First MitraClip™ Procedure Performed Using the All-in-One VersaCross™ Transseptal Solution

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The first MitraClip™ procedure was performed using the VersaCross™ Transseptal Solution was performed by Dr. William Gray, System Chief of Cardiovascular Diseases for Main Line Health, and president, Lankenau Heart Institute, in Wynnewood, Pennsylvania. 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.

“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.

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