TORONTO, September 28, 2017—More physicians will soon be evaluating an innovative radio frequency (RF) needle developed by Baylis Medical Company Inc. as part of a cross-Canada clinical trial in people with atrial fibrillation (AF). It is the most common heart arrhythmia abnormality and accounts for the majority of arrhythmia-related emergency room visits and hospital admissions.
Previous studies have demonstrated that the RF needle can be faster, safer and more effective than a mechanical needle for unrelated procedures. Positive results from the CANet study would complement and expand this growing body of evidence.
The 150-patient, multi-centre randomized controlled trial is being sponsored by the Cardiac Arrhythmia Network of Canada (CANet), a national research network that brings together health care professionals, academia, government, industry, not-for-profit organizations, and patients to evaluate and put into practice innovative technologies that improve patient care. The study is one of several CANet-supported projects aimed at reducing AF-related emergency department visits and hospitalization, and the latest in a series of such projects in which Baylis has collaborated.
“Baylis is excited to be partnering once again with CANet, which shares our passion for improving patient care and working with hospitals to facilitate the adoption of safe and effective technologies,” says Kris Shah, President of Baylis Medical, which is providing local physicians with its commercial product and training on how to use it. “Access to CANet’s leading-edge network of investigators allows us to introduce our therapies to even more hospitals, and bring relief to patients, faster.”
Dr. Jason Andrade, the study’s principle investigator, says “Given the number of patients suffering with atrial fibrillation, and the significant healthcare costs associated with managing it, there is a critical need for innovative minimally invasive cardiac procedures that improve patient outcomes without increasing healthcare costs”.
“In August, Dr. Peter Leong-Sit at London Health Sciences became the first physician in this trial to use the Baylis left atrial access equipment, which included the Baylis RF needle, and the surgery was a success,” says Dr. Andrade, Director of Electrophysiology at Vancouver General Hospital.
The clinical study is evaluating two different technologies for accessing the left atrium, which is required for AF ablation procedures as well as the treatment of certain structural heart diseases. One technology is Baylis’ NRG® Transseptal Needle, a blunt-tipped electrode that delivers a short and a highly focused RF energy pulse, allowing a puncture that is more predictable and has the potential to minimize complications. Researchers will also evaluate a procedure where heart rhythm specialists push a sharp, mechanical needle to puncture the tissue. This traditional technique has been demonstrated in comparative clinical studies to be more time-consuming and to lead to complications, such as cardiac tamponade. Procedural complications may result in longer hospital stays and higher per-patient costs.
This will be the first study evaluating the use of Baylis’ Transseptal equipment during a special type of atrial fibrillation procedure that uses a cryoablation balloon catheter to ablate tiny areas in the heart that cause rapid and irregular heartbeats.
Dr. Allan Skanes, CANet’s AF Theme Leader and Director of the London Heart Rhythm Program, has described the Baylis technology as a “slicker and more useful version of the old sharp needle technique” that gives physicians greater control and precision in crossing the septum. Baylis’ product is designed and manufactured in Canada, and cleared for use in several jurisdictions, including Canada, the U.S., EU and Japan.
CANet’s Scientific Director and CEO Dr. Anthony Tang says the study serves as an example of how clinicians and industry partners can work together to improve patient outcomes and enhance productivity in the healthcare system.
“We hope from this study to demonstrate that by treating patients earlier in their disease, we can potentially reduce the risk of stroke and other heart problems from occurring later. The goal is to see this surgical intervention become a frontline treatment for more patients in Canada, and around the world.” says Dr. Tang.
The early release of Baylis’ NRG® Transseptal Needle was made possible, in part, by a repayable matching contribution of $15.2 million from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) through its Advanced Manufacturing Fund.
“We are pleased to match Baylis’ investment to accelerate the development and commercialization of the first-in-Canada medical devices that will be used by doctors during heart procedures,” says the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for FedDev Ontario. “Such innovative and transformative products are expanding international markets for made-in-Canada technologies that have a positive impact on patients around the world.”
The Cardiac Arrhythmia Network of Canada (CANet) is a not-for-profit organization dedicated to transforming Canada’s arrhythmia health care system through integrated trans-disciplinary research and development. The network’s strategy is to invent, prove, and implement innovative solutions to enable patients to take ownership and co-manage their arrhythmia health. CANet is funded by the federal government’s Networks of Centres of Excellence (NCE), Canada’s flagship science and technology program.
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.
IJason G Andrade, MD, Marc Dubuc, MD, Peter G Guerra, MD, Laurent Macle, MD, Lena Rivard, MD, Denis Roy, MD, Mario Talajic, MD, Bernard Thibault, MD, and Paul Khairy, MD, PhD. Cryoballoon Ablation for Atrial Fibrillation, Indian Pacing Electrophysiology Journal. 2012. Mar-Apr; 12(2): 39–53.
IIWinkle RA, Mead RH, Engel G, Patrawala RA. The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablation. Heart Rhythm. 2011 Sep;8(9):1411-5.
Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5): e000428.
PRM-00245 EN J-1,2,3 V-2 © Baylis Medical Company Inc., 2017. 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 and the Baylis Medical logo are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. 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. Patents pending and/or issued.