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
Overview
Beyond Structural Stability
DIscover how the Novapak™ Nasal Sinus Packing and Stent optimizes wound healing after functional endoscopic sinus surgery (FESS).
Product Details
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
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.
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
| 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 |
|
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
ENT PRODUCT CATALOG
Medtronic offers more than 5,000 products and instruments for ENT specialists.
BROWSE CATALOG
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.