TORONTO, Sept. 28, 2017 /PRNewswire/ - 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.ii 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.iii 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.iv Procedural complications may result in longer hospital stays and higher per-patient costs.

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