19 ga, distal gauge 22 ga

Ordering information

Needle curve	Needle length	Product code
Curve C0	56 cm^§	NRG-E-56-32-C0
	71 cm	NRG-E-HF-71-C0
	89 cm	NRG-E-HF-89-C0
	98 cm	NRG-E-HF-98-C0
Curve C1	71 cm	NRG-E-HF-71-C1
Curve C1	98 cm	NRG-E-HF-98-C1

Compatible with 0.032” dilator systems

^§ Proximal gauge 19 ga, distal gauge 22 ga

Looking for more training? Contact our medical education team

In-person training

Explore in-person training opportunities for electrophysiologists and interventional cardiologists of all experience levels.

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Online education

Utilizing RF for Transseptal Puncture

Bradley Knight, MD, shares an overview and techniques of the NRG Transseptal Needle

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On-site transseptal simulator training

Hands-on training on the use of RF-based transseptal platforms in various clinical scenarios using virtual reality technology, echocardiography simulators, and anatomical models.

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Brochure

VersaCross™ & NRG portfolio overview

NRG Transseptal Needle brochure

NRG RF Transseptal Kit brochure

NRG RF Transseptal Kit brochure (without pigtail wire)

Analysis

Clinical analysis of RF transseptal puncture - NRG Transseptal Needle

Achieve left heart access with globally trusted RF transseptal technologies

Video

NRG Transseptal Needle animation

NRG RF Transseptal Kit animation

* All clinical claims in this section are supported by published literature; some claims are supported by study designs other than randomized controlled trials.

† In vitro study simulating transseptal catheterizations. Any particles generated from advancement of the transseptal needles through the sheath and dilator were collected and analyzed.

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

§ Proximal gauge 19 ga, distal gauge 22 ga

References:

Jauvert, G., et al. (2015). Comparison of a radiofrequency powered flexible needle with a classic rigid brockenbrough needle for transseptal punctures in terms of safety and efficacy. Heart Lung Circ. Doi: 10.1016/j.hlc.2014.07.073
Hsu, J. C., et al. (2013). Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA Study). J Am Heart Assoc. doi: 10.1161/JAHA.113.000428
Fromentin, S., et al. (2011). Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. Doi: 10.1007/s10840-011-9564-2
Winkle, R. A., et al. (2011). The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation. Heart Rhythm. Doi: 10.1016/j.hrthm.2011.04.032
Yoshida, S., et al. (2016). Feasibility and safety of transseptal puncture procedures for radiofrequency catheter ablation in small children weighing below 30 kg: Single-centre experience. Europace. Doi: 10.1093/europace/euv383
Feld, G. K., et al. (2011). Particle formation and risk of embolization during transseptal catheterization: Comparison of standard transseptal needles and a new radiofrequency transseptal needle. J Interv Card Electrophysiol. doi: 10.1007/s10840-010-9531-3
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

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