TORONTO, MAY 8, 2018 - A recent study published in Heart and Vessels has found that the use of the Baylis Medical NRG® radiofrequency (RF) Transseptal Needle for transseptal punctures was linked to a 40% lower incidence of silent acute cerebral embolism in atrial fibrillation (AF) ablation procedure patients.1
The study publication follows a consensus statement recently revised by Heart Rhythm Society and other international societies which suggests that, though the long-term impact of silent cerebral embolism needs investigation, physicians should take the necessary measures to avoid it.2
These are the first study results to find that a lower incidence could be associated with the type of transseptal needle chosen for ablation procedures.
The study compared the post-procedural MRI scans of 232 patients where AF ablation was done using either the NRG® needle or a mechanical needle. Authors suggest there were two differences between the procedures that may contribute to lower risk of silent cerebral embolism.
Advancing the sharp tip of a mechanical needle through a plastic sheath and dilator often creates plastic particles, which, if entering the bloodstream, may result in embolic material being transferred into the patient's body. The blunt-tipped RF needle does not produce this skiving effect.
In addition, the study showed a 14-minute shorter mean procedure time when using the NRG® needle, which, as per the authors, could contribute to the lower incidence of silent cerebral embolism. The study authors also suggest the shorter procedure time could lead to cost efficiencies for electrophysiology labs.
"These study findings join the large body of evidence which confirms that using the NRG needle will result in a more predictable procedure and outcome for physicians," said Gareth Davies, Ph.D., Research and Development Manager at Baylis Medical. "This is part of our larger focus on continually identifying the challenges faced by physicians in order to develop innovative solutions to meet the needs of their patients."
The research findings
were published in April 2018.
About Baylis Medical Company Inc.
Baylis Medical develops and markets high-technology medical devices used in the fields of electrophysiology, interventional cardiology, interventional radiology, and spine. Our vision is to develop and market innovative medical therapies while Improving the Lives of People Around the World. The company has offices in Montreal and Toronto (Canada), Boston (USA), London (UK), and Munich (Germany). For more information, visit www.baylismedical.com.
Tokuda et al. Radiofrequency Needle for Transseptal Puncture is associated with Lower Incidence of Thromboembolism during Catheter Ablation of Atrial Fibrillation: Propensity score-matched analysis. Heart and Vessels. 10 April 2018. [Epub ahead of print]
Calkins et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444.
PRM-00320 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2018. NRG and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. Patents Pending and/or issued. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use.