2
the easy way to voicing The Provox System is supported by strong clinical evidence. Smooth tip - e SmartInserter has a smooth, soft and webbed tip. Preferred insertion - Clinical studies show that the SmartInserter was the clinicians’ preferred insertion method for the majority of insertions. Clinical hygiene - e SmartInserter is delivered sterile and has no loose parts, assuring hygienic insertion. No assembly or folding - e Provox Vega is pre-loaded inside the SmartInserter and is ready to use straight from the box. Voice quality improvements - Both clinicians and Provox Vega users perceived significant improvements in voice quality. Effortless speaking - Speaking with a Provox Vega voice prosthesis was less effortful. Easy and effective cleaning - e Provox Vega users found it easy to keep the voice prosthesis clean and perceived cleaning to be effective. Provox® Vega™ Voice Prosthesis Provox® SmartInserter™ e first Provox voice prosthesis was introduced in 1990. e second generation followed in 1997 and today, Provox is spread all over the world. Now we proudly present the third generation—Provox Vega voice prosthesis with SmartInserter. e standard has been raised. Airflow pioneers e development of the third generation Provox addresses issues of airflow optimization and improved maintenance. Its airflow capability makes speaking with Provox Vega even easier. Voice quality is improved by finetunings in the construction, such as its angled valve. Insertions made easier e Provox Vega voice prosthesis comes pre-loaded inside the SmartInserter. No preparations such as sterilization or assembling are needed—insertions can be performed immediately after you open the box. e design of the SmartInserter significantly reduces accidental overshooting. The Provox legacy Provox voice prostheses are renowned for their durability, good airflow capacities, and robust construction. ey are the result of a long ongoing process of careful research, testing and documentation which is the secret behind the leading position Provox products enjoy. e third generation is ready to take over. Voice prosthesis with SmartInserter™ Leading the way in ENT Atos Medical products and expertise are developed in close cooperation with leading institutions, doctors, researchers, speech language pathologists and patients from all over the world. All our claims and arguments rest on the results of clinical studies. Atos Medical started the research and development on the first Provox voice prosthesis in 1987. Throughout the years, we have worked hard to develop Provox as the leading voice and pulmonary rehabilitation system on the market. We continue to allocate substantial resources for product development and training programs for Ear, Nose and Throat specialties. Our goal is clear: Atos Medical will continue to lead the way in ENT. * Results are based on following studies: • Hancock K, Ward EC, Lawson N, van As-Brooks CJ. A RCT of two indwelling voice prostheses: Patient preferences. 2009 Nov 20; New Orleans, LA, USA: ASHA; 2009. • Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of speech production using the new indwelling Provox Vega voice prosthesis: A randomized controlled cross-over trial. Head & Neck. In press 2010. • Hilgers FJ, Ackerstaff AH, van Rossum M, Jacobi I, Balm AJ, Bing Tan I, van den Brekel MW. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).Acta Otolaryngol. 2009 Nov 7. [Epub ahead of print] • Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan B, Van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox SmartInserter). Laryngoscope. In press 2010. Best voice quality 72% 14% 14% Easiest to clean 72% 14% 14% Preferred Voice Prosthesis 66% 10% 24% Lowest speaking effort 51% 29% 20% Provox Vega Other Brand Undecided Highlights from clinical studies* Studies* have shown:

preference undecided the easy way to voicing - … · ˜ e ˚ rst Provox voice prosthesis was introduced in 1990. ˜ e second generation followed in 1997 and today, Provox is spread

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Page 1: preference undecided the easy way to voicing - … · ˜ e ˚ rst Provox voice prosthesis was introduced in 1990. ˜ e second generation followed in 1997 and today, Provox is spread

the easy way to voicingthe easy way to voicing

The Provox System is supported by strong clinical evidence.

Smooth tip- � e SmartInserter has a smooth, soft and

webbed tip.

Preferred insertion- Clinical studies show that the

SmartInserter was the clinicians’ preferred insertion method for the majority of insertions.

Clinical hygiene- � e SmartInserter is delivered sterile

and has no loose parts, assuring hygienic insertion.

No assembly or folding- � e Provox Vega is pre-loaded inside the

SmartInserter and is ready to use straight from the box.

Voice quality improvements- Both clinicians and Provox Vega users

perceived signi� cant improvements in voice quality.

E� ortless speaking- Speaking with a Provox Vega voice

prosthesis was less e� ortful.

Easy and e� ective cleaning- � e Provox Vega users found it easy

to keep the voice prosthesis clean and perceived cleaning to be e� ective.

Provox® Vega™ Voice Prosthesis

Provox® SmartInserter™

� e � rst Provox voice prosthesis was introduced in 1990. � e second generation followed in 1997 and today, Provox is spread all over the world. Now we proudly present the third generation—Provox Vega voice prosthesis with SmartInserter. � e standard has been raised.

Air� ow pioneers

� e development of the third generation Provox addresses issues of air� ow optimization and improved maintenance. Its air� ow capability makes speaking with Provox Vega even easier. Voice quality is improved by � netunings in the construction, suchas its angled valve.

Insertions made easier

� e Provox Vega voice prosthesis comes pre-loaded inside the SmartInserter. No preparations such as sterilization or assembling are needed—insertions can be performed immediately after you open the box. � e design of the SmartInserter signi� cantly reduces accidental overshooting.

The Provox legacy

Provox voice prostheses are renowned for their durability, good air� ow capacities, and robust construction. � ey are the result of a long ongoing process of careful research, testing and documentation which is the secret behind the leading position Provox products enjoy. � e third generation is ready to take over.

Voice prosthesis with SmartInserter™

Leading the way in ENT

Atos Medical products and expertise are developed in close cooperation with leading institutions, doctors, researchers, speech language pathologists and patients from all over the world. All our claims and arguments rest on the results of clinical studies. Atos Medical started the research and development on the � rst Provox voice prosthesis in 1987. Throughout the years, we have worked hard to develop Provox as the leading voice and pulmonary rehabilitation system on the market. We continue to allocate substantial resources for product development and training programs for Ear, Nose and Throat specialties. Our goal is clear: Atos Medical will continue to lead the way in ENT.

* Results are based on following studies:• Hancock K, Ward EC, Lawson N, van As-Brooks CJ. A RCT of two indwelling voice prostheses: Patient preferences. 2009 Nov 20; New Orleans, LA, USA: ASHA; 2009.• Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of speech production using the new indwelling Provox Vega voice prosthesis: A randomized controlled cross-over trial. Head & Neck. In press 2010.• Hilgers FJ, Ackerstaff AH, van Rossum M, Jacobi I, Balm AJ, Bing Tan I, van den Brekel MW. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).Acta Otolaryngol. 2009 Nov 7. [Epub ahead of print] • Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan B, Van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox SmartInserter). Laryngoscope. In press 2010.

patient future VP choice

which VP was easiest to clean

voice quality - patient preference

e�ort to speak

undecided

BS

Vega

Best voice quality

72%

14%

14%

patient future VP choice

which VP was easiest to clean

voice quality - patient preference

e�ort to speak

undecided

BS

Vega

Easiest to clean

72%

14%

14%

patient future VP choice

which VP was easiest to clean

voice quality - patient preference

e�ort to speak

undecided

BS

Vega

Preferred Voice Prosthesis

66%

10%

24%

patient future VP choice

which VP was easiest to clean

voice quality - patient preference

e�ort to speak

undecided

BS

Vega

Lowest speaking e� ort

51%29%

20%

Provox VegaOther BrandUndecided

Highlights from clinical studies*

Studies* have shown:

Page 2: preference undecided the easy way to voicing - … · ˜ e ˚ rst Provox voice prosthesis was introduced in 1990. ˜ e second generation followed in 1997 and today, Provox is spread

Reference list• Hilgers FJ, Schouwenburg PF. A new low-resistance, self-retaining prosthesis (Provox) for voice rehabilitation after total laryngectomy. Laryngoscope 1990 November;100(11):1202-7.• Hilgers FJ, Ackerstaff AH, Balm AJ, Tan IB, Aaronson NK, Persson JO. Development and clinical evaluation of a second-generation voice prosthesis (Provox 2), designed for anterograde and retrograde insertion. Acta Otolaryngol 1997 November;117(6):889-96.• Hilgers FJ, Ackerstaff AH, Balm AJ, Van den Brekel MW, Bing T, I, Persson JO. A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and “underpressure”-related replacements: Provox ActiValve. Acta Otolaryngol 2003 October;123(8):972-9.• Op de Coul BM, Hilgers FJ, Balm AJ, Tan IB, van den Hoogen FJ, van Tinteren H. A decade of postlaryngectomy vocal rehabilitation in 318 patients: a single Institution’s experience with consistent application of provox indwelling voice prostheses. Arch Otolaryngol Head Neck Surg 2000 November;126(11):1320-8.• Makitie AA, Niemensivu R, Juvas A, Aaltonen LM, Back L, Lehtonen H. Postlaryngectomy voice restoration using a voice prosthesis: a single institution’s ten-year experience. Ann Otol Rhinol Laryngol 2003 December;112(12):1007-10.• Trussart C, Lawson G, Remacle M. Voice prostheses: long-term follow-up retrospective study (three- to sixteen-year follow-up of 22 patients). Rev Laryngol Otol Rhinol (Bord ) 2003;124(5):299-304.• Hancock K, Ward EC, Lawson N, van As-Brooks CJ. A RCT of two indwelling voice prostheses: Patient preferences. 2009 Nov 20; New Orleans, LA, USA: ASHA; 2009.• Ward EC, Hancock K, Lawson N, van As-Brooks CJ. Perceptual characteristics of speech production using the new indwelling Provox Vega voice prosthesis: A randomized controlled cross-over trial. Head & Neck. In press 2010.• Hilgers FJ, Ackerstaff AH, van Rossum M, Jacobi I, Balm AJ, Bing Tan I, van den Brekel MW. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).Acta Otolaryngol. 2009 Nov 7. [Epub ahead of print] • Hilgers FJ, Ackerstaff AH, Jacobi I, Balm AJ, Tan B, Van den Brekel MW. Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox SmartInserter). Laryngoscope. In press 2010.

Provox® XtraHME• Hilgers FJM, Ackerstaff AH, Balm AJM, Gregor RT. A new heat and moisture exchanger with speech valve (Provox® [HME] Stomafi lter). Clin Otolaryngol 1996; 21: 414-418.• Hilgers FJ, Ackerstaff AH, Van As CJ, Balm AJ, Van den Brekel MW, Tan IB: Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy. Acta Otolaryngol 2003 Jan;123(1): 91-9.• Zuur JK, Muller SH, de Jongh FH, van Zandwijk N, Hilgers FJ. The physiological rationale of heat and moisture exchangers in post-laryngectomy pulmonary rehabilitation: a review. Eur Arch Otorhinolaryngol. 2006 Jan;263(1):1-8. Epub 2005 Jul 7. Review. • Zuur JK, Muller SH, Sinaasappel M, Hart GA, Van Zandwijk N, Hilgers FJ. Infl uence of heat and moisture exchanger respiratory load on transcutaneous oxygenation in laryngectomized individuals: a randomized cross-over study. Head Neck 2007 Dec; 29(12): 1102-1110.• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. Assessment of tracheal temperature and humidity in laryngectomized individuals and the infl uence of a heat and moisture exchanger on tracheal climate. Head neck 2008 Aug; 30(8): 1072-1082.• Zuur JK, Muller SH, Vincent A, Sinaasappel M, de Jongh FH, Hilgers FJ. The infl uence of a heat and moisture exchanger on tracheal climate in a cold environment. Med Eng Phys. 2009 Sep;31(7):852-7. Epub 2009 May 28. • Bien S, Okla S, van As-Brooks CJ, Ackerstaff AH. The eff ect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study. Eur Arch Otorhinolaryngol. [Epub ahead of print] 27 June 2009. • Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Zuur JK, Hilgers FJ. Endotracheal temperature and humidity measurements in laryngectomized patients: intra- and inter-patient variability. Med Biol Eng Comput. 2009 Jul;47(7):773-82. Epub 2009 May 26. • Scheenstra RJ, Muller SH, Vincent A, Sinaasappel M, Hilgers FJ. Infl uence of breathing resistance of heat and moisture exchangers on tracheal climate and breathing pattern in laryngectomized individuals. Head Neck. 2009 Dec 1. [Epub ahead of print]• Scheenstra RJ, Muller SH, Vincent A, Ackerstaff AH, Jacobi I, Hilgers FJM. Short term endotracheal climate changes and clinical eff ects of a heat and moisture exchanger with an integrated electrostatic virus and bacterial fi lter developed for laryngectomized individuals. Acta Otolaryngologica 2009, [Epub ahead of print] December 10.• van den Boer C, Muller SH, Vincent A, Ackerstaff AH, Jacobi I, Scheenstra RJ, van den Brekel MWM, Hilgers FJM. Postlaryngectomy tracheal climate effects and clinical feasibility of a new generation Heat and Moisture Exchangers (Provox XtraMoist and XtraFlow). Manuscript in preparation.The above references represent a selection. For more information contact Atos Medical AB or your local representative.

The complete catalog of the Provox System can be downloaded from www.atosmedical.com

Other sources of information:More about the Provox System, including trouble shooting: www.provoxweb.info More about rehabilitation of olfaction after total laryngectomy: www.hoofdhals.nki.nl/olfaction/Start.aspx

Atos Medical ABP.O. Box 183, SE-242 22 Hörby, SwedenTel: +46 (0)415 198 00 Fax: +46 (0)415 198 [email protected]

Sales o� ces:

Head o� ce:

© Atos Medical AB, Sweden. 201003A, REF 7870

Quantity REF

Provox LaryClip 1 set: 8 pcs LaryClip, 40 pcs LaryClip Base

7669

Quantity REF

Provox XtraBase 20 pcs 7265

FlexiDerm Oval 20 pcs 7254

FlexiDerm Round 20 pcs 7253

OptiDerm Oval 20 pcs 7256

OptiDerm Round 20 pcs 7255

Voice prosthesis with SmartInserter™

Provox Vega Prosthesis REF Rx**

Provox Vega 17Fr 4mm 8110* Rx

Provox Vega 17Fr 6mm 8111* Rx

Provox Vega 17Fr 8mm 8112* Rx

Provox Vega 17Fr 10mm 8113* Rx

Provox Vega 17Fr 12.5mm 8114* Rx

Provox Vega 17Fr 15mm 8115* Rx

Provox Vega 20Fr 4mm 8120* Rx

Provox Vega 20Fr 6mm 8121* Rx

Provox Vega 20Fr 8mm 8122* Rx

Provox Vega 20Fr 10mm 8123* Rx

Provox Vega 20Fr 12.5mm 8124* Rx

Provox Vega 20Fr 15mm 8125* Rx

Provox Vega 22.5Fr 4mm 8130 Rx

Provox Vega 22.5Fr 6mm 8131 Rx

Provox Vega 22.5Fr 8mm 8132 Rx

Provox Vega 22.5Fr 10mm 8133 Rx

Provox Vega 22.5Fr 12.5mm 8134 Rx

Provox Vega 22.5Fr 15mm 8135 Rx

Provox Vega accessories

Provox Vega Plug 17Fr 8119*

Provox Vega Plug 20Fr 8129*

Provox Vega Plug 22.5Fr 8139

Provox Flush 8109

Provox Brush 7204

Provox Brush XL 7225

Provox Dilator 7211

Provox Dilator 17 7122*

Provox Dilator 20 7123*

Quantity REF Rx**

Provox XtraMoist HME 5 pcs 7297

Provox XtraFlow HME 5 pcs 7298

Provox XtraMoist HME 30 pcs 7290

Provox XtraFlow HME 30 pcs 7291

Provox Micron HME 5 pcs 7247 Rx

Provox Micron HME 30 pcs 7248 Rx

Provox HME Cassette Adaptor* 7246

Ordering Information

Provox® is a registered trademark owned by Atos Medical AB, Sweden. Provox® Vega™ is protected by US 5.314.470, US 5.976.151, JP 9-523 567 and other patents and patents pending. Provox® HME is covered by US 5 738 095, US 5.042.468, JP 3.553.955, CA 2.179.661 and other patents.

* not available on all markets

Asia - Paci� c:Atos Medical ABRoom 1003, 10th FloorWorld-Wide House19 Des Voeux RoadCentral, Hong KongTel: +852 3656 7780Fax: +852 3656 [email protected]

Belgium: Atos Medical BVBA / SPRL Koningsstraat 266 Rue Royale BE - 1210 Brussel / BruxellesTel: 02 / 218 55 50 Fax: 02 / 218 55 51 [email protected]

Germany:Atos Medical GmbH Mülheimer Strasse 3-7 DE-53840 TroisdorfTel: +49 02 24 1 1493-0Fax: +49 02 24 1 [email protected]

The Netherlands:Atos Medical B.V.Postbus 574 NL - 2700 AN ZoetermeerTel: (0)79 593 5000 Fax: (0)79 593 [email protected]

Spain:Atos Medical Spain S.L. Aragón 208-210, 3o 3a ES-08011 Barcelona, EspañaTel: 93 323 9196 Fax: 93 451 3695 [email protected]

Switzerland: Atos Medical, Switzerland Mainaustrasse 15 CH-8008 Zürich, SchweizTel: +41 (0) 44 380 60 90Fax: +41 (0) 44 380 60 [email protected]

U.K.:Platon Medical LtdP.O. Box 2568, EastbourneEast Sussex BN21 3HZ, Tel: 01323 431 930Fax: 01323 732 [email protected]

U.S.:Atos Medical Inc.11390 West Theodore Trecker WayWest Allis, WI 53214-1135, USA Customer Service: 1-800 217 0025Fax: 1-414 227 [email protected]

**In applicable countries

Pressure Drop (Pa) at 30l/min(Lower value = easier to breathe)

20 706050403010 80

XtraMoist

XtraFlow

Normal

HiFlow

Moisture Output (mg/l)(Higher value = better humidifaction)

18 232221201917 24

XtraMoist

XtraFlow

Normal

HiFlow

Provox® XtraHME™ The next generation of HME Cassettes� e � rst Provox HME Cassettes were introduced in 1995. � e Provox HME has set the standard, and is the most extensively clinically tested HME for laryngectomees in the world. Now we are proud to present the next generation of HME Cassettes; the Provox XtraHME. Now with even better humidi� cation from which many patients breathing through a tracheostoma will bene� t.

Improved features� e Provox XtraHME is available in two versions:

XtraMoist HME has capacities close to normal nasal function. � e humidi� cation is improved and the XtraMoist is still keeping the good air� ow for easy breathing. XtraMoist is recommended for patients who have recently undergone a total laryngectomy, and for accustomed users.

XtraFlow HME is focusing on having superior air� ow. XtraFlow is great to use when exercising and when adapting to the breathing resistance after having been without an HME for a longer time.

Many users experience the following bene� ts of using an HME:• Reduced mucus production• Reduced coughing• Improved pulmonary function• Improved speech• Hygienic stoma occlusion• Improved quality of life

Side openings for secure breathing

Can - and should - be used both day and night

Increased volume of highly e� cient HME media

Easy, and silent, occlusion of the stoma for voicing Discreet color

Low pro� le design

Protective rimreduces risk foraccidential closure

Choosing voice prosthesis• Provox Vega• Provox ActiValve

Choosing HME• XtraMoist• XtraFlow• Micron

Attaching the HME• Adhesive• LaryButton• LaryTube

Finding an individual combination of voice prosthesis, HME and attachment is important for good speech and pulmonary rehabilitation.

The Provox System has a wide range of products, assuring that an optimal combination of the three can be obtained for every person.

Combination of three

Antimicrobial

Pressure Drop (Pa) at 30l/min(Lower value = easier to breathe)

20 706050403010 80

XtraMoist

XtraFlow

Normal

HiFlow

Moisture Output (mg/l)(Higher value = better humidifaction)

18 232221201917 24

XtraMoist

XtraFlow

Normal

HiFlow

Designed for easy removal of mucus

XtraFlow

XtraMoist