FDA Clearance For da Vinci Vessel Sealer: CE Mark Next?

Abstract

Robot-assisted surgery specialist Intuitive Surgical, Inc. has announced that it received FDA clearance to market its EndoWrist® One™ Vessel Sealer instrument for use with the da Vinci® Si™ Surgical System.

The Endowrist One Vessel Sealer

The EndoWrist® One Vessel Sealer is a wristed, single-use instrument intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist One Vessel Sealer enables da Vinci Si surgeons  to fully control vessel sealing, while providing the benefits of da Vinci Surgery — enhanced surgical precision, control and stability and 3D HD visualization.

With the purchase of a dedicated radio frequency energy generator, the EndoWrist One Vessel Sealer is compatible with all da Vinci Si Surgical Systems.

The da Vinci Surgical System consists of an ergonomic surgeon console or consoles, a patient-side cart with three or four interactive robotic arms, a high-performance vision system and proprietary EndoWrist instruments.

Company comments

Gary Guthart, CEO, Intuitive Surgical Inc., stated, “We are pleased to start 2012 with this clearance for our EndoWrist One Vessel Sealer. We plan to initiate a controlled rollout of this product in the US in the first quarter of 2012, while also submitting for CE Mark.”

Intuitive®, Intuitive Surgical® , da Vinci® , da Vinci® S™, da Vinci® S™ HD Surgical System, da Vinci® Si™, da Vinci® Si-e™, EndoWrist®, EndoWrist® One™, Single-Site™, DVSTAT® and InSite® are trademarks or registered trademarks ofIntuitive Surgical, Inc.

Source: Intuitive Surgical Inc