Randomized Controlled Trial Demonstrates Radiofrequency Transseptal Needle Provides Added Benefits over Conventional Needle

MONTREAL, September 27, 2013—The results of a randomized controlled trial comparing the safety and effectiveness of the radiofrequency NRG^® Transseptal Needle to a conventional mechanical needle were published this month in The Journal of the American Heart Association. Conducted by electrophysiologists at the University of California, San Francisco, the study shows that the radiofrequency NRG^® needle was successful in completing the transseptal puncture in a number of procedures where the conventional needle failed to do so. There was no difference observed in the rate of adverse events. The radiofrequency NRG^® needle also significantly reduced median transseptal procedure time. A further benefit was seen in that the radio frequency NRG^® needle produced less grossly visible plastic shavings (0%) compared to the mechanical needle (33.3%).

The transseptal procedure is commonly part of atrial fibrillation ablation cases. It is a challenging and specialized procedure used to gain access to the left atrium of the heart.

Dr. Gregory Marcus, Director of Clinical Research for the UCSF Division of Cardiology, and senior author of the study, believes the NRG^® needle improves transseptal procedure efficacy and efficiency: “Previous observational studies have suggested that radiofrequency assisted transseptal puncture may provide superior benefits over a regular mechanical needle. Our study provides the first randomized clinical evidence to suggest increased effectiveness and efficiency of the RF needle.”

This randomized, controlled trial included 72 patients undergoing cardiac catheter ablation procedures with a planned transseptal puncture. Subjects were randomized on a 1:1 basis to receive transseptal puncture with either a radiofrequency needle or a conventional needle. The median time to achieve transseptal left atrial access was 68% shorter using the NRG^® needle as compared to the conventional needle (2.3 minutes versus 7.3 minutes, on an intention-to-treat basis). Failure to achieve transseptal access with the assigned needle did not occur with the NRG^® needle, whereas the conventional needle failed on ten occasions (27.8%). In these 10 failed instances, subsequent crossover to the NRG^® needle enabled a successful transseptal procedure. Ex vivo preprocedural testing found that the conventional needle produced visible plastic shavings in one-third of the cases whereas the NRG^® needle did not produce any such plastic shavings.

About Baylis Medical
Baylis Medical develops and markets high-technology medical devices used in the fields of electrophysiology, interventional cardiology, interventional radiology, and spinal procedures. 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.

© Copyright Baylis Medical Company Inc., 2013 Baylis Medical Company Inc. reserves the right to change specifications or to incorporate design changes without notice and without incurring any obligation relating to equipment previously manufactured or delivered. NRG is a trademark or registered trademark of Baylis Medical Company Inc. in the United States of America and/or other countries. Before use, consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use. CAUTION: Federal Law (USA) restricts the use of this device to or by the order of a physician.