Advanced Therapeutics

02
Advanced Therapeutics
table of contents

02-1 ESD Accessories

02-2 TOP Endoscopic Hoods

02-3 C2 CryoBalloon™ Ablation System

 For time-efficient and
safe procedures.
PENTAX Medical ESD accessories are innovative,
easy to handle and highly controllable for any kind
of dissection of the entire GI tract.

A full range of ESD accessories for a complete dissection.

PENTAX Medical accessories cover all steps of the ESD procedure and can be perfectly
combined with the PENTAX Medical RetroView scope, with its unique 210° deflection ability
and reduced bending radius of its distal end, for a safe and time-efficient dissection.

Marking, marginal incision, dissection

and hemostasis with Splash M-Knife

Splash M-Knife is a unique multi-functional

accessory allowing complete ESD procedures
with a single device.

Marking Resection
It has been developed and designed to achieve clear
marking, better hemostasis and smoother and
easier operation with fixed knife length and hooking
mechanism. Splash M-Knife is designed to improve
hemostasis ability with better bleeding control during
a procedure without replacing the knife.

Dissection Hemostasis
 Hemostasis with the bipolar HemoStat WideCup
The HemoStat WideCup is used to accomplish effective initial hemostasis for gastrointestinal
bleeding.

The bipolar forceps device is designed to support fast and efficient hemostasis without
causing damage to the deeper tissue through thermal degeneration. The HemoStat WideCup
is expected to aid prevention of re-bleeding, especially during ESD.*1
*1
 Kataoka et al. “Clinical evaluation of emergency endoscopic hemostasis with bipolar forceps in non-variceal upper gastrointestinal bleeding”
M
Digestive Endoscopy (2010) 22, 151-155

Dissection with Mucosectom

With its innovative design, Mucosectom overcomes the
­challenges of dissection procedures safely and efficiently.

The insulated tip can reduce the risk of perforation, while

the extended knife length can reduce the amount of time
the procedure takes.*2 The knife on the side of the 360° rotatable
tip and the optical marker are designed to assist the physician
in holding the accessory in the direction of the lesion and
dissecting it precisely.
Hiromitsu Kanzaki MD1, Ryu Ishihara MD1, Takashi Ohta MD1, Kengo Nagai MD1, Fumi Matsui MD1, Takeshi Yamashina MD1, Masao Hanafusa MD1, Sachiko
*2 

Yamamoto MD1, Noboru Hanaoka MD1, Yoji Takeuchi MD1, Koji Higashino MD1, Noriya Uedo MD1, Hiroyasu Iishi MD1 and Masaharu Tatsuta MD1 “Randomized
Study of Two ­Endo-knives for Endoscopic Submucosal Dissection of Esophageal Cancer“ The American Journal of Gastroenterology 2013 Aug;108(8):1293-8.
doi: 10.1038/ajg.2013.161. Epub 2013 Jun 4
 02-1 ESD Accessories

PENTAX Medical ESD –

precise, efficient and safe.

INNOVATIVE
DESIGN
Splash M-Knife: Multi-functional device for a complete ESD
Marginal Submucosal
Marking Hemostasis*3
Incision Dissection

• Disk in the knife helps to hook up the tissue for improved safety
and ease of cutting
• Metal plate that closes the knife for clear marking and
better hemostasis
• Water jet function that enables additional injection without changing
the device
*3 Major bleeding needs to be stopped by a clip or hemostasis forceps such as HemoStat WideCup

INNOVATIVE
DESIGN
Mucosectom: For a safe and fast therapeutic approach
Marginal Submucosal
Marking Hemostasis
Incision Dissection

• Insulated tip and single-sided knife designed for a safer dissection

• Rotatable tip with optical marker supports a precisely directed dissection
• Extended knife length designed for a faster procedure*4
*4 Kawahara Y, Imagawa A, Fujiki S, Shiratori Y. “Novel procedure of endoscopic submucosal dissection (ESD)
using a new device (mucosectome) for early esophageal cancer” Gastrointest Endosc. 2006;63:AB222

Ksnare: All-in-one
Marginal Submucosal
Marking Hemostasis
Incision Resection

• Enables hybrid techniques EMR/ESD especially in the colon

• Combines an adjustable knife on the tip designed for precise marking
and incision, and a snare for resection
• The all-in-one accessory for supporting a complete lesion resection
 INNOVATIVE
BIPOLAR DESIGN
Bipolar HemoStat WideCup: Easy control of bleeding
Marginal Submucosal
Marking Hemostasis
Incision Dissection

• Bipolar HemoStat WideCup reduces the impact of deeper tissue

thermal degeneration*5
• Supports prevention of re-bleeding*6
• Based on its flexibility, it can be used for various applications such
as EMR/ESD, gastrointestinal bleeding and papilla resection
*5 Compared with monopolar forceps
*6 M Kataoka et al. “Clinical evaluation of emergency endoscopic hemostasis with bipolar forceps in
non-variceal upper gastrointestinal bleeding“ Digestive Endoscopy (2010) 22, 151-155

Model Item Working Min. Max. Knife Adjus- Snare/ Packaging

name number Length Channel Insertion Length table Cup
[mm] [mm] Portion [mm] Knife Opening
Width Length [mm] Single Boxes
[mm] [mm] unit of 5
Extended 2.0
Splash M-Knife DN-D2718B 80387 1,800 2.8 2.7 X

Retracted 0.5
X

Extended 2.0
DN-D2722B 80396 2,200 2.8 2.7 X

Retracted 0.5 X

Mucosectom DP-D2518 47662 1,800 2.8 2.5 5.0 X

DP-D2622 47902 2,200 2.8 2.6 2.5 X

Ksnare DO-D2618 47905 1,800 2.8 2.6 6.0 2.0-6.0 22 X

DO-D2622 47908 2,200 2.8 2.6 6.0 2.0-6.0 22 X

HS-D2618 80942 1,800 2.8 2.6 5.8 X

HemoStat
WideCup*7
HS-D2622 80940 2,200 2.8 2.6 5.8 X

*7 Equipped with active cord and plug

Consult your local representative for information on the products currently available in your region.
 TOP ENDOSCOPIC HOOD
The slit and hole allows quick fluid
outlet from the hood.

©2012 TOP Corporation

Slit and Hole

Fluid in the hood is discharged by capillarity and pressure difference.

How to use
1. Attachment direction

Attach the hood to the scope in the direction shown

by the arrow. Avoid attaching upside down. The
attachment side is thinner, with matching endoscope
diameter indicated. ©2012 TOP Corporation

2. Securing with tape

Secure the loose attachment (e.g. unstable hood)

with tape. Avoid covering the side hole with the
tape.
©2012 TOP Corporation

Lubricant jelly may clog the side hole, preventing fluid outlet.
 02-2 TOP Endoscopic Hoods

Straight type

Model Item Compliant endoscope O.D. Drainage Packaging

name number function unit

SS 306030 8.6~9.8 mm
Off 5pcs./box
SS SL SL 306031 10.6~12.6 mm

Slit and Hole type

Model Item Compliant endoscope O.D. Drainage Packaging

name number function unit

SHLL-B 306032 12.6~14.0 mm On 5pcs./box

Slit and Hole F(Focus) type

Model Item Compliant endoscope Hood Drainage Packaging

name number O.D. protrusion function unit
length

SHF-010 306025 9.0~9.2 mm

SHF-025 306026 9.8~9.9 mm
SHF-030 306027 9.9~10.5 mm
SHF-035 306028 10.8 mm 3.5~7.0 mm On 5pcs./box
SHF-050 306033 11.7~12.2 mm
SHF-055 306034 12.8 mm
SHF-060 306029 13.2 mm

Manufactured by

Ask your local sales representative about compatibility with the PENTAX Medical endoscopes.
In order to select the compatible TOP Hood for your endoscope, please consider that variation
of the nominal scope size may occur after service and repair.
Some of the above products may not be available in all countries. Please consult your local representative for further information.
 The C2 CryoBalloonTM Ablation System

C2 CryoBalloon™ Ablation System has not been commercially released in all

For the Endoscopic Cryoablation of Barrett’s

European countries. Please contact your local sales rep to learn more.
Esophagus*
*Cleared in US, Europe and Canada

The C2 CryoBalloon™ Ablation System is used to destroy diseased/

unwanted tissue by applying extreme cold. A balloon catheter is
positioned in the area of the diseased tissue and the compliant balloon
is then inflated to contact the esophageal wall circumferentially. The
diffuser, within the expanded balloon, is then guided for ablation
by pointing the diffuser outlet to deliver nitrous oxide directly at the
targeted tissue. The extreme cold eradicates the targeted precancerous
or abnormal lesions by a cryogenic heat transfer process between the
balloon and the esophageal lining delivering a controlled therapy ablating
only the targeted lesions. The system allows physicians complete control Circumferential ablation of the gastroesophageal junction.
of the procedure with direct visualization of the treatment area during the Courtesy of Dr. Haidry, University College Hospital, London

procedure, which lasts between 15 to 30 minutes.[1] ,[2]

[1] Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal Nitrous Oxide
Cryoballoon Ablation with or without EMR for Treatment of Neoplastic Barrett’s Esophagus. Gastrointest Endosc.
2018 Apr 4; pii: S0016-5107(18)30259-1. doi: 10.1016/j.gie.2018.03.024. PMID: 29626424
[2] Künzli HT, Schölvinck DW, Meijer SL, Seldenrijk KA, Bergman JGHM, Weusten BLAM. Efficacy of the CryoBalloon
Focal Ablation System for the Eradication of Dysplastic Barrett’s Esophagus Islands. Endoscopy. 2017 Feb;49(2):
169-175. doi: 10.1055/s-0042-120117. Epub 2016 Dec 20. PMID: 27997963

How does the cryoablation work?

[3]

[3] Baust, J.G; Gage, A.A; Bieklund Johansen, T.E and Baust, J.M. Mechanisms of Cryoablation: Clinical Consequences on Malignant Tumors; Cryobiology. 2014 Feb. 68(1): 1-11
 The new C2 CryoBalloon™ Ablation System offers several key advantages including
the ability to ablate a wide range of patients, enhanced visualization and control as
the a­ blation catheter is deployed through the working channel of the endoscope.
“With the C2 CryoBalloon™ Ablation System, you can promote your practice as a
more comprehensive Barrett’s center with the latest and best treatment options,“
said Harshit S. Khara, MD, FACG, FASGE, Clinical ­Associate Professor of Medicine,
Geisinger Medical Center.

SEVERE PAIN AT DAY 2

Ablation extending to the submucosa1
RFA
Combines deep
ablation with
a favorable 1. Louie B, et al, Evaluation of a Novel Swipe Cryoballoon
safety profile2 Ablation System in Bench, Porcine, and Human Esophagus
Models. Gastrointestinal Endoscopy, Volume 85, No. 5S,
5 30 35 40 45 50 AB513-AB514: 2017.

2. Schölvinck DW, et al, Balloon-Based Esophageal

Cryoablation with a Novel Focal Ablation Device:
Dose-Finding and Safety in Porcine and Human Models.
Diseases of the Esophagus,
2017 Nov 1;30(11):1-8.

Effective Endoscopic Treatment For

BE-Associated Neoplasia3

95%
Complete Eradication of Dysplasia

88%
Complete Eradication of Intestinal Metaplasia
3. Canto M, et al. Multifocal Nitrous Oxide Cryoballoon Ablation
With or Without EMR for Treatment of Neoplastic Barrett’s
Esophagus. Gastrointest Endosc. 2018 2018; 88: 438-446.
doi: 10.1016/j.gie.2018.03.024

Less Pain4

PATIENTS REPORTING SEVERE PAIN AT DAY 2

RFA

CryoBalloon

%0 5 10 15 20 25 30 35 40 45 50 4. Van Munster, et al, Post-Procedural Pain After Endoscopic

Ablation Therapy of Barrett’s Esophagus: Is Cryo Ablation
Less Painful Compared with Radiofrequency Ablation?,
Gastrointestinal Endoscopy.
2017 May; Volume 85, Issue 5, Supplement, Page AB568.

95%
Complete Eradication of Dysplasia
VENTITIA

88%
All in a Smart and Compact Design
Complete Eradication of Intestinal Metaplasia

C2 CryoBalloon™ Ablation System Provides:

• Targeted access delivered through the working channel of a

therapeutic endoscope
• An intuitive interface
• Smart, compact design that eliminates the need for large tanks
or capital equipment
 02-3 C2 CryoBalloon™Ablation System

C2 CryoBalloon™ Ablation System portfolio of products

Multiple CryoBalloon shapes and targeting options designed for various anatomic structures

Pear shaped catheter

Model Article Pack size Description

name number

Pear shaped catheter designed for

FG-1024 300617 1
Ablation of GEJ

Standard shaped catheter

Model Article Pack size Description

name number

FG-1028 300613 1 Standard shaped catheter for tubular esophagus

C2 CryoBalloon™ Ablation System controller and cartridges

Model Article Pack size Description

name number

FG-1017 300610 1 C2 CryoBalloon™ Ablation System Controller

FG-1013 300612 5 C2 CryoBalloon™ Ablation System Cartridge

C2 CryoBalloon™ Ablation System Foot Pedal

Model Article Pack size Description

name number

C2 CryoBalloon™ Ablation System Foot Pedal,

FG-1018 300611 1
enables rotational & axial targeting

Consult your local representative for information on the products currently available in your region.
Manufacturers

PENTAX Medical
Splash M-Knife HOYA Corporation TOP Endoscopic Hood TOP Corporation C2 CryoBaloon™ A Division of PENTAX of America, Inc.
Mucosectom 6-10-1, Nishi-shinjuku 19-10, Senju Nakai-cho Ablation 303, Convention Way, Suite 1
Ksnare Shinjuku-ku, Tokyo Adachi-ku, Tokyo System Redwood City, CA 94063
HemoStat WideCup 160-0023 Japan 120-0035 Japan USA

PENTAX Europe GmbH MPS Medical Product Service GmbH PENTAX Europe GmbH
Julius-Vosseler-Straße 104 Borngasse 20 Julius-Vosseler-Straße 104
22527 Hamburg, Germany 35619 Braunfels, Germany 22527 Hamburg, Germany

0123 0123 0197

TÜV SÜD CE 0123 Medical Device Class: IIb TÜV SÜD CE 0123 Medical Device Class: IIa TÜV Rheinland CE 0197 Medical Device Class: IIa

Distributor
LCM/01/08/21/320528/02 MKTH-2951EN-EMEA Rev 1

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]

This product must be used only by healthcare professionals.

Before usage and for detailed product specifications, please refer to the instructions for use. In the interest of technical process,
specifications may change without notice.
Product availability cannot be guaranteed in all countries. For further information please contact your local sales representative.