This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the implant's material and surgical aspects and instructed as to its mechanical and material applications and limitations.
The Catalyft™ PL Expandable Interbody System is an expandable titanium alloy interbody device consisting of interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. Device lifetime for the Catalyft™ PL Expandable Interbody System is one year in which the device is expected to achieve its performance (e.g. immobilization and stabilization as an adjunct to fusion) and maintain its safety until fusion occurs. After fusion, the device is further designed and tested to survive the life of the patient. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with patients diagnose with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems.
The Catalyft™ PL Expandable Interbody System is not intended for cervical or thoracic spine use. Contraindications include:
Nota bene: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
Take into consideration that the segmental stability can be affected by a variety of factors.
Adverse effects may occur when the device is used either with or without associated instrumentation. The risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include:
Note: additional surgery might become necessary to correct adverse effects.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise results. Use of this product without autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or in cases that do not develop a union will not be successful.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and placement of implants are important considerations in the successful use of the system. Further, proper selection and compliance of the patient will greatly affect results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/ drug abuse patients and those with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery.
Document the used implants per patient with REF and LOT, so tracking, which is required by law, is guaranteed. Implants are only for single use. Do not re-process or re-use devices labeled as single use devices. Re-processing or re-use of single use devices may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information in this document should be conveyed to the patient.
For US audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the human anatomy. Unless great care is taken in patient selection, placement of implant, and postoperative management to minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the device before the fusion process is complete, which may result in further injury or the need to remove the device prematurely.
Installation and positional adjustment of implants must only be accomplished with special ancillary instruments and equipment supplied and designated by Medtronic. In the interests of patient safety, do not use Medtronic implants with devices from any other source.
Never, under any circumstances, reuse a Catalyft™ PL Expandable Interbody System implant. Even when a removed implant appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage.
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.
Visually inspect all sterile-barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not use the product. Contact Medtronic for return information.
Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return information.
Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package is broken, the product should not be re-sterilized. If a loaner set is used, all sets and components should be carefully checked for completeness and to ensure there is no damage prior to use.
The Catalyft™ PL Expandable Interbody System was determined to be MR-Conditional based on non-clinical testing and engineering rationales. A patient with this device can be safely scanned immediately after device placement under the following conditions:
Under the scan conditions defined, a worst-case interbody fusion device representative of the Catalyft™ PL Expandable Interbody System produced a maximum temperature rise of <5.0°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by a worst-case interbody fusion device representative of the Catalyft™ PL Expandable Interbody System extends approximately 13mm for a spin echo sequence and 23mm for a gradient echo sequence in a 3-Tesla MR system. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
If the Catalyft™ PL Expandable Interbody System is used in connection with any device which is not MR Conditional, be advised this combination was not tested in the MR environment and, therefore, higher heating and possible injury to the patient may occur. The presence of other implants or the health state of the patient may require modification of MR conditions.
To report any product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the competent authority of the Member State in which they are established.
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is required, contact Medtronic.
After the EUDAMED website is launched, the Summary of Safety and Clinical Performance (SSCP) can be found at https://ec.europa.eu/tools/eudamed