T RA N SA N A L ACC E S S P L AT FO R M

A New Generation Medical Device Company

CONTENTS:

Features and Benefits

Clinical References

Education and Training

©2016 Applied Medical Resources Corporation. All Rights Reserved. Applied Medical, the Applied Medical logo design, GelPOINT and GelSeal are U.S. registered trademarks of Applied Medical Resources Corporation. SC01504H

For more information and resourceswww.appliedmedical.com/gelpoint

http://contact.appliedmedical.com/

The GelPOINT path transanal access platform enables insufflated access to the rectum

and lower sigmoid colon for surgical procedures including Transanal Minimally Invasive

Surgery (TAMIS). GelPOINT path allows utmost versatility and access.

GelPOINT Path Transanal Access Platform

Self-retaining sleeves maintain pneumorectum while allowing the exchange of 5-10mm instruments

Removable cap provides simple specimen removal, versatility in port placement and maintenance of pneumorectum using renowned GelSeal® technology

Two interchangeable insufflation/smoke evacuation ports feature luer fittings and stopcock valves to accommodate standard laparoscopic insufflation and facilitate smoke evacuation

4cm diameter access channel provides maximum working space and dilation

Suture tabs for added security

Features and Benefits

Features and Benefits

Feature Benefits ∙ Provides a flexible fulcrum for unmatched triangulation of standard laparoscopic instrumentation

∙ Maintains pneumorectum for continuous access

∙ Two interchangeable insufflation/smoke evacuation ports feature luer fittings and stopcock valves to accommodate standard laparoscopic insufflation and facilitate smoke evacuation

∙ Facilitates large specimen removal with simple detachment from access channel

∙ Saves valuable OR time with simple placement and set-up

∙ Offers 4cm atraumatic retraction for enhanced exposure and access

∙ Includes retention flange and suture ties for maximum security throughout procedure

Self-Retaining Sleeves

∙ Accommodates 5-10mm standard laparoscopic instrumentation, 5mm angled instrumentation and curved suture needles

∙ Offers greater freedom of movement and less instrument collision due to low-profile design

GelSeal® Cap

Access Channel with Introducer

GelPOINT Path Components

GelSeal Cap 7.5cm diameter 1Access Channel with Introducer 4cm x 5.5cm 1Self-Retaining Sleeves 10mm 4Obturator 10mm 1

Model Number Description Size Quantity

CNO11 GelPOINT Path 4cm x 5.5cm 1/BOX

Clinical References

Transanal Minimally Invasive Surgery (TAMIS)

“TAMIS provides a reasonable low-cost option to TEM without compromising the clear advantage of microsurgery.”

Transanal minimally invasive surgery: a giant leap forward. Atallah S, Albert M, Larach S. Surg Endosc. 2010; DOI:10:1007/s00464-010-0927-z.

Clinical References

Transanal Endoscopic Video-Assisted Excision (TEVA)

“TEVA excision offers several potential benefits over TEM, including a lower learning curve and a reduced cost.”

Transanal Endoscopic Video-Assisted Excision: Application of Single-Port Access. Madhu Ragupathi, Eric M. Haas., JSLS. 2011 Jan-Mar: Vol 15: Num 15: 53-58

“TEVA excision may emerge as a favorable cost-effective modality for palliative cases in patients not able to tolerate more invasive procedures, such as LAR or APR.”

Clinical References

Transanal Minimally Invasive Surgery (TAMIS)

Transanal Minimally Invasive Surgery (TAMIS) for Local Excision of Benign Neoplasms and Early-stage Rectal Cancer: Efficacy and Outcomes in the First 50 Patients. Albert M., Atallah S., deBeche-Adams, T., Izfar S., Larach S. Dis Colon Rectum 2013;56:301-307.

“TAMIS is a safe and effective advanced transanal platform for the local excision of benign adenomas and well-selected early-stage rectal cancer.”

“Patient outcomes and resection quality appear to be similar to those obtained with TEM; thus, TAMIS is a valid low-cost alternative to this established platform.”

Clinical References

Transanal Endoscopic Microsurgery

“The economic evaluation showed TEM to incur approximately two-thirds the recurrent cost of the alternative standard procedures for adenomas, and approximately one-half the recurrent costs for carcinomas.”

Transanal Endoscopic Microsurgery: A Systematic Review. Middleton P., Sutherland L., Maddern G. Dis Colon Rectum 2005; 48:270-284

“Although no differences between TEM and radical resection could be detected for most outcomes, decreased pain and the likely shorter hospital stay will be attractive to patients and clinicians.”

Education and Training

GelPOINT Path Transanal Minimally Invasive Surgery (TAMIS) Workshops

TAMIS gives the colorectal surgeon the ability to expand their skills to

include the use of local excision from the distal rectum to the mid and

proximal rectum. TAMIS enables the resection of benign and malignant

lesions in the rectum using new advanced access devices and standard

laparoscopic instrumentation.

Applied Medical is pleased to partner with leading colorectal surgeon

proctors across the United States to offer one-day courses designed for

advanced laparoscopic colorectal surgeons who wish to explore TAMIS

using the GelPOINT path transanal access platform. Courses include

a didactic session, live TAMIS surgeries, and a hands-on workshop.

Participants will gain a comprehensive understanding of TAMIS procedural

techniques and instrumentation.

Course Objectives:• Indications for TAMIS

• Anatomy as it relates to TAMIS

• Operative instrumentation

and room setup

• Patient selection, benefits, risks

and challenges

• Pre-op protocol

• Anesthesia considerations

• Patient positioning

• TAMIS technique

• Post-op patient treatment

• Patient education and

reimbursement

Education and Training

W O R K S H O PTRANSANAL MINIMALLY INVASIVE

TRANSANAL MINIMALLY INVASIVE

TRANSANAL MINIMALLY INVASIVE

SURGERY (TAMIS)SURGERY (TAMIS)SURGERY (TAMIS)SURGERY (TAMIS)

Transanal Minimally Invasive Surgery (TAMIS) gives the

Colorectal surgeon the ability to expand their skills to

include the use of local excision from the distal rectum

to the mid and proximal rectum. TAMIS enables the

resection of benign and malignant lesions in the

rectum using new advanced access devices and

standard laparoscopic instrumentation.

This one-day course is designed for advanced

laparoscopic colorectal surgeons who wish to explore

TAMIS using the GelPOINT® path transanal access

platform. The course will include a didactic session

and a hands-on workshop. Participants will gain a

comprehensive understanding of TAMIS procedural

techniques and instrumentation. The program is

limited to 16 participants to maximize the hands-on

experience.

COURSE DESCRIPTION

A New Generation Medical Device Company

7th December 2013

LOCATIONApplied Medical Europe B.V

Wiekenweg 21

3815 KL, Amersfoort

The Netherlands

RE

GIS

TR

AT

ION

FO

RM

Gel

POIN

TSM p

ath

TAM

IS W

orks

hop/

Inte

rnat

iona

l Min

imal

Acc

ess

Cen

tre

For

Surg

ery

Nam

e

Addr

ess

Post

code

Phon

e

Emai

l

Late

x G

love

Alle

rgy?

MA

IL T

O:

Appl

ied

Med

ical

Eur

ope

B.V

– At

tn J

olan

da D

e Ri

dder

, Wie

kenw

eg 2

1, 3

815K

L, A

mer

sfoo

rt, T

he N

ethe

rland

s

SCA

N &

EM

AIL

TO

: jde

ridde

r@ap

plie

dmed

ical

.com

FAX

TO:

+31

(0) 3

3 42

2 90

49

TEL:

+31

(0) 3

3 75

1 77

71

PLEA

SE P

RIN

T C

LEA

RLY

7th D

ecem

ber

2013

Plea

se m

ake

a ba

nk tr

ansf

er fo

r €3

00.0

0

and

men

tion

TAM

IS C

ours

e in

the

refe

renc

e

ABN

AM

RO b

ank

Bank

acc

ount

: 400

8198

99

IBAN

: NL3

7ABN

A040

0819

899

BIC

(sw

ift):

ABN

ANL2

A

PAYM

ENT

MET

HO

D (

Regi

stra

tion

fee

€300.0

0)

�

pathSM

LOCATION

Applied Medical Europe B.V.

Wiekenweg 21

3815 KL, Amersfoort

The Netherlands

REGISTRATION FORM

Please make a bank transfer for €300.00 and mention

“TAMIS Course + your name and date of the course”

in the reference

ABN AMRO bank

Bank account: 400819899

IBAN: NL37ABNA0400819899

BIC (swift): ABNANL2A

GelPOINT path TAMIS Workshop

International Minimal Access Centre For Surgery

TRRRRTRRANNNNAAAAAAANA SASASSANANAAAAANANAAAN LLLLLL MMIMIMIM NIIINIMMAAAAMAAMMMAMM LLLLLLLLLLLLLLL YYYYYYYYY INNINNVVAVAVVAASSISISISIIS VEVEEVEVEV SSSSSSSURRRRU GGGEGERY (TAAAMIMIM S)S)

TRANSANAL MINIMALLY INVASIVE SURGERY (TAMIS)

WORKSHO

P

Payment Method (Registration fee €300.00)

DIGITAL FORM THAT CAN BE FILLED IN DIRECTLY

Name

Hospital Address

Postcode

Phone

Email

Medical License #

Your Information

Date of the Course

EMAIL: ClinicalEducation-Europe@appliedmedical.com

TEL: +31 33 754 8706

SM

Transanal Minimally Invasive Surgery (TAMIS) gives the colorectal

surgeon the ability to expand their skills to include the use of local

excision from the distal rectum to the mid and proximal rectum.

TAMIS enables the resection of benign and malignant lesions in the

rectum using new advanced access devices and standard

laparoscopic instrumentation.

This one-day course is designed for advanced laparoscopic colorectal

surgeons who wish to explore TAMIS using the GelPOINT® path

transanal access platform. The course will include a didactic session

and a hands-on workshop. Participants will gain a comprehensive

understanding of TAMIS procedural techniques and instrumentation.

The program is limited to 16 participants to maximize the hands-on

experience.

Learn how the GelPOINT® path transanal access platform enables

Transanal Minimally Invasive Surgery (TAMIS) for the treatment of rectal

neoplasms. Explore tools and techniques including:

Indications for TAMIS

Anatomy as it relates to TAMIS

Operative instrumentation and room setup

Patient selection, benefits, risks and challenges

Pre-op protocol

Anesthesia considerations

Patient positioning

TAMIS technique

Post-op patient treatment

Patient education and reimbursement

COURSE OBJECTIVES

COURSE DESCRIPTION

SM