Warnings, Indications, Precautions, Contraindications and Adverse Events

SEPTALIGN

Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. U.S. Federal Law restricts this device to use by or on the order of a physician.

INDICATIONS FOR USE

SeptAlign is used to support and straighten deviations in septal cartilage when suGicient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

CONTRAINDICATIONS

  • Presence of an active infection at the implantation site.

  • Patients known or suspected to have an allergy to polydioxanone or other bioabsorbable materials.

  • Use of the SeptAlign as a bridge or scaGold for multiple pieces of cartilage.

POTENTIAL ADVERSE EVENTS

Potential adverse reactions are those typically associated with surgically implanted materials, including:

  • Chronic inflammatory foreign body reaction

  • Infection potentiation

  • Septal perforation

  • Extrusion

Excessive activity, trauma, or load bearing may lead to bending, fracture, loosening, or migration of the Implant.

WARNINGS & PRECAUTIONS

  • For the safe and eGective use of this device the surgeon should be familiar with appropriate surgical procedures for its application. Improper patient selection, device selection, placement, positioning or fixation may result in undesired eGects. The device has not been evaluated to alleviate curvature which is associated with other structure pathology such as elongated cartilage, cartilaginous tilt, deviated maxillary crest and/or vomer and other structural abnormalities.

  • Absorbable devices provide temporary reinforcement and are not intended to replace normal healthy bone or cartilage.

  • Do not use in applications requiring permanent reinforcement.

  • Do not use the device if the integrity of the sterile packaging has been compromised or a loss of sterility is suspected.

  • Do not implant more than one device per procedure. Do not reuse.

  • Do not use in patients with allergy to polydioxanone.

  • Do not use in contaminated or infected areas as this might lead to potentiation of infection. Subsequent

  • infection may require removal of the device.

  • Do not expose the device to high temperatures such as those generated by electro-surgical instruments.

  • Excessive force should not be applied when pulling the needle and proximal anchor portion of the Implant through the septal cartilage. The force to pull the anchors of the Implant through cartilage may exceed those of pulling a standard suture through cartilage for conventional tissue approximation; great care and continuous evaluation of the integrity of the cartilage during insertion should be maintained.

  • Do not grip needle at the crimp with the implant. Do not reshape needles as this may result in breakage and loss of metal fragments.

TURBALIGN

Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. U.S. Federal Law restricts this device to use by or on the order of a physician.

INDICATIONS FOR USE

TurbAlign is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

CONTRAINDICATIONS

  • Do not place TurbAlign where the implant insertion path is obstructed or may otherwise encounter an unintended object.

  • Do not place TurbAlign in unstable nasal tissue. Unstable nasal tissue is defined as mucosal tissue in the nasal cavity that is not attached to underlying bone or cartilage and/or nasal tissue that may have tears, perforations or deep lacerations. The tissue condition at the planned site of insertion for TurbAlign should be assessed by the surgeon to determine if the tissue is suGiciently stable.

  • Patients known or suspected to have an allergy to polydioxanone or other bioabsorbable materials.

POTENTIAL ADVERSE EVENTS

Possible adverse eGects include but are not limited to:

  • Wound complications including hematoma, site drainage, infection, toxic shock syndrome and other complications that are possible with any surgery

  • Inflammatory foreign body reaction, foreign body sensation, pain or discomfort, infection, and extrusion

WARNINGS & PRECAUTIONS

  • As with any surgical procedure, care should be exercised in treating individuals with pre-existing conditions that may aGect the success of the surgical procedure such as highly inflamed or friable turbinates where tissue strength has been compromised.

  • Excessive force should not be applied when pulling the needle and Implant through the turbinate and septum; doing so may cause turbinate avulsion or other damage to tissues. The force to pull the anchors of the Implant through cartilage may exceed that of pulling a standard suture through similar tissues as during conventional tissue approximation; great care and continuous evaluation of the integrity of the turbinate tissue during insertion and pull-through should be maintained. Use of a Freer or other blunt instrument to medialize the turbinate toward the nasal septum will reduce the risk of damage to the tissues.

  • In the event post-operative packing is used, it should be carefully placed and removed in order to prevent accidental displacement of TurbAlign.

  • Do not reuse.

  • Do not expose the device to high temperatures such as those generated by electro-surgical instruments.

  • Do not grip needle at the crimp

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WEB-001-11