Replace Fixation With Fusion

InteliFUSE™ makes existing procedures and products obsolete.

The company’s patented StimuLINK™, a “smart“ shape memory mini-implant, replaces rods, nails, screws and wires and has gained FDA clearances for myriad orthopedic indications. The StimuLINK™, when implanted, changes shape to compress the fracture until removed, thereby promoting osteogenesis and fusion of the bone fragments. A smaller incision, reduced procedure and healing times are other benefits.

Technology

SHAPE MEMORY ALLOYS were discovered and developed in 1962 by scientists at the U.S. Naval Ordnance Research Laboratories. They found that alloys of nickel-titanium (nitinol) can assume one shape when cooled and another when warmed. Alloys having a double-memory exhibit a reversible effect, with heat causing a reaction reversed by cooling. First employed by the Navy, then in aerospace applications by NASA and more widely by aircraft manufacturers, shape memory alloys have now migrated to medicine.

FIXATION USING SMART ELEMENTS. While metallic staples have long been used for static fixation, the discovery of shape memory alloys and their ability--through the InteliFUSE patented StimuLINK™ designs--to apply continuous dynamic compression, is a major factor in bone uniting that speeds the healing process to repair, fuse and remodel fractures and deformities.

Further, StimuLINK™ implants are smaller and less bulky than other fixation devices, such as plates, screws and nails. They permit smaller incisions, which mean less trauma and scarring and faster post-operative recovery. And, because fewer holes need to be drilled and no screws are needed, quicker procedures are possible. Finally, these dynamic implants cost half the price of comparable static fixation devices.

The InteliFUSE™ system includes: the StimuLINK™, a shape memory alloy implant, which is available in designs, sizes and gauges appropriate to fixation of small to large bones; the InteliFUSER™, a thermal device controlled to non-necrotic temperatures, which contacts the StimuLINK™ after insertion to warm it, recovering the implant’s predetermined shape so that it may apply dynamic compression; and an instrument kit containing drill guides, drill bits, implant impactor, and accessories for precisely locating drill holes and inserting the implant.

Indications

FDA Clearances to Date:

CRANIOMAXILLOFACIAL
  • Maxillofacial & Mandibulofacial
  • Fractures & Osteotomies
  • Unloaded Craniofacial Fractures & Craniostomies

SOFT TISSUE
  • Fixation of Soft Tissue to Bone

HAND & FOOT
  • Bone Fragment & Osteotomy
  • Joint Arthrodesis

SMALL BONE FRAGMENT ADJUNCTIVE FIXATION
  • Clavicle, Ribs, Pelvis, Scapula, Sternum

UPPER LIMB SMALL BONE FRAGMENT ADJUNCTIVE FIXATION
  • Humerus, Ulna, Radius

LOWER LIMBS
  • Proximal Tibial Metaphysis Osteotomy
  • Small Bone Fragment Adjunctive Fixation in Femur, Fibula & Tibia






StimuLINK™ Implants

StimuLINK™ Shape Memory Implants are available in sizes, gauges and designs appropriate to fixation and fusion of small to large bones. Compression forces range from 7 to 13 lbs.

StimuLINK™ implants arrive ready-to-use from a sterile environment, sealed in blister packaging, clearly labeled and sterilized with Gamma rays to meet the exacting standards of Class IIb surgical implants.

Cordless Thermo-Activator

Electrodes activate implant compression at non-necrotic temperatures. It takes only seconds to warm the StimuLINK.

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