Dedicated RF transseptal solutions

Over 2 million patients treated globally^*

With over a decade of experience in dedicated RF technology, we've redefined transseptal

The VersaCross™ RF Transseptal Platform was designed to simplify your workflow and improve puncture efficacy.¹ Every VersaCross Solution includes the 3-in-1 VersaCross RF Wire, with an optimized electrode design for precise crossing, and a reinforced dilator with TRUform™ Shapeable Technology to optimize handling and positioning for various anatomies. The RFP-100A RF Puncture Generator** facilitates controlled, targeted transseptal punctures via the delivery of proprietary RF energy waveforms, while OMNIviz™ Technology enhances visualization on fluoroscopy, ultrasound, and electrical anatomical mapping.

Explore the technology behind each component of our dedicated VersaCross RF Transseptal Platform below.

The VersaCross RF Wire has been shown to facilitate more consistent site-specific crossing of the interatrial septum, allowing the operator to optimize transseptal puncture location in any anatomy.^2,3,4,5,6 Optimized electrode design and generator settings may improve puncture efficacy, minimize thermal injury, and eliminate embolic coring risk, while the use of electrified guidewires for transseptal puncture has been associated with damage to the guidewire and dilator, as well as risks of thrombus, thermal injury and tissue scaring.^1,7

Clinical evidence

Reduced risk of complications associated with exchanges

The 3-in-1 VersaCross RF Wire has been shown to facilitate left heart access and therapy sheath delivery with fewer device exchanges than a mechanical or RF transseptal needle-based workflow by serving as a starter wire, RF puncture device, and exchange guidewire.^8,9,10 As a result, the risk of complications associated with exchanges, such as silent cerebral events, may be reduced.^2,8,9,11,12

Clinical evidence

Reinforced transseptal dilator

TRUform Shapeable Technology

Reinforced with TRUform Shapeable technology, the VersaCross Transseptal Dilator facilitates a familiar handling experience to a needle-based transseptal system and retains your desired curve. Reshape the dilator within your sheath to optimize transseptal assembly positioning for various anatomies.^†,2

Smooth dilator-to-sheath transition

The VersaCross Transseptal Dilator was specially designed to provide a minimal, smooth dilator-to-sheath transition for sleek advancement into the left atrium. The smooth transition between VersaCross Connect™ Dilators and compatible therapy delivery sheaths may reduce snagging on the fossa ovalis during crossing.^†

Dedicated RF puncture generator

Proprietary RF energy waveforms for targeted punctures

The RFP-100A RF Puncture Generator^** was designed to create small, targeted transseptal punctures via the delivery of proprietary RF energy waveforms. The generator enables shorter RF activation time, while built-in safety features limit the voltage, current, and power. Use of the RFP-100A RF Puncture Generator^** with the VersaCross RF Wire has been shown to result in smaller puncture sites and improved transseptal puncture consistency when compared to electrified guidewires or needles.^1,4,7

Clinical evidence

Comparing ex vivo transseptal puncture sites utilising an electrified needle at 10W, 20W, and 30W, to a successful puncture site utilising the VersaCross Wire at 10W.

Fewer and lower energy applications required

Achieve successful transseptal puncture with fewer and lower energy applications required. In a comparison study, an electrified transseptal needle required 30 W to achieve 91% transseptal puncture success, failing to puncture at 10 W and 20 W, while the VersaCross Access Solution achieved 100% transseptal puncture success with only one energy application of approximately 10 W and zero incidence of tissue coring. Adversely, the electrified needles were associated with tissue charring, larger septal defects and tissue coring in 57% of punctures.¹

Clinical evidence

Enhanced visualization with OMNIviz Technology

VersaCross Access Solution under fluoroscopy.

Radiopaque

The VersaCross Wire and Dilator are radiopaque so you can visualize your entire solution on fluoroscopy.

VersaCross Access Solution on ultrasound.

Echogenic

Reliably locate your VersaCross Wire and Dilator on ultrasound to reduce or eliminate fluoroscopy time and radiation exposure.^9,10,13,14

Mapping

Connect to the DuoMode™ Cable to track and mark the VersaCross RF Wire’s electrode tip on your preferred mapping system.^‡

VersaCross product portfolio

VersaCross Connect Access Solution for FARADRIVE™

For use with the FARAPULSE™ Pulsed Field Ablation System. Connect VersaCross technology with the FARADRIVE Steerable Sheath^§ for an integrated zero exchange left heart access workflow.

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VersaCross Connect LAAC Access Solution

For use with WATCHMAN™ Access Systems. Connect VersaCross technology with compatible WATCHMAN sheaths^‖ for zero exchange left heart access.

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VersaCross Access Solution

Enables exchangeless access-to-delivery of left heart therapy devices.

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VersaCross Steerable Access Solution

Enables exchangeless access-to-delivery of left heart therapy devices with high precision steering.

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VersaCross Large Access Solution

Enables exchangeless access, dilation, and delivery of large therapy sheaths.

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VersaCross Connect Access Solution for POLARSHEATH™

For use with the POLARx™ Cryoablation System. Connect VersaCross technology with the POLARSHEATH Steerable Sheath^¶ for zero exchange left heart access.

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Request a sales rep

Connect with your local representative to discuss Boston Scientific transseptal access solutions.

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VersaCross Detail Package

View product specifications, clinical evidence, and regulatory, reimbursement, and ordering information.

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EDUCARE homepage displayed on MacBook laptop.

EDUCARE training

View transseptal access educational content on-demand.

Access EP EDUCARE content Access IC EDUCARE content

* Over two million patients globally have been treated using the VersaCross™ Transseptal Solutions and NRG™ Needles, inclusive of lifetime sales.

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

† Bench testing or pre-clinical study results may not necessarily be indicative of clinical performance. The testing was performed by or on behalf of Boston Scientific. Data on file.

‡ Consult your mapping system’s user manual for connectivity and configuration instructions prior to DuoMode Cable use.

§ The VersaCross Connect Transseptal Dilator is for use with a 13F (4.31 mm) ID FARADRIVE™ Steerable Sheath which is 74cm in length, specifically, model: M004PF21M402 (US).

‖ The VersaCross Connect Transseptal Dilator is for use with a 12F (4.09 mm) ID WATCHMAN Access Sheath that is 75 cm in length or the WATCHMAN TruSteer™ Access Sheath that is 67 cm in length, specifically: WATCHMAN Access System [Models: M635TU40060, M635TU10060, M635TU20060]; WATCHMAN TruSeal™ Access System [Models: M635TU70010, M635TU70040, M635TU70020]; WATCHMAN FXD Curve™ Access System [Models: M635TU80010, M635TU80020]; WATCHMAN TruSteer Access System [Model: M635TU90050].

¶ The VersaCross Connect Transseptal Dilator is for use with a 12F (4.04 mm) ID POLARSHEATH Steerable Sheath that is 68 cm in length, specifically, model: M004CRBS3150 (US).

References:

Knight BP, Wasserlauf J, Al-Dujaili S, Al-Ahmad A. Comparison of transseptal puncture using a dedicated RF wire versus a mechanical needle with and without electrification in an animal model. J Cardiovasc Electrophysiol. 2023. doi:10.1111/jce.16111
Sayah N, Simon F, Garceau P, et al. Initial clinical experience with VersaCross transseptal system for transcatheter mitral valve repair. Catheter Cardiovasc Interv. 2021;97(6):1230-1234. doi:10.1002/ccd.29365
Doshi SN, Savvoulidis P, Mechery A, et al. VersaCross Transseptal System for Mitral Transcatheter Edge-To-Edge Repair with the PASCAL Repair Platform. Struct Heart. 2023;In Press.
Berggren K, Lampert T, Janardhan AH. Improved left atrial catheterization efficiency and consistency using a novel steerable transseptal puncture sheath [published online ahead of print, 2023 Oct 5]. Indian Pacing Electrophysiol J. 2023;S0972-6292(23)00101-8. doi:10.1016/j.ipej.2023.10.001
Andrade JG, Macle L, Bennett MT, et al. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022;65(2):481-489. doi:10.1007/s10840-022-01277-y
Smelley MP, Shah DP, Weisberg I, et al. Initial experience using a radiofrequency powered transseptal needle. J Cardiovasc Electrophysiol. 2010;21(4):423-427. doi:10.1111/j.1540-8167.2009.01656.x
Wasserlauf J, Knight BP. Comparing the safety and effectiveness of dedicated radiofrequency transseptal wires to electrified metal guidewires. J Cardiovasc Electrophysiol. 2022;33(3):371-379. doi:10.1111/jce.15341
Inohara T, Gilhofer T, Luong C, Tsang M, Saw J. VersaCross radiofrequency system reduces time to left atrial access versus conventional mechanical needle. J Interv Card Electrophysiol. 2022;63(1):9-12. doi:10.1007/s10840-020-00931-7
Dewland TA, Gerstenfeld EP, Moss JD, et al. Randomized Comparison of a Radiofrequency Wire Versus a Radiofrequency Needle System for Transseptal Puncture. JACC Clin Electrophysiol. 2023;9(5):611-619. doi:10.1016/j.jacep.2022.10.017
Whitler C, McClellan B, Patel H, et al. Improved left atrial appendage closure procedural efficiency using radiofrequency transseptal wire system [published online ahead of print, 2023 Jan 10]. Catheter Cardiovasc Interv. 2023;10.1002/ccd.30550. doi:10.1002/ccd.30550
Deneke T, Nentwich K, Schmitt R, et al. Exchanging Catheters Over a Single Transseptal Sheath During Left Atrial Ablation is Associated with a Higher Risk for Silent Cerebral Events. Indian Pacing Electrophysiol J. 2014;14(5):240-249. Published 2014 Oct 6. doi:10.1016/s0972-6292(16)30795-1
Harada M, Motoike Y, Nomura Y, et al. Factors associated with silent cerebral events during atrial fibrillation ablation in patients on uninterrupted oral anticoagulation. J Cardiovasc Electrophysiol. 2020;31(11):2889-2897. doi:10.1111/jce.14716
Demo H, Aranda C, Razminia M. Fluoroless left atrial access for radiofrequency and cryoballoon ablations using a novel radiofrequency transseptal wire [published correction appears in J Interv Card Electrophysiol. 2022 Mar 29;:]. J Interv Card Electrophysiol. 2022;64(1):183-190. doi:10.1007/s10840-022-01157-5
Salam T, Wilson L, Bohannan S, Morin M. Safety and Effectiveness of a Novel Fluoroless Transseptal Puncture Technique for Lead-free Catheter Ablation: A Case Series. J Innov Card Rhythm Manag. 2020;11(4):4079-4085. Published 2020 Apr 15. doi:10.19102/icrm.2020.110405