Bioresorbable Nasal Packing Products

MeroGel Injectable Bioresorbable Nasal Packing and Sinus Stent

Indications

MeroGel^® Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.

Contraindications

MeroGel Injectable is contraindicated in patients with a known hypersensitivity to hyaluronan or its derivatives.

Warnings and Precautions

In rare instances, the physiochemical condition associated with sinus surgery, both with and without sinus packing, may present a risk of toxic shock syndrome (T55). Warning signs of TSS include: sudden fever, vomiting, diarrhea, dizziness, fainting (or near fainting when standing up). and/or a rash that looks like a sunburn. MeraGel Injectable exhibits no antimicrobial properties; it is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections.

Do not inject intravascularly.

Foreign body reaction may occur as with most surgical adjuvant treatments. MeroGel Injectable must be used according to the instructions for use. Read instructions prior to use.

MeroPack Bioresorbable Nasal Packing and Sinus Stent

Indications

MeroPack^® Bioresorbable Nasal Dressing and Sinus Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to help prevent lateralization of the middle turbinate during the postoperative period.

Contraindications

MeroPack is contraindicated in patients with known hypersensitivity to formaldehyde, hyaluronan, bovine collagen or their derivatives.

Warnings and Precautions

• In rare instances the physiochemical condition associated with nasal surgery, both with and without nasal packings, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up) and /or a rash that looks like a sunburn. MeroPack Bioresorbable Nasal Dressing and Sinus Stents exhibit no antimicrobial properties; they are not bacteriostatic toward pre-existing infections; nor do they prevent the occurrence of new infections. In the case of pre-existing infections it is recommended that appropriate treatment be instituted.
• It is recommended that MeroPack be used immediately after opening of the pouch; discard any unused portion of the device.
• Foreign body reaction may occur as with most surgical adjuvant treatments.
• MeroPack must be used according to the instruction for use. Read instructions prior to use.
• MeroPack must be thoroughly hydrated with sterile saline when placed in the nasal cavity to ensure proper resorption in under 14 days. Inadequate hydration can lengthen absorption time.
• Inspect the packaging to be sure that it is intact and undamaged prior to use. Do not use the product if the pouch is opened or damaged. Do not reuse.

NovaShield Injectable Nasal Packing and Stent

Indications for Use

The NovaShield™ material is intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing to:

• Separate tissue or structures compromised by surgical trauma.
• Separate and prevent adhesions between mucosal surfaces in the nasal cavity.
• Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation.
• Act as an adjunct to aid in the natural healing process.

NovaShield is indicated for use as a nasal packing to treat epistaxis.

Contraindications

Patients with known shellfish allergies.

Warnings

W1. NovaShield contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish.

• Physicians should test for shellfish allergic response if status unknown, prior to use.

W2. In rare instances, the physiochemical condition associated with Functional Endoscopic Sinus Surgery (FESS), both with and without material application, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up), and/or a rash that looks like a sunburn.

W3. Foreign body reaction may occur as with most surgical adjuvant treatments.

W4. NovaShield must be used according to the instructions for use. Read instructions prior to use.

W5. Do not add pharmaceuticals to this product.

Precautions

P1. Verify that the surgical field is not bleeding excessively. Control excessive bleeding, as you would normally, prior to application of the NovaShield material.

P2. Inspect the packaging to be sure that it is intact and undamaged prior to use. Do not use the product if the packaging is opened or damaged.

P3. Do not reuse or resterilize NovaShield.

• View the indications, safety, and warnings for the Integrated Power Console (IPC^® System).
• View the indications, safety, and warnings for the Straightshot^® M4 Microdebride

• View the indications, safety, and warnings for the Hydrodebrider^® Powered Endoscopic Irrigation System.

• View the indications, safety, and warnings for Endo-Scrub^® 2 Lens Cleaning Sheaths.