Pillar System for the Pillar Procedure
The Pillar® System (“System”) consists of a delivery tool and an Implant. The delivery tool comes preloaded with the implant. The implant is a braided segment of polyester filaments intended for permanent implantation. The implant is approximately 18mm in length and has an approximate outer diameter of 2 mm. The delivery tool consists of a handle and 14- gauge needle. The needle is inserted into the soft palate; the implant is deployed by advancing the slider; and the delivery tool is removed. The delivery tool is disposable.
The System is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals, and for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).
Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction caused by the soft palate. The System is labeled for use by physicians and dental professionals with adequate training including maxillofacial surgeons
The System should not be used in the treatment of patients:
- Whose soft palate length, as measured from the hard palate junction to the base of the uvula, is <25mm.
- Under the age of 18.
Do not use substances that are incompatible with any of the product’s components (see Device Description section).
- Single use only. Do not resterilize.
- Sterile conditions should be maintained at all times while handling the System.
- Open or damaged product should not be used due to potential non-sterile conditions.
- Implant should not be removed from needle and/or modified prior to use.
- Delivery tool handle and needle should not be modified prior to use.
- Do not use excessive force during needle insertion, implant deployment, or delivery tool removal.
- If the implant is ejected from the needle prior to placement, discard the implant and delivery tool.
- After use, all components should be treated as biologically hazardous waste during disposal.
- Product that is damaged, or where the sterility has been compromised should be returned - Contact Medtronic for detailed instructions.
- Should the implant require removal or the patient request removal, a minimally invasive surgical procedure is required.
- The insertion of the implant should only be undertaken by those physicians who have a comprehensive knowledge of the indications, techniques and risks of the procedure.
- Avoid inserting into the uvula or too far laterally as the palate is usually thinner in this area and subsequent partial/full extrusion of the Implants may occur.
- Attempting to place the Implant into a pathway that has a breach on the nasopharyngeal aspect of the palate may result in extrusion of the Implant.
- If the Implant is visible, it has been placed too superficially and must be removed and replaced with a new Implant. Implants placed too superficially may result in partial or full extrusions. DO NOT reposition the needle in the original penetration site.
Use of the System involves potential risks normally associated with the use of any implanted device, including but not limited to, those listed below:
- Difficulty swallowing
- Erosion of implant
- Gastro-intestinal obstruction
- Implant aspiration
- Implant rejection
- Implant migration
- Mucosal edema
- Partial/full extrusion of Implant*
- Sore or scratchy throat
- Voice/taste change
- Allergic reaction to implant material
- Foreign body sensation
*Partial extrusions of the implant did occur during clinical studies, and patients should be informed of this potential complication.
- The use of additional implants for the treatment of mild-to-moderate obstructive sleep apnea (OSA) has not been studied and is currently not cleared for use by the FDA.
- If the implant is exposed at any time prior to needle insertion, discard the device.
- Ensure that the slider is not advanced during needle insertion in order to avoid premature exposure of the implant.
- Ensure that the needle does not exit any portion of the soft palate and become exposed. If the needle tip pierces the back of the soft palate, remove the needle from the tissue and determine a different insertion point. DO NOT reposition the needle in the original penetration site.