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Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.

The Solo Pace Fusion System consists of the following components:

• Fusion Guidewire
• Fusion Ground Pad
• Fusion Connection Cable
• Solo Pace Control System, consisting of the following:
  • Solo Pace Remote Control Module (RCM), packaged with the Fusion Guidewire, Fusion Ground Pad and Fusion Connection Cable
  • Solo Pace External Pulse Generator (EPG) (sold separately)

The Fusion Guidewire is intended to deliver interventional devices into the heart and serve as the pacing conduit when used with the Solo Pace Control system. The Fusion Guidewire is made of stainless steel and includes a pre-shaped pigtail distal tip. The Fusion Guidewire has a diameter of 0.035" (0.89 mm) and a length of 275 cm. The Fusion Guidewire is supplied with a tip insertion tube to help advance the guidewire into a catheter. A PTFE coating covers the shaft for lubricity. The proximal 8mm is uncoated to allow connection of the Fusion Guidewire to the Fusion Connection Cable. The pigtail is coated with silicone for lubricity. The Fusion Guidewire is supplied sterile, non-pyrogenic and is intended for single use only.

The Fusion Ground Pad is a transcutaneous pad placed on the patient to serve as the anode terminal for unipolar pacing via a unique connection to the Fusion Connection Cable. The Ground Pad acts as the return electrode for the pacing signal delivered to the patient's heart through the Fusion Guidewire. The Ground Pad cable is 60 inches (1.5 m) long and the skin contacting surface area is 350 cm².

The Fusion Connection Cable connects the Fusion Guidewire and the Fusion Ground Pad to the Solo Pace Control System (EPG component) in a manner that ensures proper polarity. The Fusion Connection Cable is approximately 60 inches (1.5 m) long.

The Solo Pace Control System RCM is a single use sterile device supplied with the Solo Pace Fusion System. The Solo Pace RCM connects wirelessly with the EPG to allow physician control of the EPG in the sterile field.

The Solo Pace Control System EPG is a reusable, external pulse generator described in detail in its Instructions for Use (IFU). The Solo Pace Control IFU should be reviewed, in its entirety, prior to the use of the Solo Pace Fusion System. Solo Pace Control was cleared for use under K241781.

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