Press Release
First MitraClip™ Procedure Performed Using the All-in-One VersaCross™ Transseptal Solution
September 23, 2019
TORONTO, September 23, 2019 – Baylis Medical announced today the successful first MitraClip™ procedure performed using the VersaCross™ Transseptal Solution. The VersaCross solution is the world’s first all-in-one left-heart access device featuring an atraumatic RF-tipped pigtail wire. The device is designed to achieve left-heart access with controlled precision, while reducing the number of exchanges throughout the procedure by serving as an exchange wire once access is achieved.
The puncture wire features Baylis’ signature RF puncture technology, which aims to facilitate smooth and precise transseptal procedures. The VersaCross solution also includes the first shapeable sheath and dilator, further allowing transseptal punctures to occur at the optimal location on the septum.
The VersaCross™ Transseptal Solution is available in Pigtail and J-tip RF wire configurations.
Performing the first MitraClip procedure using the VersaCross solution was Dr. William Gray, System Chief of Cardiovascular Diseases for Main Line Health, and president, Lankenau Heart Institute, in Wynnewood, Pennsylvania.
“Structural heart procedures requiring transseptal approaches demand a very precise puncture location to optimize therapy delivery. Traditionally, this requires the use of multiple devices in a step-wise method,” said Dr. Gray. “If the optimal location is not achieved on first-pass, we are required to return to the starting point, which involves the time consuming and potentially riskier reintroduction of multiple devices. This new device enables a novel technique which minimizes the need for exchanges and streamlines transseptal access while achieving the optimal puncture location.”
The VersaCross solution has a sturdy 0.035” exchange rail, eliminating the need for additional devices to achieve reliable delivery of large sheaths. It facilitates efficient transseptal procedures by reducing the overall number of device exchanges.
“The VersaCross solution serves transseptal procedures from start to finish, by combining a versatile wire and sheath with the precision of Baylis’ RF puncture technology,” said Robert Harrison, Director of Research and Development, Cardiology, at Baylis Medical. “It is a true embodiment of the Baylis mandate to provide physicians with meaningful advancements in transseptal access, for the sake of improved patient care.”
The VersaCross platform is also available in a J-tip wire and can be paired with a range of sheaths tailored to individual needs. The device is expected to commercially launch early 2020.
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-00511 EN J-1 V-1 © Baylis Medical Company Inc., 2019. 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 for Use.
The puncture wire features Baylis’ signature RF puncture technology, which aims to facilitate smooth and precise transseptal procedures. The VersaCross solution also includes the first shapeable sheath and dilator, further allowing transseptal punctures to occur at the optimal location on the septum.
Performing the first MitraClip procedure using the VersaCross solution was Dr. William Gray, System Chief of Cardiovascular Diseases for Main Line Health, and president, Lankenau Heart Institute, in Wynnewood, Pennsylvania.
“Structural heart procedures requiring transseptal approaches demand a very precise puncture location to optimize therapy delivery. Traditionally, this requires the use of multiple devices in a step-wise method,” said Dr. Gray. “If the optimal location is not achieved on first-pass, we are required to return to the starting point, which involves the time consuming and potentially riskier reintroduction of multiple devices. This new device enables a novel technique which minimizes the need for exchanges and streamlines transseptal access while achieving the optimal puncture location.”
The VersaCross solution has a sturdy 0.035” exchange rail, eliminating the need for additional devices to achieve reliable delivery of large sheaths. It facilitates efficient transseptal procedures by reducing the overall number of device exchanges.
“The VersaCross solution serves transseptal procedures from start to finish, by combining a versatile wire and sheath with the precision of Baylis’ RF puncture technology,” said Robert Harrison, Director of Research and Development, Cardiology, at Baylis Medical. “It is a true embodiment of the Baylis mandate to provide physicians with meaningful advancements in transseptal access, for the sake of improved patient care.”
The VersaCross platform is also available in a J-tip wire and can be paired with a range of sheaths tailored to individual needs. The device is expected to commercially launch early 2020.
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-00511 EN J-1 V-1 © Baylis Medical Company Inc., 2019. 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 for Use.
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