Technical Area

1) Device characteristics

• The DSS is a device for sternal repair after sternotomy made of titanium (per the ASTM F67 standard).
• It is non ferrous and non-magnetic in order to allow the patient to undergo Magnetic Resonance Scanning (MRI) after implantation.
• It is considered a permanent implant (intended for implantation for more than 30 days).
• Its mechanical characteristics (elastic modulus) allow it to adapt to the ribs close to the sternum since it can bend without breaking.
• The DSS consists of a single piece of folded metal, consisting of an anterior limb which is placed on the anterior surface of the hemisternum and two lateral limbs, which are introduced into the intercostal space and secured to the posterior surface of the ribs.
• The sternal closure wire sutures are inserted between these two lateral limbs (see implantation technique).

2) Indications for Use

The Device for Sternal Synthesis (DSS) is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.

3) Contraindications

Allergy to titanium or titanium alloy.

4) Precautions

• It is important to follow all the instructions, recommendations and to consider the contraindications and precautions described and inform the patient of the use of the DSS, as applicable;
• Alternative methods, assistance, or devices should always be available before implanting the DSS.
• Surgical procedures utilizing the DSS should be performed by appropriately trained and qualified surgeons having a comprehensive knowledge of the specialized surgical techniques and surgical anatomy.
• The choice of correct patient positioning and the appropriate surgical technique are critical factors which influence the device success and the postoperative therapy.
• It is important not to damage the DSS by hitting or scratching the device before use or during the bending of the limbs after their introduction between the ribs.
• Always check the physical integrity of the DSS as well as its functioning before introducing it.

5) Use

• To use the DSS correctly, always follow these recommendations:
• Stainless steel suture wires for sternal closure must be always used;
• The DSS must be implanted using the appropriate surgical technique.
• For more information about the use of the DSS contact your local distributor or consult the medical literature.

6) Implantation technique

The DSS is designed to be used with commonly used monofilament stainless steel sutures. The device size must be chosen in relation to the sternal anatomical characteristics. It is designed to spread the force applied by the wire sutures over a greater area, thereby reducing the distracting forces applied by patient movement and stabilizing the sternum. For implantation, the desired number of DSS pairs should be assembled and the vertical limbs inserted into the respective intercostal spaces. The limbs are then bent to secure their posterior position against the adjoining ribs. Stainless steel sutures are inserted between the limbs (as shown in the illustration), encircling the DSS pairs and secured in typical fashion for sternotomy sutures and sternal closure.

7) Warnings

• Do not use DSS devices that appear damaged or broken.
• Do not use the DSS if the package appears damaged or open.
• The DSS must be used in pairs. Do not use one DSS without a mate at the same intercostal/sternal level.
• The DSS is single use only and must never be used twice; do not reprocess or resterilize.
• As with the use of any other surgical device, use caution during implantation to prevent damage to surgical gloves.
• The Device for Sternal synthesis has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating or migration in the MR environment.

8) Potential Adverse Effects

• As with any foreign body, the DSS may cause an inflammatory reaction.
• The DSS can theoretically cause osteolysis of the bone in contact with the device.
• Wound dehiscence is a known complication of sternotomy procedures. None of these effects has been reported with the DSS.