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The IntraSPINE® device is an interlaminar medical device designed for the interspinous space, featuring a laminar support. It consists of a dimethyl siloxane (silicone) wedge, available in various sizes to fit the intervertebral level, and a polyethylene terephthalate ligament. The wedge is covered with a woven polyethylene terephthalate fabric, with a protective sheeting on the anterior side in the medullary zone. The ligament's tension is applied using a titanium loop (TA6V).
The IntraSPINE® prosthesis is made of dimethyl siloxane, polyethylene terephthalate, and titanium. Ancillaries and trial prostheses are constructed from stainless steel, acetal copolymer, and dimethyl siloxane. The product is non-human and non-animal in origin, and non-resorbable.
The IntraSPINE® prosthesis acts as an elastic support device with a shock-absorbing effect. Its interlaminar implantation positions it close to the center of rotation, which facilitates the shock-absorbing action and restores tension to the disc-ligamentous structures due to the flexibility of the supraspinous wedge. The primary function of the ligament, which encircles the upper and lower vertebrae at the implantation level, is to assist the posterior ligament during flexion. The IntraSPINE® has been validated for long-term implantation in the human body.
The IntraSPINE® prosthesis is recommended for use in the lumbar spine and sacral region (L1 to S1) in cases of facet syndromes, foraminal stenosis, degenerative disc disease, and interspinal ligament insufficiency.
The device should not be implanted in cases of allergy to any of its components, in growing children, in infected areas, or in pregnant women. Factors that may compromise successful implantation include severe osteoporosis, significant spinal deformities, local bone tumors, systemic or metabolic disorders, infectious diseases, obesity, drug addiction, intense physical activity (e.g., competitive sports or strenuous labor), or surgery at more than two levels with an IntraSPINE® prosthesis.
Complications likely related to the device include prosthesis infection, device breakage (ligament rupture, fixed wing breakage, knitting tearing), needle dislodgement, device loosening, permanent elongation of the ligament, device migration, wedge displacement, spondylolisthesis at the dynamically stabilized segment, persistent or worsening pain attributed to the dynamically stabilized level requiring revision surgery with interbody fusion at that level, spinous process fractures (intraoperative, postoperative, or during device removal due to infection) potentially associated with implant dislocation, delayed reoperation due to lack of recovery, incorrect implantation, inappropriate positioning (posterior or wrong level), seroma/swelling around the device, inflammatory reactions, allergic reactions, and foreign body reactions. In some cases, the medical instrument had to be removed and pedicle screw fusion performed.
Complications less likely related to the device but associated with surgery or the patient's condition include pseudomeningocele, fistula, dural tear, persistent CSF leakage, meningitis, loss of neurological function, cauda equina syndrome, neuropathy, neurological deficits, arachnoiditis and/or muscle loss, nerve compression and/or pain, urinary retention or loss of bladder control or other types of urological system damage, fracture, bone loss or decrease in bone density, nucleus pulposus herniation, disc disruption or degeneration at, above, or below the surgical level (adjacent segment degeneration), non-union or pseudoarthrosis, delayed union, malunion, cessation of any potential growth of the operated portion of the spine, loss or increase in spinal mobility or function, hemorrhage, hematoma, edema, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, wound infection, damage to blood vessels or other types of cardiovascular system damage, and development of respiratory problems.
The implants are made of non-ferromagnetic materials and have a geometry that does not generate induced current. They are fixed to tissues, making mobilization unlikely. They are considered MRI compatible. Safety, particularly regarding heating and migration, has been evaluated through bibliographic data compared to devices with similar composition, shape, and use. This evaluation concluded conditional compatibility for MRI up to 1.5 Tesla. As a precautionary measure, MRI scans within 48 hours of implantation should be avoided, and the person in charge of the scan should be informed of the recent implantation if the examination is essential. Devices with high contrast to the biological environment may generate "artifacts" that must be considered for accurate execution and interpretation of imaging examinations.
Before use, verify the integrity of the prosthesis, trial prostheses, ancillaries, and packaging. Do not use if damaged or expired. Unpacking and manipulation must follow aseptic standards to ensure sterility. The surgeon must verify that the lot number, model, and size match the label of the inner pouch. Prevent contact with objects that may alter the surface. Operating conditions: temperature from +32°C to 42°C. Implants must resist biological fluids and body tissue discharge. The IntraSPINE® prosthesis, trial prostheses, and ancillaries must only be used by a qualified surgeon trained in spinal surgery and the IntraSPINE® surgical technique. The IntraSPINE® is made of soft materials; contact with harder materials may alter its mechanical behavior and lifetime, so avoid such contact. The prescription of the device is made by the surgeon. "Topping off" is not contraindicated but requires special attention. Use of COUSIN BIOTECH ancillaries and specific trial prostheses is required for implantation.
Implants must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature. Transportation should be in closed vehicles according to transport regulations. Important: Do not reuse and do not resterilize the IntraSPINE® prosthesis. It is designed for single use. Reuse or resterilization carries risks such as loss of sterility, infection, loss of effectiveness, and relapse. Ancillaries and trial prostheses are Class I and Class IIa medical devices, respectively, intended for temporary and reusable use. Unlike the IntraSPINE® prosthesis, ancillaries and trial prostheses (included with the instrument kit/set) are furnished unsterile. Before first use, ancillaries and trial prostheses must be cleaned appropriately and sterilized in an autoclave. Decontamination and cleaning of ancillaries are the responsibility of healthcare centers. The prescribed methods and materials must be used to reduce the risk of transmission of ATNC (French health ministry - DGS/R13/2011/449 dated 01/12/2011). This step must occur before the first use and immediately after use to prevent particle or dry secretion adhesion. Detachable instruments must be dismantled. Recommended cleaning products include a neutral enzymatic detergent or suitable cleaning products (neutral or mildly alkaline) for surgical instruments in compliance with regulations. Do not use corrosive or caustic cleaning products. Two cleaning processes are possible: automated cleaning in a washer-disinfector with manual pre-cleaning, and manual cleaning only. Both processes involve steps for contamination removal, pre-soak, ultrasonic cleaning (for automated), soaking, automated washing (for automated), final rinse, final drying, and tidying/storage. Manual cleaning involves disinfection application and manual disinfection steps. Sterilization of ancillaries is the responsibility of healthcare centers. The recommended method for sterilization is in an autoclave using specific containers (mesh basket, plastic tray, plastic tray in an autoclavable peel pouch). Sterilization in peel pouches without a container is not recommended as ancillaries may perforate the films. An autoclave sterilization protocol is provided with specific temperature and cycle times. After each cleaning/sterilization cycle, verify the integrity and proper functioning of surgical instruments. If ancillaries are not used immediately, store them after sterilization in a tray in a peel pouch. Ancillaries and trial prostheses must be stored in their dedicated container or equivalent packaging to prevent damage, in a dry place, away from sunlight, and at room temperature, in their original packaging. Explantation and disposal of devices must comply with ISO 12891-1:2015 "Surgical implants - Retrieval and analysis of surgical implants" Part 1: "Retrieval and handling." Any explanted device must be returned for analysis according to the current protocol. Explanted medical devices must be disposed of according to national standards for infectious waste. Disposal of non-implanted devices is not subject to specific recommendations.
General| Brand | Cousin Biotech |
|---|---|
| Model | INTRASPINE |
| Category | Medical Equipment |
| Language | English |
