COMPARISON_XomedMeroPack and Invotec Final Nasal Dressing ...

Memorandum
Date: 3/4/2010
To: Invotec US Sales Force CC: Jeff Aull
From: Ken Pawlowski
Re: Comparison: Meropack to Final Nasal Dressing
I understand there may be some customer misunderstanding of the clinical differences between Invotec’s Final
Nasal dressing and pack and Medtronic Xomed’s Meropack nasal dressing and sinus stent. Below, is a
comparison of the two materials based upon claims taken directly from each supplier’s printed literature.
Also, attached is an abstract from a clinical study published in 2008 discussing the efficacy of Meropack as nasal
dressing and pack in endoscopic sinus procedures.
Published Claim
Design Criteria
Material
Claims Comparison from printed supplier literature
MeroPack Bioresorbable Nasal
Dressing and Sinus Stent
To address hemostatic and woundhealing
needs of the sinus surgeon
Sponge: 80% esterified hyaluronic acid
and 20% collagen sponge
Invotec International, Inc.
6833 Phillips Industrial Blvd ● Jacksonville, Fl 32256-3029
Ph 904-880-1229 ● Fax 904-886-9517 ● www.Invotec.net
Invotec Final ENT Sponge
To address the hemostatic, stenting an
buttressing and wound healing needs of the
ENT Surgeon
Sponge: 100% purified porcine collagen
sponge structurally formulated specifically
for ENT procedures
Insertion, Dry In its dry state, it is easily inserted In a dry state, is easily inserted, packed and
manipulated.
Insertion ,Wetted Upon hydration, swells to 10mm, in 6
seconds, transforms to a muco-adhesive
gel.
Upon hydration swells from 4mm to ~ 6-
8mm , preventing possibly of tampanode
damage to delicate tissue, into an
amorphous spongy gel, which maintains it
structural integrity while being manipulated;
is easily packed into specific spaces.
Does not fragment when handled, while wet.
Absorption Ability Absorbs 14 times its weight in fluid Absorbs 45-50 times its weight in fluid

Published Claim
Stenting Characteristics
Hemostatic Ability
MeroPack Bioresorbable Nasal Dressing
and Sinus Stent
Provides excellent stenting capabilities to prevent
adhesions between mucosal surfaces during
mesothelial cell regeneration and lateralization
of the middle turbinate 1
(note footnote, below and clinical report attached)
Collagen is added (20% content) to help
control minimal bleeding following surgery or
nasal trauma. In contact with bleeding
surfaces, it attracts platelets to facilitate
aggregation.
Wound Healing Moist Wound Environment
Residence Time
Pharmaceutical
Friendly
In the hydrated state, it transforms into a
biocompatible, muco-adhesion gel to provide a
moist wound-healing environment to aid in the
healing process.
Meropack is slowly resorbed (breaks down, not
absorbs) within two weeks, eliminating the
need for painful packing removal. If desired, it
is easily removed by suctioning at the first
postoperative visit.
March 4, 2010
Invotec Final ENT Sponge
FDA Cleared, specifically, for adhesion
prevention in the post op sinus cavity.
Composed of 100% collagen, and with
a structure of leaflet lamella and minimal
micro pore count, hemostasis, in
recurrent nose bleeding with
hypertension, to extensive
nose/throat Fibrom, is quickly
achieved, even in the presence of
blood thinners (Aspirin or Clopidogrel,
Plavix®); Hemostasis occurs in ~ 1-2
minutes. 2
Note: This material has been
successfully used as a hemostatic
sponge for 60 years.
Contributes directly to accerated wound
healing
The amino acid composition of the
Alpha-Gelatine (Collagen) is
characterized by the high content of
Glycin (33%), Proline, 2-Leucine, 4-
Leucine; these are the main activators
of Bone and Wound healing. Alpha-
Gelatine is equivalent to accelerated
gentle wound healing 3
Liquifies in 3-5 days; absorbs
completely in 7-9 days.
Dry cavity, no residue.
No claim Highly pharmaceutical friendly
Price Estimated $60.00 per side $31.20 per side
Source: References available at www.Xomed.com and Invotec International, Inc, Jacksonville.
1
This claim has been refuted by Hu KH et al, Effects of Meropack in the middle meatus after functional endoscopic sinus surgery in children with chronic sinusitis,
International Journal of Pediatrics Ohorhinolaryngol, 2008 Oct;72 (10):1535-40. Epub 2008, Sug 26. Results: “Prevented postoperative hemorrhage, but did not
significantly reduce synechiae after endoscopic sinus surgery”
2
Suckfull M.; Report on experimental therapy with the hemostatic device X-Blod in the discipline of otorhinolaryngology , Department of ENT, Ludwig-Maximilaians-
Universitaet, Munich, Germany, January 2009.
3
QserveConsultaqncy BV, Amsterdam, The Effect of Gelatine on Wound Healing Gelita Medical B.V., Doc No.: 1105/09/ld; October, 2009
2