pentax medical the wavstat4™ optical biopsy system. · does the laser light hurt or cause damage...

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PENTAX Nederland B.V. Amsterdamseweg 29 1420 CA Uithoorn Netherlands Tel.: +31 88 / 5 30 30 30 Fax: +31 88 / 5 30 30 40 E-mail: [email protected] PENTAX Italia S.r.l. Via Dione Cassio, 15 20138 Milano Italy Tel.: +39 / 02 50 99 58 1 Fax: +39 / 02 50 99 58 60 E-mail: [email protected] SIMMEDICA – Sistemas Integrales de Medicina, S.A. Avenida del Sistema Solar 25 28830 San Fernando de Henares · Madrid Spain Tel.: +34 91 / 301 62 40 Fax: +34 91 / 751 31 15 E-mail: [email protected] PENTAX Europe GmbH Representative office in Moscow Sadovnicheskaya str, 82, build 2, entrance 6 Regus, Business center „Aurora“ Office 2012, 2013 Moscow, 115035 Russian Federation Tel.: +7 495 / 792 52 00 Fax: +7 495 / 792 35 66 PENTAX Turkey Veko Giz Plaza, Meydan Sokak No:3/43 343396 Maslak – Istanbul Turkey Tel.: +90 212 / 705 05 26 Fax: +90 212 / 705 05 00 HOYA Corporation PENTAX Life Care Division 1-1-110, Tsutsujigaoka Akishima-shi 196-0012 Tokyo Japan Tel.: +81 3 / 39 60 51 55 Fax: +81 3 / 53 92 67 24 PENTAX Europe GmbH Julius-Vosseler-Straße 104 22527 Hamburg Germany Tel.: +49 40 / 5 61 92 - 0 Fax: +49 40 / 5 60 42 13 E-mail: [email protected] PENTAX U.K. Limited PENTAX House Heron Drive, Langley Slough SL3 8PN United Kingdom Tel.: +44 17 53 / 79 27 33 Fax: +44 17 53 / 79 27 94 E-mail: [email protected] PENTAX France Life Care S.A.S. 112 quai de Bezons B.P. 204 95106 ARGENTEUIL CEDEX France Tel.: +33 1 / 30 25 94 78 Fax: +33 1 / 30 25 74 45 E-mail: [email protected] In the interest of technical progress, specifications may change without notice. PENTAX Medical The WavSTAT4™ Optical Biopsy System. One second confirmation. Manufacturer: Spectra Science Inc. 11568 Sorrento Valley Rd 11 San Diego, CA 92121 Tel.: +1 858-847-0200 Email: [email protected] LCM/01/10/13/320169/02

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Page 1: PENTAX Medical The WavSTAT4™ Optical Biopsy System. · Does the laser light hurt or cause damage to tissue? No. The WavSTAT4™ Optical Biopsy System operates at a very low level

PENTAX Nederland B.V.Amsterdamseweg 291420 CA UithoornNetherlandsTel.: +31 88 / 5 30 30 30Fax: +31 88 / 5 30 30 40E-mail: [email protected]

PENTAX Italia S.r.l.Via Dione Cassio, 1520138 MilanoItalyTel.: +39 / 02 50 99 58 1Fax: +39 / 02 50 99 58 60E-mail: [email protected]

SIMMEDICA – Sistemas Integralesde Medicina, S.A.Avenida del Sistema Solar 2528830 San Fernando de Henares · MadridSpainTel.: +34 91 / 301 62 40Fax: +34 91 / 751 31 15E-mail: [email protected]

PENTAX Europe GmbHRepresentative office in MoscowSadovnicheskaya str, 82, build 2, entrance 6Regus, Business center „Aurora“Office 2012, 2013Moscow, 115035Russian FederationTel.: +7 495 / 792 52 00Fax: +7 495 / 792 35 66

PENTAX TurkeyVeko Giz Plaza, Meydan SokakNo:3/43 343396Maslak – IstanbulTurkeyTel.: +90 212 / 705 05 26Fax: +90 212 / 705 05 00

HOYA CorporationPENTAX Life Care Division1-1-110, TsutsujigaokaAkishima-shi196-0012 TokyoJapanTel.: +81 3 / 39 60 51 55Fax: +81 3 / 53 92 67 24

PENTAX Europe GmbHJulius-Vosseler-Straße 10422527 HamburgGermanyTel.: +49 40 / 5 61 92 - 0Fax: +49 40 / 5 60 42 13E-mail: [email protected]

PENTAX U.K. LimitedPENTAx HouseHeron Drive, LangleySlough SL3 8PNUnited KingdomTel.: +44 17 53 / 79 27 33Fax: +44 17 53 / 79 27 94E-mail: [email protected]

PENTAX France Life Care S.A.S.112 quai de BezonsB.P. 20495106 ARGENTEUIL CEDExFranceTel.: +33 1 / 30 25 94 78 Fax: +33 1 / 30 25 74 45E-mail: [email protected]

In the interest of technical progress, specifications may change without notice.

PENTAX Medical The WavSTAT4™ Optical Biopsy System.One second confirmation.

Manufacturer:Spectra Science Inc.11568 Sorrento Valley Rd 11San Diego, CA 92121Tel.: +1 858-847-0200Email: [email protected]

LCM

/01/

10/1

3/32

0169

/02

Page 2: PENTAX Medical The WavSTAT4™ Optical Biopsy System. · Does the laser light hurt or cause damage to tissue? No. The WavSTAT4™ Optical Biopsy System operates at a very low level

Frequently Asked Questions. Optical biopsy forceps. Confirmation of adenomatous tissue within a second.

What is an optical biopsy?

An optical biopsy involves the use of a safe low power laser light that shines on an area of suspect tissue or a protruding polyp. Since suspect tissue absorbs and reflects light differently than normal tissue, the light signal can be objectively analysed by the WavSTAT4™ Optical Biopsy System. In a second, the light signature is analysed and provides physicians with a coloured light prompt. If the signal is red (suspect tissue), biopsy forceps attached to the optical probe can be closed to take an immediate tissue biopsy, or simply remove the observed polyp.

What are the benefits of having an optical biopsy?

The ability to evaluate smaller or flat polyps is of growing concern. In the past, smaller polyps (<1cm) and flat polyps were only evaluated through visual inspection and enhanced imaging. The WavSTAT4™ Optical Biopsy System provides instant information that was never available before, versus a tissue biopsy that could be collected and later analysed by a pathologist.

The The WavSTAT4™ Optical Biopsy System may also lead to better classification of risk, which can help determine the most appropriate time interval for future screening procedures.

Why have an optical biopsy as part of your colonoscopy procedure?

By adding the power of an optical biopsy to a standard colonoscopy procedure, additional areas of concern beyond the removal of large polyps are now being analysed and identified earlier. In the case of smaller or flat polyps not currently considered for removal or biopsy, the physician now has a powerful new tool to help make objective decisions.

Does the laser light hurt or cause damage to tissue?

No. The WavSTAT4™ Optical Biopsy System operates at a very low level of UV light. Unlike more powerful lasers used for hair removal or other medical procedures, the WavSTAT4™ Optical Biopsy System does not damage tissue or cause pain.

The WavSTAT4™ Optical Biopsy System offers a simplified yet highly effective way of rapid confirmation of uncertain lesions as colorectal cancer in an early stage, when recovery rates are high. This innovative

technology instantly and accurately confirms if tissue is normal, neoplastic or non-neoplastic. It allows the real-time prediction of adenomatous colorectal tissue.

The WavSTAT4™ Optical Biopsy System utilises laser-induced fluorescence spectroscopy and an optical fibre to transmit laser light via the flexible endoscope to the tissue. The fluorescence light from the tissue returns to an optical detector for analysis and displays a binary message: “Suspect” or “Non Suspect”.

The WavSTAT4™ Optical Biopsy System is a promising technology for interpreting uncertain polypoid struc-tures objectively. It has the potential to support the diagnostic and therapeutic pathway and reduce un-necessary polypectomies with possible side-effects and potentially supports resect and discard strategies. The system is compatible with existing endoscopic equip-ment and is FDA and CE Mark certified.

Key advantages

• Confirmation in one second and rapid computerised prediction of histology in colorectal lesions

• Objective interpretation of polyp structure to reduce false negative rates

• Easy operation by performing optical and physical biopsies with the same forceps

• Potential to reduce costs, time and risks associated with the redundant removal of diminutive hyperplastic lesions

Specifications

Console

Electrical input voltage (VAC) 100-240

Electrical input frequency (Hz) 50-60

Dimensions (mm) 1111 x 622 x 622

Weight (Kg) 45.5

Laser (mm) 337.1 Nitrogen Pulsed

Optical Biopsy Forceps

Diameter (mm) Ø 2.4

Working length (mm) 2,300