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NOVAPAK™

Postoperative Nasal Sinus Packing and Stent

Novapak™ is a single use, dissolvable nasal packing and stent for use following sinus surgery. It’s been designed to control bleeding and prevent adhesions while providing antibacterial effectiveness in a moist wound healing environment.1-4

Harmony transcatheter pulmonary valve (TPV) on decorative blue and white background

  

Beyond
Structural Stability

Discover how the Novapak™ Nasal Sinus Packing and Stent optimizes wound healing after functional endoscopic sinus surgery (FESS).

  

The right post-op sinus packing for your patient

Novapak™ Nasal Sinus Packing and Stent is designed to deliver meaningful therapeutic benefits and antibacterial effectiveness to support postoperative healing.1-4

Key features of Novapak™1-8

  • Supports vital tissue structures and stabilization at 48 hours
  • Dissolves within the nasal cavity with daily irrigation and natural mucus flow
  • Absorbs up to 32 times its weight in draining and bleeding of debrided mucosal surfaces
  • Acts as a hemostatic aid by absorbing and aggregating blood
  • Residence time is typically 7-14 days with adequate irrigation
  • Separates and maintains tissue and maintain moisture
  • Aids in the prevention of adhesions
  • No temperature-controlled environment required for storage or shipping
Novapak sponge image

  

How Novapak™ works1-4

The Novapak™ sponge is placed in the middle meatus of the nasal cavity and physically separates the mucosal tissue surfaces as a stent and, in turn, aids in preventing adhesion formation. Upon application, Novapak™ acts as a hemostatic aid by minimizing bleeding and oozing of the debrided mucosal surfaces via a tamponade effect, blood absorption, and stimulation of platelet aggregation.

Novapak™ hydrates with sterile saline and forms a gel. The packing dissolves within the nasal cavity with daily irrigation and natural mucus flow over several days. Residence time is typically 7-14 days with adequate irrigation. Alternately, the packing may be removed through gentle aspiration at the discretion of the physician.


Progression over 48 hours

  

Product specifications

Easy-to-use solution with
two configurations

Novapak™ is pliable, compressible, springs back when hydrated, and easily manipulated during placement. One sponge can be used in a bilateral procedure by cutting or tearing. Offered in standard and firm configurations for optimal support, stability and density, enabling surgeons to tailor therapy.1,2

Close-up of the Novapak packing.

Novapak™ Standard Novapak ™ Firm

CFN Number

CS3600-10 (10pk)

CS3900-10 (10pk)

Sizes

8cm x 1.8cm x 1.3cm

8cm x 1.8cm x 1.3cm

Residence Time

7-14 days

7-14 days (Novapak™ Firm dissolves slower than Novapak™ Standard.  Therefore, it provides stenting capabilities for a longer period of time.)

Structural Support

Up to 48 hours

Up to 48 hours

Absorption Capacity

Up to 32 times its weight

Up to 32 times its weight

Material

Chitosan Hydrochloride and Cellulose

Chitosan Hydrochloride and Cellulose
(10% more ingredients)

Storage Temperature

At room temperature

At room temperature

What is chitosan?

Chitosan is a polymer produced from chitin, a component of the hard external shell of shellfish. Its hemostatic properties have been extensively studied in civilian and military clinical settings.1-4

Novapak is contraindicated in patients with known shellfish allergies.

  

Additional Information

Novapak Value Analysis Brochure

ENT Product Catalog

Medtronic offers more than 5,000 products and instruments for ENT specialists.

Contact Medtronic

800-874-5797

1

Rao SB and Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic potential. J Biomed Mater Res. 1997; 34:21-28.

2

Malette WG, Quigley H, Gaines RD, Johnson ND, Rainer G. Chitosan: a new hemostatic. Ann Thorac Surg. 1983; 36:55-58.

3

Chou TC, Fu E, Wu CJ, Yeh JH. Chitosan enhances platelet adhesion and aggregation. Biochem Biophys Res Commun. 2003; 302:480-483. 

4

Dutkiewicz JK. Superabsorbent materials from shellfish waste–a review. J Biomed Mater Res. 2002; 63:373-381.

5

Costain, D.J., Kennedy, R., Ciona, C.J., McAlister, V.C., & Lee, T.D. (1997). Prevention of postsurgical adhesions with N,O-carboxymethylchitosan: examination of the most efficacious preparation and the effect of N,O-carboxymethyl chitosan on postsurgical healing. Surgery, 121 3, 314-9.

6

Li L, Wang N, Jin X, et al. Biodegradable and injectable in situ cross-linking chitosan-hyaluronic acid-based hydrogels for postoperative adhesion prevention. Biomaterials. 2014; 35:3903-3917.

7

Kourelis K and Shikani AH. Effectiveness of chitosan-based packing in 35 patients with recalcitrant epistaxis in the context of coagulopathy. Clin Otolaryngol. 2012; 37(4):309-313.

8

Shikani AH, Chahine KA, Alqudah MA. Endoscopically guided chitosan nasal packing for intractable epistaxis. Am J Rhinol Allergy. 2011; 25(1):61-63.

9

Internal Data Available.

10

FDA 510K, K202623.510K Summary Final

11

Athanasiadis, T., Beule, A., Robinson, B.H., Robinson, S.R., Shi, Z., & Wormald, P.J. “Effects of a novel chitosan gel on mucosal wound healing following endoscopic sinus surgery in a sheep model of chronic rhinosinusitis”. The Laryngoscope, 2008 Jun; 118 (6): 1088-94.

12

Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. “The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery”. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5.