Baylis Medical announced today the first Arctic Front™ Advance Cryoballoon procedures 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 wire, which acts as both puncture device and exchange rail.
The puncture wire features Baylis' signature RF puncture technology, which facilitates controlled and precise transseptal procedures.
The first cryoballoon cases were performed by Dr. Dan Musat, cardiac electrophysiologist at The Valley Hospital in Ridgewood, New Jersey, US.
"Balloon ablation cases have an added layer of complexity as they require a sturdy exchange rail to achieve left-atrial access of large bore ablation catheters," said Dr. Musat. "The VersaCross solution provides strong support for these large catheters, allowing them to smoothly follow the wire's path into the left atrium for delivery of therapy."
The device has a 0.035" exchange rail, functioning as an exchange wire once left-atrial access is achieved, streamlining procedures and eliminating the need for additional devices. The VersaCross solution also includes the first shapeable sheath and dilator, further enabling cardiologists to achieve transseptal punctures at the optimal location on the septum.
Dr. Suneet Mittal, Director of Electrophysiology and Cardiac Research at Valley and Medical Director of the Snyder Center for Comprehensive Atrial Fibrillation said: "A number of device exchanges are typically required throughout an ablation procedure, to gain transseptal access and deliver therapy. With every exchange comes added risk to the patient. Given that the VersaCross solution acts as puncture device and exchange rail, it eliminates the need to introduce these devices individually into the body, while still executing smooth and precise transseptal access."
"Our aim with the VersaCross solution was to allow physicians to focus on the delivery of therapy, by developing a device that builds on their ability to efficiently navigate the common complexities of transseptal access," said J.P. Urbanski, PhD, who led the development of the VersaCross solution at Baylis Medical.
The VersaCross solution is available in J-Tip and Pigtail wire configurations. The device is expected to launch early 2020.