First In-Human Experience with the Exchangeless VersaCross Connect™ LAAC Access Solution

Procedural simplification of left atrial appendage occlusion using the VersaCross connect system: First in-human experience, study led by Nils Perrin, MD, Cameron McAlister, MD, Michael Tsang, MD, Blandine Mondésert, MD, Réda Ibrahim MD, Jaqueline Saw, MD

VersaCross Connect™ improved WATCHMAN FLX™ LAAC procedural efficiency and saved six steps compared to the standard needle-based workflow, with no procedural complications.*

Study Highlights Using the VersaCross Connect™ LAAC Access Solution

Improved Procedural Efficiency

–   Eliminated six steps from WATCHMAN FLX™ LAAC procedures compared to the standard needle-based workflow
–   Short overall procedure time: 31 minutes (± 6.3)
–   Short interval between LAA access and device deployment: 12.2 minutes (± 1.9)

Reduced Risk
–   LAAC was successful in 100% of patients, with no procedural complications*
–   Streamlining LA access and simplifying LAAC procedures by eliminating multiple sheath exchanges can reduce the risk of air embolism and perforation

Zero Exchange WATCHMAN FXD Curve™ Access System Delivery

* Nine consecutive cases of WATCHMAN FLX™ LAAC were performed using the VersaCross Connect™ LAAC Access Solution.
The VersaCross Connect™ Transseptal Dilator is for use with a 12F ID WATCHMAN™ Access Sheath that is 75 cm in length, specifically: WATCHMAN™ Access System [Models: M635TU40060, M635TU10060, M635TU20060];
WATCHMAN™ TruSeal™ Access System [Models: M635TU70010, M635TU70040, M635TU70020];
WATCHMAN FXD Curve™ Access System [Models: M635TU80010, M635TU80020].

PRM-01019 EN J-1 V-1 © 2023 Boston Scientific Corporation or its affiliates. All rights reserved. All trademarks are property of their respective owners. Patents Pending and/or issued. CAUTION: U.S. Federal law restricts these devices to sale by or on the order of a physician. Rx only. Prior to use, please see the complete Instructions for Use for more information on Indications, Contraindications, Warnings, Precautions, Adverse events, and Operator's instructions. 
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VersaCross Connect™ LAAC Access Solution IFU