Catalog - Boston Medical Products Inc.

NOVATECH
PRODUCTS FOR INTERVENTIONAL PULMONOLOGY
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
NOVATECH and Boston Medical Products
Bringing you the finest products for Interventional Pulmonology
NOVATECH is a manufacturer of top-quality medical products used successfully worldwide in the
growing specialty of Interventional Pulmonology. Their original product, the DUMON™ Silicone Stent,
has been helping treat patients since 1989, and continues to be the Gold Standard to which all
other stents are compared. Boston Medical Products has been manufacturing specialized medical
devices for head, neck, and tracheostomy applications since 1980.
Boston Medical Products is the proud exclusive U.S. Distributor of NOVATECH products.
This catalog features the flagship DUMON™ Silicone Stents, the largest range of models and sizes in
the world, along with the TONN™/NOVATECH Stent Applicator System.
NOVATECH and Boston Medical Products share a common vision - to develop tailored medical
devices to give patients a better quality of life. To this end, we are in constant communication
with physicians, nurses, healthcare professionals, and patients themselves, striving to improve our
existing products and to develop new products. We are aware of the need for individual solutions,
so please contact us if you need special customization of our existing designs.
For additional information and to see other exciting products from NOVATECH and Boston Medical
Products, please visit www.novatech.fr and www.bosmed.com.
Manufactured by:
page 2
Exclusive U.S. Distributor:
www.bosmed.com
www.novatech.fr
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
DUMON™ Tracheal and Bronchial Stents
DUMON™ - The Original Silicone Stent
The DUMON™ Stent is the original patented design,
used successfully worldwide to treat tracheal and
bronchial obstructions and stenoses. The stents are
made from implant-grade silicone suitable for longterm placement and the only appropriate stent
material for benign disease. The stents feature
an exclusive surface treatment to ensure nonadherence and to improve mucociliary clearance.
The material is flexible enough to allow for
atraumatic insertion and placement, yet will seek
its original shape following placement, providing
the force necessary to correct compressions of the
trachea and bronchus.
Depending on design, there are two, three or
four rows of studs on the outside of the stent.
This patented stud design aids in preventing
migration by naturally fixing the stent between
the cartilaginous rings of the trachea or bronchus
while minimizing unnecessary contact between the
stent and mucosal surfaces. This design distributes
compression forces evenly. It is important to select
the appropriate diameter stent to minimize any
chance of migration.
DUMON™ Stents are available in the following models:
Type
Rows of
Studs
Wall
Thickness
(mm)
4
1.0
4
1.5
4
(Ø ≥ 18 mm: 3)
1.0
BD
Straight Bronchial Stent
TD
Straight Tracheal Stent
TF
Straight Tracheal Stent
BB
Pediatric Stent
2
0.5
ST
Hourglass Stent
4
1.5
CB
Bronchial Stent
4
1.0
Y
Y Stent
3
1.0
(Ø ≥ 18 mm: 3)
The ends of the stents are straight and specially
beveled to maximize airflow while helping to
prevent crusting and granulation tissue formation.
Animations illustrating the placement of
DUMON™ stents are available. Please visit
www.bosmed.com
Dutau® Forceps REF 6522
Allows the physician to create a smooth
fenestration in DUMON™ silicone stents
in order to adapt to a specific situation
(e.g. ventilation of the upper lobe).
www.bosmed.com
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page 3
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
DUMON™ BD Bronchial Stent – 1.0 mm wall thickness
Dimensions below = outside diameter (mm) x length (mm)
02841 9
Product02841
04341 9
Codes04341
/ REF: 04371
043719
04391
043919
044119
04411
044219
04421
x9 20
x 20
x9 30
x 30
x9 40
x 40
x9 50
x 50
x 60
x9 60
x 70
x9 70
03721
03841
0372110
10 xx 20
20
0384111
11xx20
20
03741
03861
0374110
10 xx 30
30
0386111
11xx30
30
03761
0376110
10 xx 40
40
03881
0388111
11xx40
40
03781
0378110
10 xx 50
50
03901
0390111
11xx50
50
0380110
10 xx 60
60
0392111
11xx60
60
03801
03921
0382110
10 xx 70
70
03821
03961 12 x 20
03981
12 12
x 30
03961
x 20
04001
12 12
x 40
03981
x 30
04021
04001
12 12
x 50
x 40
04041
04021
12 12
x 60
x 50
04041
x 60
04051
12 12
x 70
04051 12 x 70
Supplied non-sterile.
Radiopaque Stents: Add “R” at end of product code (i.e. 02841R = BD 9 x 20 Radiopaque)
DUMON™ TD Tracheal Stent – 1.5 mm wall thickness
Dimensions below = outside diameter (mm) x length (mm)
DUMON™ TD and
DUMON™ TF
Product03001
03001 11 x 20
20
03021 11 x 30
30
Codes03021
40
/ REF: 03041
03041 11 x 40
03061 11 x 50
50
03061
03081
03081 11 x 60
60
03101
03101 11 x 70
70
03121
03121 12 x 20
20
03141
30
03141 12 x 30
03161
40
03161 12 x 40
03181
03181 12 x 50
50
03201
03201 12 x 60
60
03221
03221 12 x 70
70
03231
03231 12 x 80
80
03261 13 x 30
30
03261
03281
03281
03301
03301
03321
03321
03341
03341
03381
03381
03401
03401
03421
03421
03441
03441
03461
03461
03521
03531
03531
03541
03541
03551
03551
03561
03561
03571
13 x 40
40
50
13 x 50
60
13 x 60
70
13 x 70
14 x 30
30
14 x 40
40
14 x 50
50
60
14 x 60
70
14 x 70
15 x 30
20
15 x 40
30
15 x 50
40
15 x 60
50
60
15 x 70
03581
03571 15 x 70
80
03581 15 x 80
03591
90
03591 15
15xx100
90
03491
03491 15
15xx110
100
03501
03621
03501 15
16 x 110
30
03641
03621 16 x 30
40
03661
03641 16 x 40
50
03661 16 x 50
03681
60
03681 16 x 60
03701
70
04281
03701 16 x 70
80
04291
04281 16 x 80
90
04301
04291 16
16xx100
90
04311
04301 16
16xx110
100
04311 16
04131
18 x 110
30
04121
04141 18
18 xx 20
40
04141
04151 18
18 xx 40
50
04151
04161 18
18 xx 50
60
04161
04171 18
18 xx 60
70
04171
04181 18
18 xx 70
80
04181
04191 18
18 xx 80
90
04191
04201 18
18xx100
90
04201
18xx110
100
04211 18
04211
04215 18
20 xx 110
30
04231
04231 20
20 xx 40
40
04241
04241 20
20 xx 50
50
04251
04251 20
20 xx 60
60
04261
04261 20
20 xx 70
70
04271
04271 20
20 xx 80
80
Supplied non-sterile.
Radiopaque Stents: Add “R” at end of product code (i.e. 03021R = TD 11 x 30 Radiopaque)
DUMON™ TF Tracheal Stent – 1.0 mm wall thickness
Dimensions below = outside diameter (mm) x length (mm)
DUMON™ TD and
DUMON™ TF
Product03141F
03141F 12 12
x 30
x 30 03641F
03381F
16 14
x 40
x 30
Codes03161F
03161F 12 12
x 40
x 40 03661F
03401F
16 14
x 50
x 40
/ REF: 03261F
03261F
13 13
x 30
x 30 03681F
03421F
16 14
x 60
x 50
03281F
13 13
x 40
16 14
x 70
03281F
x 40 03701F
03441F
x 60
03301F
03301F
13 13
x 50
x 50 04281F
03461F
16 14
x 80
x 70
03321F
03321F
13 13
x 60
x 60
04291F 16 x 90
03341F
03341F
13 13
x 70
x 70
04301F 16 x 100
03381F 14 x 30
04141F 18 x 40
03401F 14 x 40
04151F 18 x 50
03421F 14 x 50
04161F 18 x 60
03441F 14 x 60
04171F 18 x 70
03461F 14 x 70
04181F 18 x 80
04191F
03641F1816x x9040
04201F
03661F1816x x100
50
04211F
03681F1816x x110
60
04231F
03701F2016x x4070
04241F
04281F2016x x5080
04251F
04291F2016x x6090
04261F
04301F2016x x70100
04271F 20 x 80
04431F 20 x 90
04441F 20 x 100
04451F 20 x 110
04171F
04241F
04261F
04271F
04441F
04451F
Supplied non-sterile.
Radiopaque Stents: Add “R” to product code (i.e. 03141FR = TF 12 x 30 Radiopaque)
page 4
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18 x 70
20 x 50
20 x 70
20 x 80
20 x 100
20 x 110
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
DUMON™ BB Pediatric Stent
Initially developed for pediatric indications, DUMON™ BB have a wall thickness of only 0.5 mm.
The ratio between inner and outer diameter offers an excellent compromise between
reduced wall-thickness and resistance to compression. Stent placement is possible with
either a rigid scope or, for distal stenoses in adults, with a flexible bronchoscope.
Pediatric Indications
For pediatric indications, a rigid bronchoscopy must be performed for safety reasons. There
is no debate between surgery and stenting as surgery must be the first choice to solve a
problem. In some cases stenting can be a good temporary alternative.1)
Like all DUMON™ stents, the BB stent is made of implant grade silicone. It is highly
biocompatible and removal of the stent is possible any time.
DUMON™ BB are available in multiple lengths in order to both cover the stenosis and anchor
the stent. The controlled wall thickness aids in avoiding obstruction. In case of necessity,
the stent can be removed with foreign body forceps.
Adult Indications
For adult indications, placement is performed by flexible bronchoscope. Adult indications are
rare and must be considered as an exception, when stenting must secure lobar ventilation.
Patient quality of life is a key issue when determining the necessity of stenting.
Dimensions below = outside diameter (mm) x length (mm)
Product025301 5 x 50
Codes / REF: 026201 6 x 50
026501 7 x 50
026701 8 x 50
026751 9 x 80
026501 10 x 80
Supplied non-sterile.
Radiopaque Stents: Add “R” at end of product code (i.e. 025301R = 5 x 50 Radiopaque)
1)
FAYON, M. et al: French experience of silicone tracheo-bronchial
stenting in children. Pediatr Pulmonol. 2005, 39: 21-27
www.bosmed.com
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page 5
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
DUMON™ ST Hourglass Stent – 1.5 mm wall thickness
The DUMON™ ST Stent is an hourglass-shaped stent used successfully worldwide to treat postintubation stenosis and complex tracheal stenoses combining internal & external compressions,
as well as postoperative stenosis and cases of tracheal tumor. The silicone material is flexible
enough to allow for atraumatic insertion and placement, yet will seek its original shape
following placement, providing the force necessary to correct complex compressions of the
trachea.
The DUMON™ ST series features a wall thickness of 1.5 mm, maximizing airflow and mucociliary
clearance, and is available in both clear and radiopaque silicone.
Dimensions below = outside diameters (mm) x lengths (mm) of top, middle, and lower
portions
(i.e. 12-10-12 x 15-20-15 = top portion 12 mm o.d. and length of 15 mm; middle portion 10 mm
o.d. and length of 20 mm; lower portion 12 mm o.d. and length of 15 mm)
Product
Codes / REF:
09041
09031
09051
09011
09061
12-10-12
14-12-14
15-13-15
16-14-16
18-16-18
x
x
x
x
x
15-20-15
15-20-15
15-20-15
15-20-15
15-20-15
Supplied non-sterile.
Radiopaque Stents: Add “R” at end of product code (i.e. 09041R = 12-10-12 x 15-20-15
Radiopaque)
Custom diameters and lengths may be ordered.
DUMON™ CB Carina Bronchus Stent - 1.0 mm wall thickness
DUMON™ CB Stents feature­­ the original bronchial stent design with an angled flange for
compression of main stem bronchi. These stents are specifically designed for the carina, one of
the most difficult locations to manage obstructions. They are made from implant-grade silicone
suitable for long-term placement and the only appropriate stent material for benign disease.
The stent features an exclusive surface treatment to ensure non-adherence. The material is
flexible enough to allow for atraumatic insertion and placement yet will seek its original shape
following placement, providing the force necessary to correct compressions of the bronchus,
and, in particular, the carina. The CB is available in both clear and radiopaque silicone.
Dimensions below = outside diameter (mm) x length (mm)
Product
Codes / REF:
05881
05901
05921
05941
06001
06021
06041
06061
9 x 20
9 x 30
9 x 40
9 x 50
10 x 20
10 x 30
10 x 40
10 x 50
06121
06141
06161
06181
06241
06261
06281
06301
11
11
11
11
12
12
12
12
x
x
x
x
x
x
x
x
20
30
40
50
20
30
40
50
Supplied non-sterile.
Radiopaque Stents: Add “R” at end of product code (i.e. 05881R = 9 x 20 Radiopaque)
page 6
www.bosmed.com
www.novatech.fr
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
DUMON™ Y Stent 1.0 mm wall thickness
The DUMON™ Y Stent is the original patented design, used successfully worldwide
to treat compression of the trachea, carina, and proximal bronchi. Additionally,
with a closed right branch, the Y stent can be used to treat pneumonectomized
patients with fistulas. The stents are made from implant-grade silicone suitable
for long-term placement and the only appropriate stent material for benign
disease. The stent features an exclusive surface treatment to ensure nonadherence. The material is flexible enough to allow for atraumatic insertion and
placement, yet will seek its original shape following placement, providing the
force necessary to correct compressions of the trachea, carina, and proximal
bronchi.
Dumon Y-Stents have 3 rows of studs. The posterior side has no studs in order
to avoid trauma to the tracheo-esophageal wall. The patented stud design aids
in preventing migration by naturally fixing the stent between the cartilaginous
rings of the trachea while the lower “Y” shape prevents distal migration,
minimizing unnecessary contact between the stent and mucosal surfaces. The
ends are specially beveled to maximize airflow while helping to prevent crusting
and granulation tissue formation. Additionally, custom-made stents with oblique
bronchial ends are available.
The DUMON™ Y Stents are available in clear silicone.
Indications For Use:
• Tracheobronchial tumors
• Tracheobronchial stenosis with scarring
• Tracheobronchial stenosis following resection and anastomosis
• Tracheobronchial stenosis following pulmonary transplantation
Dimensions below = outside diameters (mm) x lengths (mm)
(i.e. 14-10-10 x 110-50-50 = tracheal portion 14 mm o.d. and length of
110 mm; bronchial ends 10 mm o.d. and lengths of 50 mm)
outer diameter 1
Product Codes / REF:
L1
L2
L3
outer
diameter 3
outer
diameter 2
091011
09101
092011
09201
093011
09301
094011
09401
09000SC
14-10-10 x 110-50-50
14-10-10 x Custom Lengths (specify)
15-12-12 x 110-50-50
15-12-12 x Custom Lengths (specify)
16-13-13 x 110-50-50
16-13-13 x Custom Lengths (specify)
18-14-14 x 110-50-50
18-14-14 x Custom Lengths (specify)
Custom Diameters and Lengths (specify)
Custom lengths and diameters may be ordered.
Also available on a custom basis is a closed right
branch stem for pneumonectomized patients
with a fistula. Custom stents with bronchial ends
cut at an angle may also be ordered.
Please call Customer Service for ordering
information.
www.bosmed.com
www.novatech.fr
page 7
NOVATECH
P RO DU C T S FOR IN TE RV E N TIONAL PULMONOLOGY
TONN™/NOVATECH STENT APPLICATOR SYSTEM
basic block
pusher
clamping rod
folding device
loading rod
introducer tube
The new TONN™/NOVATECH Stent Applicator is a complete
system for loading and deploying DUMON™ Stents,
including “Y” models, through a rigid bronchoscope.
Easy to use, the TONN™/NOVATECH Stent Applicator is
available in four sizes, allowing the insertion of silicone
stents in a wide range of sizes, including large-diameter
Y Stents.
page 8
Introducer Tube
Length
(cm)
Introducer Tube
ID (mm)
BLUE
32
12.75
02BRSB120
RED
42
12.75
02BRSR130
GREEN
42
10.25
02BRSG140
WHITE
42
8.2
02BRSW150
REF
www.bosmed.com
www.novatech.fr
NOVATECH
P RO D UC T S FOR IN TE RVE N TIONAL PULMONOLOGY
TONN™/NOVATECH STENT APPLICATOR SYSTEM
Easy Steps for accurate deployment of DUMON™ Stents:
Spray lubricant on stent
and folding system.
Insert introducer
into folding system.
Position stent and
lock in rod.
Close folding
system.
Insert loading rod in opposite
end of folding system
to load stent
into introducer.
Remove rod.
Stent is now loaded
and ready for
deployment through rigid
bronchoscope.
Deployment
of stent.
TONN™ System Contains one each of the following:
Basic Block
Folding System
Clamping Rod
Introducer
Loading Rod
Pusher
Silicone Spray Lubricant
Silicone Spray Lubricant
Product Code / REF: 68226
www.bosmed.com
www.novatech.fr
page 9
NOVATECH
P RO DU C T S FOR IN TE RV E N TIONAL PULMONOLOGY
Which applicator (white, green, red, blue) is used for which stent?
TF
Length
20 30 40 50 60 70 80 90 100 110
Diameter
12
13
14
15
16
18
PPP
PPP
PP
PP
PPP
PPP
PPP
BD
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
PPPP
PPPP
12
Diameter
11
11
12
P
P
P
P
P
P
P
P
P
P
P
P
PP
PP
P
PPP
6
7
8
9
10
11
12
Y
16
18
P
P
P
P
P
PPP
PPPP
PPPP
ST
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
12
P
P
P
P
P
P
P
P
14
15
16
18
CB
50/30/30
P
P
P
P
P
Length
20 30 40 50 60
P
P
P
P
Diameter
Diameter
15
P
P
P
P
P
P
P
P
P
P
Length
Length
110/50/50 40/30/30
14
16
PPPP
PPPP
PPPP
PPP
PPP
PPP
10 20 30 40 50
5
Diameter
Diameter
10
P
P
P
P
14
20
20 30 40 50 60 70 80
9
13
18
BB
Length
Length
30 40 50 60 70 80 90 100 110
Diameter
TD
9
10
11
12
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
PP
NB : Stents which can be placed with the BLUE system can also be placed with the RED system. For stents
not appearing in the chart and/or for custom made stents, please contact our customer service.
page 10
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page 11
Manufactured by:
Exclusive U.S. Distributor:
To Place an Order
Warranty
Our Customer Service Representatives are available from
8:30 a.m. to 5:00 p.m. (EST) Monday through Friday. Orders
can also be placed through our 24-hour fax line.
• Customer Service: 800-433-2674
(toll-free in the U.S. and Canada)
• Main Telephone: 508-898-9300
• 24-hour-Fax: 508-898-2373
Boston Medical Products, Inc. warrants that reasonable
care has been used in the manufacturing of all products. All
products are warranted to be free of defects at the time of
shipment. For specific product warranties, please refer to
individual product instructions for use.
Shipment
MK-NOVA-13A — 2013-10
• Standard shipping within the U.S. is FedEx two-day
delivery.
• Express orders are accepted until 3:00 p.m. (EST) for
next business day delivery nationwide.
• Most orders are shipped the same day.
• Saturday delivery is available in many areas.
Return Policy
Boston Medical Products, Inc. will accept returned items
that are unopened in the original packaging.
• Please call Customer Service to obtain a Return
Authorization.
• Returns accepted within 30 days from invoice date.
• A Return Authorization is required for all returns.
• All returns are subject to a restocking fee.
• Merchandise credit only.
Exclusive U.S. Distributor:
Boston Medical Products, Inc.
117 Flanders Road, Westborough, MA 01581 USA
T: 508.898.9300 • F: 508.898.2373
www.bosmed.com • [email protected]