Comprehensive Solutions for Head and Neck Reconstruction TRUMATCH® CMF Personalized Solutions Personalized implants based on a virtual surgical plan may result in OR time savings and optimal reconstruction results
Patient SpecificPlatefor Contouring – PSPC Plate, contoured based on unique patient anatomy and clinical need
Patient Specific Plate for Mandible – PSPM* The plate, milled from a titanium blank, has customizable design features and improved strength compared to MatrixMANDIBLE™ System standard plate2*
Titanium 3D Printed Plates Fully customizable patient specific plates and implants, 3D printed for the most complex situations such as “double barrel” mandible reconstructions and mandible graft containment
*Patient specific plate for mandible fatigue testing shows increased fatigue life of both 2.0 and 2.5 mm profiles in comparison with MatrixMANDIBLE 2.5 mm thick plates. Bench test results may not necessarily be indicative of clinical performance. 1. DePuy Synthes, Data on File, DJ8724. MatrixMANDIBLE Preformed Reconstruction Plates: A Comparison of Fatigue Life with the MatrixMANDIBLE Traditional Reconstruction Plates. 2. Bautista R. DePuy Synthes Dynamic Testing of Patient Specific Plates (PSP). 6/25/2013. Report MT12-261.3.
TRUMATCH® CMF Personalized Solutions for Midface Reconstruction ■
Fully personalized implant designs for complex midface reconstruction and for augmentation by means of an onlay design
Related Products ViviGen® and ViviGen Formable® Cellular Bone Matrix Osteogenic, osteoconductive, and osteoinductive allograft bone void filler3
Piezoelectric System Ultrasonic surgical system cuts mineralized bone; soft tissue sparing
3. Data on file at LifeNet Health DHF 12-008.
We offer comprehensive solutions for head and neck reconstruction. Manufactured or distributed by: Synthes Products USA, LLC 1302 Wrights Lane East West Chester, PA 19380
ViviGen® , ViviGen Formable® and PliaFX® are registered trademarks of LifeNet Health.
Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132
Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this brochure for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.
Note: For recognized manufacturer, refer to the product label. www.jnjmedicaldevices.com © DePuy Synthes 2019. All rights reserved. 106566-190130 DSUS 05/19 DV
Some devices listed in this sell sheet may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. All third-party trademarks used herein are the trademarks of their respective owners.
CAN-166152-210201
Patient Specific Plate for Mandible – PSPM
TRUMATCH® CMF Personalized Solutions for Mandible Reconstruction Titanium 3D Printed Plates
Comprehensive Solutions for Head and Neck Reconstruction
Patient Specific Plate for Contouring – PSPC
TRUMATCH® CMF Personalized Solutions for Midface Reconstruction
Harmonic®
Proven clinical and economic outcomes from the industry leader in head and neck
HARMONIC FOCUS® technology has been evaluated in more peer-reviewed clinical articles than LigaSure™ Small Jaw and LigaSure™ Exact combined2 HARMONIC® technology, the proven leader in advanced energy with more than 22 million procedures worldwide.3
Enables precise energy delivery, efficiency and superior clinical outcomes1 Speed
Hemostasis
Critical structures
Cost savings
Reduced total operative time by 31%4
Reduced intraoperative blood loss by 45ml4
Same nerve function following use at 2mm from sciatic nerve5
Reduced total operative costs by 10%6
31 %
(p<0.001)
45ml
(p<0.001)
No difference
10%
(p=0.007)
vs. conventional methods in thyroidectomy procedures 1 Based on a meta-analysis of HARMONIC FOCUS® (HF) versus clamp, cut and tie, where HF reduced OR time, intra-operative blood loss, length of stay and drainage volume (all p≤0.01). Cheng et al., A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques. Thyroid Research (2015) 8:15 2 As per a literature search conducted by Ethicon in Scopus between 01/01/2008 and 05/11/2016 3 Internal global sales data as of June 2016 4 Based on a meta-analysis of HARMONIC FOCUS® (HF) versus clamp, cut and tie, where HF reduced operative time (p<0.001) and intra-operative blood loss (p<0.001). Cheng et al., A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques. Thyroid Research (2015) 8:15. 5 In a preclinical rat model that compared cold scissors, HARMONIC ACE®+, HARMONIC FOCUS® and monopolar electrosurgery (MES). Incision with cold scissors, HARMONIC ACE®+ and HARMONIC FOCUS® at 2mm from the sciatic nerve were not different via compound action potential (1621, 1519, 1803 mV-ms), conduction velocity (61.8, 62.3, 60.3 mm/ms), depolarization time (229.5, 211.6, 248.1 micro secs), repolarization time (2687, 2435, 2650 micro secs), vForce (20.2 , 17.0, 19.1 g), dForce (24.0, 21.4, 27.7 g) and beta-APP (12.6, 18.1, 18.6 % incidence), respectively (p-value for all >0.05). At 2mm from the sciatic nerve, MES resulted in significantly slower conduction velocity (58.5 mm/ms), longer depolarization time (283.1 micro secs), longer repolarization time (4150 micro secs) and higher incidence of beta-APP infiltration (31.8 % incidence) than cold scissors (p-value for all <0.05). (Note: p-values are comparison to cold scissors) 6 Cheng H et al., Hospital costs associated with thyroidectomy performed with a Harmonic device compared to conventional techniques: a systematic review and meta-analysis. J Med Econ. 2016 Apr 5:1-9. [Epub ahead of print]
HARMONIC FOCUS®+ Shears
vs.
LigaSure™ Small Jaw and Exact
The delivery of energy is key The effects of “radiated” electrical energy when activated 2mm from a nerve
How HARMONIC® technology works
How ABP technology works Electrical energy passes from active electrode to a return electrode.
Hand piece converts electrical energy to mechanical energy.
Compared to Ligasure™ Small Jaw, in a preclinical rat model HARMONIC FOCUS®+ Shears exhibited:
Mechanical energy heats, cuts and seals tissue via friction.
Electricity is driven into the tissue and generates heat inside the tissue.
• 57% less nerve inflammation1 • 50% less nerve damage2 The heat generated in the tissue extends to the device, making the tissue hotter than the device.
The heat starts in the blade and extends into the tissue, making the blade hotter than the tissue.
“Radiated” electrical energy
Designed for head and neck surgery HARMONIC FOCUS®+ Shears were designed with a small profile to provide precise dissection and delivery of energy in tight spaces
HARMONIC FOCUS®+ Shears vs. LigaSure™ Exact HARMONIC FOCUS®+
LigaSure™ Exact
Active blade width
Clamp arm width
Jaw height
Jaw aperture
37% narrower3
10% thinner4
22% smaller5
98% greater6
active blade at the distal tip
clamp arm at the distal tip
jaw height at the distal tip
jaw aperture
The power of Adaptive Tissue Technology’s thermal management Adaptive Tissue Technology enables more precise energy delivery and improved temperature management7
HARMONIC FOCUS®+
LigaSure™ Exact
Comparison of the 20th consecutive transection on porcine jejunum.
20.0°C
No significant difference in clamp arm temperature between HARMONIC FOCUS®+ and LigaSure™ Exact.8
200.0°C
For more information, contact your local Ethicon sales professional or go to www.ethicon.com 1 As exhibited in a preclinical rat model when activating 2mm away from the sciatic nerve. Inflammatory cell presence measured via H&E staining - 9.2% (HAR9F) vs. 21.4% (SJ), p=0.005 2 As exhibited in a preclinical rat model when activating 2mm away from the sciatic nerve. Mean nerve damage assessed as axonal transport impairment: 12.2% (HAR9F) vs. 24.3% (SJ), p<0.001 3 Metrology study comparing the width of the distal end of the active blade for HARMONIC FOCUS®+ vs LigaSure™ Exact (1.37mm vs 2.19mm). 4 Metrology study comparing the width of the clamp arm at the distal end for HARMONIC FOCUS®+ and LigaSure™ Exact (1.98mm vs 2.19mm). 5 Metrology study comparing distal jaw height of HARMONIC FOCUS®+ vs LigaSure™ Exact (2.82mm vs 3.62mm). 6 Metrology study comparing the jaw aperture of HARMONIC FOCUS®+ vs LigaSure™ Exact (23.4mm vs 11.8mm). 7 vs. HARMONIC ACE® without Adaptive Tissue Technology 8 Benchtop thermal testing comparing HARMONIC FOCUS®+ and LigaSure™ Exact. No statistically significant difference existed (95% confidence interval for difference in median clamp arm temperature: -5.0 to 1.0 C°).
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. The third-party trademarks used herein are trademarks of their respective owners. ©2019 Ethicon, Inc. All rights reserved. 108058-190221
choose a different path
Nasal polyp reduction following the SINUVA Way
What if you could give your nasal polyp patients an alternative path instead of repeat ethmoid sinus surgery? Prepare your sinus surgery patients for the path ahead if their nasal polyps recur While sinus surgery may help relieve symptoms, nasal polyp recurrence is common and patients require medical management postoperatively.1,2 Nasal polyps have been shown to recur in 35% of patients at 6 months and 40% of patients at 18 months after sinus surgery.2
Discuss nasal polyp recurrence with your patients and ensure they schedule postoperative in-office visits to monitor nasal polyp recurrence. Follow the SINUVA Way for your patients with recurring nasal polyps SINUVA treats nasal polyps with targeted delivery of mometasone furoate for up to 90 days3 PROVEN EVEN AFTER 1 ESS In RESOLVE II,* 41.3% (n=83) of patients treated with SINUVA had 1 prior ESS4 NO SURGERY In-office procedure with local anesthesia3
LOCALIZED DRUG DELIVERY Reliance on patient compliance is minimized3 NO ROUTINE DOSING SINUVA does not have to be taken daily, weekly, or monthly, and is removed at Day 90 or earlier3
ESS, endoscopic sinus surgery. *Please refer to the back page for RESOLVE II study design.
Keep track of your patients by electronically submitting enrollment forms and managing information in the SINUVA Provider Portal.
Explore the SINUVA Way at SINUVA.com/hcp INDICATION SINUVA Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Patients with a known hypersensitivity to mometasone furoate or any of the ingredients in SINUVA should not use SINUVA. Please see additional Important Safety Information on the next page.
SINUVA delivers sustained symptom relief up to Day 903,4 RESOLVE II (n=300)3,4
Co-primary outcomes3-5
Secondary endpoints4
Nasal obstruction/congestion score*† • Mean change in score (SD) for SINUVA vs mometasone furoate (MF) nasal spray alone: Day 30: –0.80 (0.73) vs –0.56 (0.62) (P=0.0074) Day 90: –0.93 (0.80) vs –0.69 (0.79) (P=0.0248) • 30% relative improvement at Day 30 compared to once daily MF nasal spray alone
Reduced eligibility for repeat surgery† • Only 39% of patients were still indicated for repeat sinus surgery at Day 90 after treatment with SINUVA vs 63% of patients in the control group (P=0.0004)
Bilateral polyp grade* • Mean change (SD) for SINUVA –0.56 (1.06) vs –0.15 (0.91) with MF nasal spray alone (P=0.0073) • 74% relative improvement in bilateral polyp grade from baseline to Day 90 compared to once daily MF nasal spray alone
Improves diminished sense of smell† • Significant improvement in their self-reported sense of smell score at Day 90 on a six-point Likert scale • Mean change (SD) for SINUVA –1.20 (1.66) vs –0.76 (1.60) with control (P=0.0470)
SD, standard deviation. Study Design: The RESOLVE II study was a randomized, controlled, double-blind, multicenter study with 300 patients. Patients were ≥ 18 years of age with chronic sinusitis who had prior bilateral total ethmoidectomy, but were indicated for revision endoscopic surgery because they presented with moderate to severe nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to sinonasal polyposis despite the use of intranasal corticosteroid sprays and recent high dose steroids. 201 patients were randomized to the SINUVA treatment arm where they underwent bilateral placement of SINUVA in the ethmoid sinuses. 99 patients were randomized to the control arm where they received a sham procedure. Patients in both study arms received once daily mometasone furoate nasal spray (200 μg) through Day 90.3,4 * Co-primary endpoints: Change from baseline to Day 90 in bilateral polyp grade, as determined by an independent panel on a scale of 0 (no visible nasal polyps) to 4 (nasal polyps completely obstructing nasal cavity). Change from baseline to Day 30 in nasal obstruction/congestion score, as determined by patients on a scale of 0 (no symptoms) to 3 (severe symptoms).3 Secondary endpoints: Change from baseline to Day 90 in nasal obstruction/congestion score, as determined by patients on a scale of 0 (no symptoms) to 3 (severe symptoms). Proportion of patients still indicated for repeat ESS at Day 90 despite ongoing intranasal steroid use based on clinical investigator assessment using study-specific criteria. Decreased sense of smell and facial pain/pressure score change from baseline to Day 90, as determined by patients on a six-point Likert scale of 0 (absent) to 5 (very severe). Secondary endpoints were prespecified and adjusted for multiplicity.4
†
IMPORTANT SAFETY INFORMATION (continued) WARNINGS AND PRECAUTIONS Local Effects: Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma. Ocular Effects: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. Immunosuppression: Patients taking corticosteroids are more susceptible to a more serious or even fatal course of chickenpox or measles than healthy individuals. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
Hypercorticism and Adrenal Suppression: If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. There are no studies evaluating repeat implantation of the SINUVA Sinus Implant. ADVERSE REACTIONS The most common adverse reactions observed (> 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis. POSTMARKETING EXPERIENCE The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, epistaxis. Rx only. Please see accompanying Full Prescribing Information for SINUVA, also available at SINUVA.com/PI.
References: 1. Sedaghat AR. Chronic rhinosinusitis. Am Fam Physician. 2017;96(8):500-506. 2. DeConde AS, Mace JC, Levy JM, et al. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555. 3. SINUVA [Prescribing Information]. Menlo Park, CA: Intersect ENT; 2020. 4. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018;8(4):471-481. 5. Data on file, Intersect ENT, Inc. CR-00014; Supplemental Statistical Analyses Rev 1.0 January 17, 2018.
For more information, visit SINUVA.com/hcp Intersect ENT and SINUVA are registered trademarks of Intersect ENT, Inc. in the United States and other countries. ©2021 Intersect ENT, Inc. All rights reserved. MPM-12096 Rev. 1.0
TELE PACK + COMPACT ENDOSCOPY FOR ENT
Enabling Anywhere Care – The All-in-One Diagnostic and Procedural Platform for Endoscopy The TELE PACK + can help you achieve your “quadruple aim” focus through: •A ids physicians in the early diagnosis and intervention – an all-in-one platform for multiple diagnostic and therapeutic endoscopic procedures, including Stroboscopy and FEES • Greater patient satisfaction – integrated recording and playback* enhances patient and family education • Improved clinician experience – a brilliant, brighter, high-contrast image via a large HD display • Lower costs through a single unit that accommodates rigid endoscopes, flexible videoscopes, and single-use endoscopes *Integrated recording and playback will require a future software release.
www.karlstorz.com
TELE PACK + COMPACT ENDOSCOPY FOR ENT Enabling Anywhere Care – The All-in-One Diagnostic and Procedural Platform for Endoscopy
* 18.5" touch-screen with on-screen keyboard FULL HD Hygienic glass surface
LED light source Automatic and manual light intensity modes Stroboscopy
Multi-specialty for ENT, Urology, Gynecology, and more Compatible with rigid, flexible, and single-use scopes
Integrated recording and playback 50 GB internal storage Encrypted data
* Cyber secure Network capability User roles
* Integrated recording and playback and networking in the U.S. will require a future software release, and all networking functionalities will also require the STREAMCONNECT® media management application.
Ordering Information
TP101
TELE PACK +, endoscopic video unit with 2 camera inputs including: Mains Cord, length 300 cm
TH110 or TH111
IMAGE1 S™ HX/HX-P One-Chip FULL HD Camera Head, high-definition
TC001
IMAGE1 S™ Video Endoscope Adaptor
20040282
USB Flash Drive, 32 GB
9700TPX
Rolling Stand
Contact your local KARL STORZ representative for more information, or call 800-421-0837.
KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Postbox 230, 78503 Tuttlingen/Germany Phone: +49 7461 708-0 Fax: +49 7461 708-105 E-Mail: info@karlstorz.com www.karlstorz.com Caution: Federal (USA) law restricts this device to sale by or on the order of physician.
KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue El Segundo, CA 90245-5017, USA Phone: +1 424 218-8100 Phone toll free: 800 421-0837 (US only) Fax: +1 424 218-8525 Fax toll free: 800 321-1304 (US only) E-Mail: communications@karlstorz.com © 2020 KARL STORZ Endoscopy-America, Inc.
97088026 ENT 3 2.0 us 04/2020/SE-E-US
It is recommended to check the suitability of the product for the intended procedure prior to use.
“ If I had more time in my day, I’d love to spend it documenting.” – Said no one, ever.
Meet the all-in-one ENT software solution that knows how valuable your time is.
What if you could save as much as an hour and a half each day charting? What if it took your staff four minutes less per call to schedule patient appointments? What if your software helped to streamline your billing process? One of our clients decided he’d use that extra time to take on one more patient per hour. Another regained evenings with her 14-year-old daughter.* Wouldn’t it be nice just to have the option to do the one thing, or the many things, you’ve been wanting to do?
Reclaim your day with modmed® Otolaryngology. Visit modmed.com/ENTvalue or call 561.235.7506 ©2021 Modernizing Medicine, Inc.
*Results may vary and cannot be guaranteed.
As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We have provided more than 600,000 implantable devices, helping people of all ages to hear and connect with life’s opportunities. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with leading clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company.
Cochlear implant recipient, Sandy, shares her story:
©Cochlear Limited 2021. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners. Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.
www.cochlear.com/us Follow us on
My cochlear implant surgery was January 8, 2018 and my activation was about a month later. What I later discovered was the tremendous team at Cochlear. They are always ready to support. The chapter meetings are informative and helpful as well as educational. I do not think I could have made a better choice.
“
“
I struggled with sudden hearing loss in my left ear for years and then one day woke up to hearing loss in my right ear. After receiving a sensorineural hearing loss diagnosis, I got hearing aids and later a cochlear implant. Being an actress and performer, I have always adapted to new situations and my new cochlear implant is no exception.
CAM-MK-PR-521 ISS1 FEB21
In the business of providing innovative airway products Bryan Medical is excited to announce the release of their newest product line, the Tenax Laser Resistant Endotracheal Tube. Tenax has an aluminum wrapped, reinforced spiral shaft encased in a smooth sheath of flexible silicone, minimizing damage to vocal cords and related anatomy. Bryan Medical also manufactures the well-recognized Aeris Balloon Dilation Catheter. The exclusive non-slip design of the Aeris balloon ensures safe, controlled dilation of airways. Additionally, as the exclusive US distributor of TRACOE brand trach products, Bryan Medical provides only the best tracheostomy tubes, stoma stents and care products. TRACOE offers a full line of adult and pediatric tracheostomy tubes, including their newest line, TRACOE silcosoft.
Represented in your area by: Marc Cuesta, Cuesta Medical Solutions (215) 694-3231 mcuesta@cuestamed.com
Hemostasis is committed to developing and marketing innovative technologies. We work directly with leading physicians to improve procedure outcomes and enhance overall patient care. We offer a full line of Hemostat Nasal Dressings/Intranasal Splints. We offer our proprietary NOCC (N,O-carboxymethyl Chitosan) technology introduced in our flagship products PosiSep® and PosiSep®X. NexPak®X is an advanced plant-based polymer sponge developed for treating bleeding from Endoscopic Sinus Surgeries and other ENT procedures. BleedArrest®ER utilizes an innovative plant based biopolymer developed to be configured as an advanced hemostatic foam for the treatment of nose bleeds.
DISCOVER NOVAPAK™ BEYOND STRUCTURAL STABILITY Novapak™ Nasal Sinus Packing and Stent is an easy to use, natural chitosan and cellulose-based postoperative sinus surgery dressing designed to provide therapeutic benefits to help protect your patients and aid in the natural healing process.1-4
SUPPORTING THE HEALING PROCESS
The healing process after a FESS procedure is important. Novapak™ Nasal Sinus Packing and Stent is designed to deliver meaningful therapeutic benefits and antibacterial effectiveness to enhance postoperative healing.1,2 while providing structural support and stability to help reduce adhesions.1
THE SCIENCE BEHIND WOUND HEALING
1-6 DAYS INFLAMMATION Hemostasis and wound bed preparation, White blood cell mobilization at 30 days. 4-24 DAYS PROLIFERATION Granulation and re-epithelialization 24 DAYS-2 YRS DAYS MATURATION Tissue remodeling
HOW NOVAPAK™ NASAL SINUS PACKING AND STENT SUPPORTS THE HEALING PROCESS1-4 Day 11-4
Sponge absorbs fluids up to 32x times its weight Platelets aggregate Hemostasis achieved
Day 31,2
Transitions to a hydrogel Chitosan within maintains a microbial barrier with bacteriostatic properties
Day 51,2,5,6
Maintains its integrity to separate tissue and aid in the prevention of adhesions
Day 7-141,2 Dissolves
INSPIRED BY NATURE
The therapeutic properties of Novapak™ Nasal Sinus Packing and Stent can be traced to their natural source. Novapak™ contains chitosan, which is derived from chitin and found in organisms such as crustaceans and insects. Chitin is the most important polymer in exoskeletons and is well known for hemostatic properties.2-4
Natural chitosan provides antibacterial effectiveness that resists bacterial growth and provides a barrier to protect tissues from bacterial growth. It has also been shown to reduce the formation of adhesions in multiple clinical studies.5,6
CLINICAL BENEFITS OF CHITOSAN
Rapid hemostasis with fewer adhesions3-8
emostasis in the setting of coagulopathy, independent of the availability of H clotting factors and ⁄or functional platelets7
5% success rate in the rapid control of intractable epistaxis after failed standard 9 nasal packing, including patients taking antiplatelet or anticoagulant medications8
PROVEN ANTIBACTERIAL EFFECTIVENESS1,2 The Novapak™ Nasal Sinus Packing and Stent is proven effective against 18 bacterial strains shown in the table below.1 Bacterial Strain
ATCC #
Pseudomonas aeruginosa
9027
Staphylococcus epidermidis
12228
Staphylococcus aureus Echerichia coli
25923 8739
Citrobacter freundii
8090
Klebsiella pneumonia
4352
Enterobacter aerogenes Proteus mirabilis
Serratia marcescens
Haemophilus in�uenza Moraxella catarrhalis
Staphylococcus aureus (MRSA) Staphylococcus saprophyticus Micrococcus luteus
Streptococcus mutans
Streptococcus pneumoniae
Corynebacterium diphtheriae
Corynebacterium tuberculostearicum
13048 4630
13880
53782 8193
33591 15305
49732 25175
10015 296
35693
THE CHOICE OF NASAL PACKING MATTERS Choosing the right postoperative nasal packing for you and your patients matters. Novapak™ Nasal Sinus Packing and Stent is designed to provide many meaningful therapeutic benefits, is easy to use and accessible.1-2
NOVAPAK™ NASAL SINUS PACKING AND STENT IS DESIGNED TO: 1-8
Support vital tissue structures and stabilization at 48 hours
Dissolve within the nasal cavity with daily irrigation and natural mucus �ow
Absorb up to 32 times its weight in draining and bleeding of debrided mucosal surfaces Act as a hemostatic aid by absorbing and aggregating blood
Residence time is typically 7–14 days with adequate irrigation Separate tissue and maintain moisture Aid in the prevention of adhesions
EASY TO USE AND ACCESSIBLE1,2
Novapak™ Nasal Sinus Packing and Stent is pliable, compressible, springs back when hydrated, and easily manipulated during placement
O�ered in Standard and Firm con�gurations for optimal support, stability and density, enabling surgeons to tailor therapy No temperature-controlled environment required for storage or shipping
THE NOVAPAK™ DIFFERENCE: GOING BEYOND Material
Novapak™ Nasal Sinus Packing and Stent Therapeutic Bene�ts1,2 Natural (chitosan/polymer)
Antibacterial e�ectiveness
Provides a level of antibacterial e�ectiveness against 18 microbes
Absorption capacity
Absorbs Up to 32 times its weight
Shipping and storage environment
Room temperature shipping and storage
ORDERING INFO Product #
CS3600-10 CS3900-10
Description
Quantity
Novapak Firm Nasal Sinus Packing and Stent
10
Novapak™ Standard Nasal Sinus Packing and Stent ™
10
FURTHER, TOGETHER
Learn more about Novapak™ and how it can help your sinus surgery patients. Contact your Medtronic representative. References 1 2 3
4
5
6
7
8
Internal Data Available
FDA 510K, K202623.510K, Summary.Final
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. 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. 5 Internal Data Available
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. 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.
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.
Shikani AH, Chahine KA, Alqudah MA. Endoscopically guided chitosan nasal packing for intractable epistaxis. Am J Rhinol Allergy. 2011; 25(1):61-63.
Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions and contraindications. For further information, please call Medtronic ENT at 800.874.5797 or consult Medtronic’s website at medtronic.com/ent.
Medtronic ENT 6743 Southpoint Drive N Jacksonville, FL 32216 USA Toll free: (800) 874-5797 Telephone: (904) 296-9600 Fax: (800) 678-3995
© 2021 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. UC202115280a EN 03/2021
Care without compromise Stryker’s ENT portfolio of technologies offers effective treatment options that enable you to treat a broad range of patients in your preferred site of care. With Stryker, you gain access to the most complete suite of solutions to help make your vision of patient care a reality.
Chronic sinusitis and Eustachian tube dysfunction XprESS ENT dilation system
Nasal airway obstruction LATERA absorbable nasal implant system Product image is representative only and will include size markings on both the delivery device and implant tray.
Chronic rhinitis ClariFix cryotherapy device
Learn more at ent.stryker.com 4278-415 rA 07/2020 | Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: ClariFix, LATERA, Stryker and XprESS All other trademarks are trademarks of their respective owners or holders. The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.