Press Release
Randomized Controlled Trial Finds NRG® Transseptal Needle Leads to Shorter Procedure Times, Reduced Radiation Exposure
November 05, 2019
TORONTO, NOVEMBER 5, 2019 – A randomized controlled trial has found that use of Baylis Medical’s NRG® Transseptal Needle results in shorter time in achieving transseptal access, less transseptal attempts, and reduced exposure to radiation, compared to use of a conventional transseptal needle.
The study, entitled Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation (the CRYO-LATS Study), was presented at the recent Transcatheter Therapeutics Conference (TCT) in San Francisco, by Dr. Jason Andrade, Director of Cardiac Electrophysiology at the Vancouver General Hospital.
The study was a multicenter prospective, single-blind, randomized controlled trial (RCT), in which 135 patients with symptomatic paroxysmal atrial fibrillation (AF) underwent pulmonary vein isolation using a novel large bore cryoballoon system. Researchers performed a transseptal puncture using either a conventional transseptal needle requiring mechanical force to cross the septum, or the NRG needle, which uses radiofrequency (RF) energy for crossing. Researchers found that the median transseptal puncture time using the NRG needle was significantly shorter.
Further, use of the NRG needle resulted in fewer attempts to puncture the septum than with the conventional needle. Researchers also observed a trend for lower exposure to radiation for the patient and catheterization lab staff in cases where the NRG needle was used.
“With the increasing need for left-atrial access in cardiac procedures, it is more important than ever to evaluate the effectiveness and safety associated with transseptal tools we have available,” said Dr. Andrade. “The study’s results indicate the ease of use, reliability and effectiveness of the NRG needle when partnered with a Baylis sheath and ProTrack™ Pigtail Wire, and as compared to the standard mechanical transseptal alternatives.”
The CRYO-LATS Study was conducted in partnership with the Cardiac Arrhythmia Network of Canada (CANet).
“AF is the most common arrythmia observed in clinical practice,” said Dr. Anthony Tang, Chief Executive Officer and Scientific Director of CANet. “As such, it is critical to continually seek advancement and effectiveness in the care we provide these patients. We are pleased to have collaborated in this trial.”
Meghal Khakhar, Vice President of Regulatory and Scientific Affairs at Baylis Medical added: “At Baylis, our priority is to develop devices that meet the evolving needs of patients. We are pleased to see that, once again, the NRG needle is shown to be the gold standard in achieving transseptal access.”
About Baylis Medical
Baylis Medical is a leader in the development and commercialization of innovative medical devices in the field of cardiology, with a focus on left-heart access. Headquartered in Canada, and with offices world-wide, our clinical solutions have been Improving the Lives of People Around the World for over 30 years. For more information, visit www.baylismedical.com and connect with us on Twitter, LinkedIn and Instagram.
PRM-00521 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2019. NRG, ProTrack and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. Other trademarks are property of their respective owners. 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.
The study, entitled Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation (the CRYO-LATS Study), was presented at the recent Transcatheter Therapeutics Conference (TCT) in San Francisco, by Dr. Jason Andrade, Director of Cardiac Electrophysiology at the Vancouver General Hospital.
The study was a multicenter prospective, single-blind, randomized controlled trial (RCT), in which 135 patients with symptomatic paroxysmal atrial fibrillation (AF) underwent pulmonary vein isolation using a novel large bore cryoballoon system. Researchers performed a transseptal puncture using either a conventional transseptal needle requiring mechanical force to cross the septum, or the NRG needle, which uses radiofrequency (RF) energy for crossing. Researchers found that the median transseptal puncture time using the NRG needle was significantly shorter.
Further, use of the NRG needle resulted in fewer attempts to puncture the septum than with the conventional needle. Researchers also observed a trend for lower exposure to radiation for the patient and catheterization lab staff in cases where the NRG needle was used.
“With the increasing need for left-atrial access in cardiac procedures, it is more important than ever to evaluate the effectiveness and safety associated with transseptal tools we have available,” said Dr. Andrade. “The study’s results indicate the ease of use, reliability and effectiveness of the NRG needle when partnered with a Baylis sheath and ProTrack™ Pigtail Wire, and as compared to the standard mechanical transseptal alternatives.”
The CRYO-LATS Study was conducted in partnership with the Cardiac Arrhythmia Network of Canada (CANet).
“AF is the most common arrythmia observed in clinical practice,” said Dr. Anthony Tang, Chief Executive Officer and Scientific Director of CANet. “As such, it is critical to continually seek advancement and effectiveness in the care we provide these patients. We are pleased to have collaborated in this trial.”
Meghal Khakhar, Vice President of Regulatory and Scientific Affairs at Baylis Medical added: “At Baylis, our priority is to develop devices that meet the evolving needs of patients. We are pleased to see that, once again, the NRG needle is shown to be the gold standard in achieving transseptal access.”
About Baylis Medical
Baylis Medical is a leader in the development and commercialization of innovative medical devices in the field of cardiology, with a focus on left-heart access. Headquartered in Canada, and with offices world-wide, our clinical solutions have been Improving the Lives of People Around the World for over 30 years. For more information, visit www.baylismedical.com and connect with us on Twitter, LinkedIn and Instagram.
PRM-00521 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2019. NRG, ProTrack and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. Other trademarks are property of their respective owners. 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.
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