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The TELLTALE Electrosurgical Guidewire System is indicated for transcatheter electrosurgical traversal and laceration of native and bioprosthetic tissue in patients at risk of coronary obstruction during TAVR.

The TELLTALE system is comprised of the TELLTALE Guidewire, guide catheters and accessories to aid with the preparation, placement, and use of guidewire.

The TELLTALE system consists of the following elements:

• TELLTALE Guidewire
• TELLTALE Pachyderm Guide catheters (for left coronary cusp and for right coronary cusp)
• TELLTALE System Accessories
  • Spring-loaded cable connector
  • Denuder/Kinker
  • Guidewire grippers
  • Insulation envelope
  • Insulation tube
  • Plastic torquers
  • 6F Peel-away introducer
  • Guidewire introducer

The TELLTALE Guidewire has an outer diameter of 0.014" and a working length of 310cm. It is composed of a stainless-steel guidewire covered with an outer insulative polymer layer. The distal tip and proximal end of the guidewire are uninsulated. The TELLTALE Guidewire mid-shaft is provided to the user fully insulated to protect the operator from RF energy when the uninsulated guidewire tip is used for electrosurgical leaflet traversal inside the patient.

The proximal end of the TELLTALE Guidewire, which has no patient contact, is uninsulated and gold-plated to allow for connection to an electrosurgery generator to facilitate the delivery of monopolar RF energy to the cutting surfaces of the guidewire.

The TELLTALE Guidewire is to be used with RF generators that provide continuous wave, monopolar PURE CUT mode energy with power settings of 10 to 50 W (into a rated load of 300 ohms with maximum voltage of 900 V peak or less).

There are two cutting surfaces of the TELLTALE Guidewire:

1. the distal tip for leaflet traversal
2. a mid-shaft cutting location for aortic leaflet laceration.

The mid-shaft of the TELLTALE guidewire is identified by a 10mm gold marker band which is radiopaque. The mid-shaft cutting surface is created by the user by removing the insulative coating after the distal tip is used to traverse through tissue.

There are seven guide catheters specifically shaped to aid in leaflet traversal by allowing physicians to select the traversal location and providing support for TELLTALE Guidewire leaflet traversal. The TELLTALE System is supplied with three boxes; all guide catheters will be in separate shelf cartons, within one box. All seven guide catheters have a usable length of 100cm and an outer diameter of 6.4F.

There are multiple accessories provided to aid with the procedure:

• Guidewire gripper: The guidewire gripper attaches to a standard Y-adaptor and clamps onto the TELLTALE Guidewire to assist with guidewire traction during the procedure.

• Insulation envelope: Insulation envelope is provided for the physician to place the end of the guidewire during the traversal procedure to contain the backend of the guidewire and provide additional insulative protection

• Insulation Tube: An insulation tube is provided for the physician to place on the proximal end of the gooseneck snare during traversal (puncture) of the leaflet to provide insulation. It is also place by the physician on the end of the snared tip of the guidewire during the leaflet laceration procedure to provide insulation to the tip of the guidewire.

• Spring Loaded Connector: A detachable spring-loaded connector cable that plugs into the monopolar receptacle of a compatible RF generator that is used in conjunction with a compatible patient return electrode and allows for a secure insulative connection between the TELLTALE Guidewire and the generator. The detachable connector allows for exchange of catheters over the TELLTALE Guidewire as needed during the procedure.

• Denuder/Kinker: The Denuder/Kinker is provided to (1) create a reproducible denuded or uninsulated, area at the mid-shaft location of the TELLTALE Guidewire for laceration and (2) kink the TELLTALE Guidewire at the lacerating surface to produce the required angle for the leaflet laceration procedure.

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