TORONTO, May 2, 2019 – Baylis Medical announced today the U.S. launch and first clinical use of its ExpanSure™ Transseptal Dilation System, used in a left-atrial appendage (LAA) closure case performed in Cleveland, Ohio.
The ExpanSure dilator combines a sheath and dilator into a single tool, and facilitates larger dilation compared to a standard fixed curve sheath. The larger dilation optimizes left-heart procedures such as LAA closure and balloon ablation for atrial fibrillation, which require a large sheath to cross the heart’s septum from the right atrium.
“Crossing a 14 F sheath across the septum is often challenging, and, in certain cases, additional devices are needed to facilitate left-atrial access. Research has shown that introducing additional dilation devices may result in adverse events to the patient,” said Dr. Oussama Wazni, Section Head of Electrophysiology at the Cleveland Clinic, who performed the first U.S. ExpanSure dilator clinical case. “In addition, clinical evidence has shown that the dilator-sheath transition found in typically-used devices can cause septal tissue to get caught, resulting in difficulty crossing the septum.”
The ExpanSure dilator is designed without the traditional dilator-sheath transition, aiming to eliminate use of added force to achieve crossing. The device features a 12.5 F outer diameter, which pre-dilates the transseptal puncture to greater degree than typically-used devices. This facilitates smoother large sheath introduction to the left atrium. Its 0.035” inner diameter allows physicians to use their preferred wire without having to exchange for a compatible dilator.
“Baylis is proud to offer a device uniquely designed to optimize transseptal access, allowing the physician’s primary focus to remain on delivering the necessary therapy to the patient,” said Robert Harrison, Director of Research and Development, Cardiology at Baylis Medical. “We are delighted to have partnered with Dr. Wazni and the Cleveland Clinic for this successful first clinical use.”
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-00452 EN J-1 V-2 © Baylis Medical Company Inc., 2018. ExpanSure 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.