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Devices Interventional Cardiology

 News Release - December 1, 2020

Study Finds TMVR Procedural Efficiency with use of the VersaCross(R) RF Transseptal Solution

MitraClip™ Guide delivery achieved in under 7.5 minutes1

TORONTO, Dec. 1, 2020 -- (Healthcare Sales & Marketing Network) - A recent publication demonstrated procedural efficiency for MitraClip™ transcatheter mitral valve repair (TMVR) with use of the VersaCross® RF Transseptal Solution, reporting guide delivery from femoral access in under 7.5 minutes1.

The VersaCross solution features a single radiofrequency (RF)-tipped wire used to introduce the transseptal sheath into the superior vena cava (SVC), gain transseptal access and act as an exchange wire in the left atrium to facilitate MitraClip Guide delivery. Typically, this process involves exchanging multiple devices to achieve and maintain transseptal access. The VersaCross platform is the world's first, exchangeless solution for access-to-delivery of left heart therapy devices.

The publication, titled "Initial Clinical Experience with VersaCross Transseptal System for Transcatheter Mitral Valve Repair" was published in Catheterization and Cardiovascular Interventions, in November 2020. The research was led by Dr. Anita W. Asgar, interventional cardiologist in the Cardiology Division of the Montreal Heart Institute.

Initial findings concluded procedural efficiency, citing 3.3 minutes to gain transseptal access and a subsequent 3.8 minutes to achieve MitraClip Guide delivery, with a 100% success rate. Previously published data cited 16 minutes to gain transseptal access with use of other transseptal solutions2. Additionally, researchers noted a reduced number of wire exchanges required, with the ability to reposition puncture location on the fossa ovalis without the need to rewire.

"The VersaCross platform has improved efficiency in my practice. The exchangeless technology allows me to perform precise puncture and delivery of MitraClip guide in under 8 minutes, allowing for safer, more efficient and predictable procedures for my patients," said Dr. Asgar.

The VersaCross solution can be customized to meet physician preference and the patient's needs. This includes J-Tip and Pigtail wire configurations, as well as tailor-built fixed and steerable sheath options.

"Working closely with leading physicians, we identified a clinical need for technology that allows for controlled precision and secure, effortless delivery while minimizing procedural steps. We are thrilled to learn that these researchers experienced what we set out to design to meet the needs of both physicians and patients," said J.P. Urbanski, PhD, who led the development of the VersaCross solution at Baylis Medical.

To learn more about the VersaCross platform and to view complete study highlights, click here.

About Baylis Medical

Baylis Medical is a leader in the development and commercialization of innovative medical devices in the fields of cardiology and spine. 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.

1 Using the VersaCross® RF Transseptal Solution from femoral access; based on 3.3 min for TSP and 3.8 min for subsequent MitraClip guide exchange.

2 Not based on head-to-head comparison, Maisano, et al. DOI: 10.1002/ccd.29365

PRM- 00660 EN J-1,2,3 V-1 © Baylis Medical Company Inc., 2020. VersaCross 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


Source: Baylis Medical

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