Radiofrequency NRG® Transseptal Needle

Radiofrequency NRG® Transseptal Needle

The radiofrequency NRG® Transseptal Needle is uniquely designed to assist the physician in gaining access to the left atrium by using RF energy in a controlled manner as opposed to mechanical force. The radiofrequency NRG® needle uses radiofrequency (RF) energy  in a safe and controlled manner. This allows the physician to advance across the septum in a precise manner without using excessive force.

Radiopaque tip
  • Identify the tip in the dilator
  • View tip in the left atrium
Know exactly where the tip is at all times
  • Visualize the needle tip’s position both inside or outside the dilator
  • Confidently guide the needle throughout the transseptal procedure
  • Provide enhanced guidance when training fellows
Cross thin aneurysmal septa
  • Reduce the need for excessive tenting and risk of needle jump1
Cross thickened, fibrotic septa
  • Reduce the force required1
Faster procedure times
  • Reduce procedure1-2 time
  • fluoro-radiation1 times
No skiving
  • Reduce the creation of plastic particles and the risk of embolization3

References 

1 Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. Fromentin et al. — J Interv Card Electrophysiol. DOI 10.1007/s10840-011-9564-2
(Read the Summary - PDF)

2 The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation. Winkle et al.— Heart Rhythm, Vol 8, No 9, September 2011
(Read the Summary - PDF)

3 Particle formation and risk of embolization during transseptal catheterization: comparison of standard transseptal needles and a new radiofrequency transseptal needle. Feld et al. — J Interv Card Electrophysiol. DOI 10.1007/s10840-010-9531-3
(Read the Summary - PDF)

Rx only. Before use, consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use. 

Summary: Physician-controlled costs: the choice of equipment used for atrial fibrillation ablation
Authors: Roger A. Winkle & R. Hardwin Mead & Gregory Engel & Melissa H. Kong & Rob A. Patrawala
PDF, (140.71 KB)
Last updated: 2013-07-26
Site-Specific Transseptal Puncture for Emerging Structural Heart Interventions
Authors: Michael J. Rinaldi, MD, FACC, FSCAI; Markus Scherer, MD, FACC, FSCCT; William Downey, MD, FACC, FSCAI; AND ...
PDF, (489.15 KB)
Last updated: 2016-02-18
Randomized Trial of Conventional Transseptal Needle  Versus Radiofrequency Energy Needle Puncture for Left  Atrial Access (the TRAVERSE –LA Study)
Authors: Jonathan C. Hsu, Nitish Badhwar, Edward P. Gerstenfeld, Randall J. Lee, Mala C. Mandyam, Thomas A. Dewland, Kourtney ...
PDF, (112.29 KB)
Last updated: 2016-03-22
Accuracy and Procedural Characteristics of Standard  Needle Compared with Radiofrequency Needle  Transseptal Puncture for Structural Heart Interventions
Authors: Gaurav Sharma MD, Gagan D. Singh MD, Thomas W. Smith MD, Dali Fan MD, Reginald I. Low MD ...
PDF, (140.21 KB)
Last updated: 2016-03-22
The use of a radio frequency needle improves the safety and efficacy of transseptal puncture for atrial   fibrillation ablation
Authors: Roger A. Winkle, MD, FHERS, R. Hardwin Mead, MD, FHRS, Gregory Engel, MD, Rob A. Patrawala, MD
PDF, (124.31 KB)
Last updated: 2016-06-09
Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radio frequency energy
Authors: Stéphane Fromentin, Jean-François Sarrazin, Jean Champagne, Isabelle Nault, François Philippon, Franck Molin, Louis Blier, Gilles O’Hara
PDF, (87.76 KB)
Last updated: 2016-06-09
Radiofrequency Perforation and Conventional  Needle Percutaneous Transseptal Left Heart Access:  PathologicalFeatures
Authors: Gruschen R. Veldtman,¹ Gregory J. Wilson,¹ MD, Alejandro Peirone,¹ MD, Amanda Hartley,² Marvin Estrada,¹ Gunnar Norgard,¹ MD, PhD, ...
PDF, (276.22 KB)
Last updated: 2016-07-05

 

DuoMode™ Cable

See the radiofrequency NRG® Transseptal Needle on your mapping system

 

The DuoMode™ Cable provides streamlined connections between the radiofrequency NRG® Transseptal Needle, the Baylis RF Puncture Generator, and your mapping system.

When used with the radiofrequency NRG® Transseptal Needle
  • Visualize needle tip
  • Help tag transseptal site
  • Help confirm crossing
  • Streamline workflow


  • ORDERING INFORMATION
    DuoMode™ Cable NRG®
    NRG-E-56-XX-CO
    RFX-BAY-DUO-100A NRG-E-HF-XX-CO
    NRG-E-HF-XX-C1
    NRG-56-XX-CO
    RFX-BAY-DUO-100 NRG-HF-XX-CO
    NRG-HF-XX-C1

     


    RFP-100A RF Generator

    The Radiofrequency Puncture Generator is different from cardiac ablation generators.  Instead of creating ablations, our generator is designed specifically for creating controlled punctures using radiofrequency (RF) energy.


    TorFlex™ Transseptal Guiding Sheath

    The Torflex™ Transseptal Guiding Sheath is designed to be smooth and controlled. It advances smoothly across the septal tissue into the left atrium,it provides controlled movements in the left atrium due to its high torquability .


    Connector Cable (RFP-102)

    This push-lock connector provides for the quick and easy connection of the radiofrequency NRG® Transseptal Needle to the Baylis Medical RF Puncture Generator.


    BMC Footswitch Pedal

    The optional footswitch pedal allows the physician to directly control the application of RF energy from the RFP-100A RF Puncture Generator.

     


    The radiofrequency NRG® Transseptal Needle is compatible with standard transseptal sheath & dilator systems. It comes in a number of different configurations. The various curve options mimic those of conventional needles.


     

    Radiofrequency NRG® Transseptal Needle Length
    Curve 0                       
    Curve 1      Compatible Transseptal Sheaths                      
           
    56 cm NRG-56-32-C0*       - 6F Small Anatomy
    Fixed Curve
    48 cm
           
    71 cm NRG-71-C0 NRG-71-C1 8F or 8.5F
    Fixed Curve
    63 cm
           
    89 cm NRG-89-C0 NRG-89-C1 8F or 8.5F
    Fixed Curve
    81 cm

    8F or 9F
    Steerable Curve
    67 cm

           
    98 cm NRG-98-C0 NRG-98-C1

    8.5F
    Steerable Curve
    71 cm

    *compatible with 0.032” dilator systems; proximal gauge 19 ga; distal gauge 22 ga.

     

    • Proximal Gauge: 18 ga
    • Distal Gauge: 21 ga
    • The curves of the radiofrequency NRG® Transseptal Needles mimic those of conventional needles
    • Inner lumen for fluid injection and pressure waveforms
    • Electrically insulated