Pioneer Sternal Cable System
Cardiothoracic: Cable System
The Cable System is an improved alternative over monofilament wires traditionally used to close median sternotomies. Multi-strand stainless steel or titanium cable is tensioned and secured using the unique Tensioner/Crimper instrument. The cable is smooth and flexible, making insertion and removal easy and intuitive. The Tensioner assures adequate and equal tension is applied before crimping. Multiple “figure-8” constructs work as one unit to provide optimal stabilization in all planes of motion.
The Pioneer Sternal Cable is approximately ten times stronger in fatigue strength than the standard sternal wire.*
The tensioning system permits adjustment of the cable intra-operatively to a known value, allowing for consistency in pressure along the midline.
The sternal cable uniformly hugs the bone in a “figure 8” construct, thus decreasing the possibility of loosening, micro-motion, potential post-operative implant failure and related patient risk.
The strength of the sternal cable and its method of attachment, coupled with the ability to achieve consistency in tension, make this a system trusted by many surgeons. It has been implanted in over 200,000 patients!
*Data on file at Pioneer Surgical.
- Diameter: 1.1mm SS, 1.3mm Ti
- Low profile crimp reduces tissue irritation
- The unique multi-strand design of the cable reduces the risk of kinking
Indications and Warnings
Pioneer cable products were designed as a replacement for monofilament wire and may be used anywhere monofilament wire has previously been indicated. All implants are single use and implanted system components should never be reused under any circumstances. An explanted device should never be re-implanted. If reused, single use devices may not perform as intended and could cause serious injury. Sternal Indications: Cardiovascular sternal closure. General Indications: Temporary implant to stabilize/secure bone fractures; Augment the process of bony fusions; trauma or reconstructive surgery.
WARNINGS AND PRECAUTIONS
Do not intermix implants with different metallic alloy types; Do not use if packaging is damaged/opened prior to use; Operating surgeon should have a good understanding of the cable system, surgical technique, and bio-mechanical principles of cable fixation; Federal law (USA) restricts the use of this device on the order of a physician only; Avoid over tensioning cables as they may break/fray; Cables may cut through soft bone that is not protected and immobilized.
Contraindications may include, but are not limited to: Presence of documented infection; Patient metal allergy or intolerance; Presence of severe osteopenia and/or osteoporosis, rapid bone absorption, metabolic bone disease, cancer, tumor, or tumor like condition of the bone; Inadequate tissue coverage of implant site; Interference with other critical anatomical structures; Undiagnosed infection, end stage malignant disease, or other unexplained disease; Severely comminuted fractures; Any patient unwilling to follow postoperative instructions; Any situation not defined by Indications.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.