Novatech Products for
Novatech and Boston Medical Products Bringing you the finest products for Novatech is a manufacturer of top-quality medical products used successfully worldwide in the growing specialty of. 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. Manufactured by Exclusive U.S. Distributor Page 2
Content DUMON Tracheobronchial silicone stents, Tracheal Stent...7, Thin Tracheal Stent...8 DUMON ST, Hourglass Stent...9, Bronchial Stent... 10 DUMON Y, Bifurcation Stent... 11 Instruments TONN NOVATECH Tracheal and Bronchial Stent Applicator...12 13 DUTAU Forceps... 14 SURVAC Suction Catheters... 15 NOVATECH is a registered trademark of Novatech SA in the USA, Europe, and other countries. DUMON is a trademark of Novatech SA. Page 3
Tracheobronchial Silicone Stents Novatech DUMON Products for DUMON ST DUMON Y DUMON Renowned for decades Since 1989, Novatech has been manufacturing the patented DUMON silicone stent a stent system that has been tried-and-tested to improve patient comfort. DUMON stents are made of specially treated medical grade transparent or radiopaque silicone (implantable for more than 29 days). They are considered the golden standard to which all others should be compared 1. 1 Bolliger, Pulmonary Reviews, Oct. 1997 Indications Maintaining airway patency after desobstruction or dilation of a stenosis, in particular in the following cases: tracheobronchial tumors tracheobronchial stenoses with scarring tracheobronchial stenoses after anastomosis, resection or lung transplantation diameter reduction from intraluminal, extraluminal and intramural changes Page 4
Features Large collection for perfect adaption The key condition for perfect tolerance of the stents is to use a stent which is perfectly adapted to the patient s needs. For this reason and in order to be prepared for any situation, it is essential to provide the physician with a basic line of different stent types, diameters and lengths. The stents must not be cut in order to avoid the risk of granulation and to ensure transport of secretion (please refer to the Instructions for Use). Anti-migration stud system Depending on the design, there are 2, 3 or 4 lines of studs on the stent outside. The stud design minimizes the risk of migration of the stent by fixing it between the cartilaginous rings of the tracheo-bronchial tree. The stent design inhibits cough reflexes. The studs reduce direct contact between the stent surface and the mucosa and distribute compressive forces evenly among the small stud surfaces. Non-adherent smooth surface The stent inside is treated with a silicone-based layer which makes the surface anti-adherent, minimizing the risk of obstructions and improving the transport of secretion. The stent surface is excellently tolerated by the mucosa. Bevelled ends The ends of the stents are designed to reduce the risk of mucus accumulation. They are specially bevelled to be atraumatic and to improve the transport of secretion. Unrestricted implant-grade silicone (over 29 days) Easy placement The stents can be placed easily with the TONN NOVATECH stent applicator via rigid bronchoscopy. Easy removal The stents can be removed easily by grasping them with rigid forceps and pulling them into a rigid bronchoscope. NOVATECH and LOT imprinted on transparent stents with a diameter of 10 mm or larger Specially bevelled ends Page 5
DUMON The different types of stents Designation Type Wall Thickness (mm) Rows of Studs Tracheal Stent 1.5 4 Thin Tracheal Stent 1.0 DUMON ST Hourglass Stent particularly for post-intubation stenoses 4 ( = 20 mm: 3) 1.5 4 Bronchial Stent 1.0 4 DUMON Y Bifurcation Stent 1.0 3 The above mentioned stents are available as standard stents, in a large variety of sizes (see chart below). Other sizes and types are available as custom made stents. Stent Size Guide DUMON TD / DUMON TF / DUMON BD Determine the stent length (length of stenosis + 10 mm) and the stent diameter to choose from the available stents. Length (mm) g OD (mm) i 20 30 40 50 60 70 80 90 100 110 9 10 11 12 13 14 15 16 18 20 This chart comprises only straight stents. For sizes of DUMON Y and DUMON ST, please refer to the respective catalog page. Page 6
Tracheal Stents are Novatech s standard endotracheal stents, with a wall thickness of 1.5 mm. Features Available in either transparent or radiopaque Non-adherent smooth surface Anti-migration stud system Bevelled ends Removability Unrestricted implant-grade silicone TD stent in situ transparent Length (mm) g OD (mm) i 20 30 40 50 60 70 80 90 100 110 11 03001 03021 03041 03061 03081 03101 12 03121 03141 03161 03181 03201 03221 03231 13 03261 03281 03301 03321 03341 14 03381 03401 03421 03441 03461 15 03531 03541 03551 03561 03571 03581 03591 03491 03501 16 03621 03641 03661 03681 03701 04281 04291 04301 04311 18 04121 04141 04151 Custom made stents available. Please contact customer service. radiopaque Length (mm) g OD (mm) i 20 30 40 50 60 70 80 90 100 110 11 03001R 03021R 03041R 03061R 03081R 03101R 12 03121R 03141R 03161R 03181R 03201R 03221R 03231R 13 03261R 03281R 03301R 03321R 03341R 14 03381R 03401R 03421R 03441R 03461R 15 03521R 03531R 03541R 03551R 03561R 03571R 03581R 03591R 03491R 03501R 16 03621R 03641R 03661R 03681R 03701R 04281R 04291R 04301R 04311R 18 04121R 04141R 04151R Custom made stents available. Please contact customer service. Page 7
Thin Tracheal Stents Endotracheal stents have a wall thickness of only 1.0 mm, which makes larger stent-diameters possible. Enhanced respiratory flow The larger inner diameter of a stent significantly enhances respiratory flow. For a standard tracheal stent of 50 mm in length and 16 mm in external diameter, the inner diameter increases by approx. 6 %, resulting in an increase of the luminal volume of 16 %. Improved transport of secretion The thinner walls of stents facilitate the internal movements of the trachea (respiration, ease of the peristaltic movements of the esophagus). This dynamic stent concept allows better transport of secretion (depending on mucus viscosity). Features Available in either transparent or radiopaque Non-adherent smooth surface Anti-migration stud system Bevelled ends Removability Unrestricted implant-grade silicone transparent Length (mm) g OD (mm) i 30 40 50 60 70 80 90 100 110 12 03141F 03161F 13 03261F 03281F 03301F 03321F 03341F 14 03381F 03401F 03421F 03441F 03461F 16 03641F 03661F 03681F 03701F 04281F 04291F 04301F 18 04141F 04151F 04161F 04171F 04181F 04191F 04201F 20 04231F 04241F 04251F 04261F 04271F 04431F 04441F 04451F Custom made stents available. Please contact customer service. radiopaque Length (mm) g OD (mm) i 30 40 50 60 70 80 90 100 110 13 03261FR 03281FR 03301FR 03321FR 03341FR 14 03381FR 03401FR 03421FR 03441FR 03461FR 16 03641FR 03661FR 03681FR 03701FR 04281FR 04291FR 04301FR 20 04241FR 04451FR Custom made stents available. Please contact customer service. Page 8
DUMON ST Hourglass Stents DUMON ST were designed in collaboration with Prof. Vergnon (Saint Etienne University Hospital, France). They are especially adapted to complex benign stenoses post intubation stenoses post tracheostomy stenoses subglottic stenoses. DUMON ST Easy to place after laser resection or dilatation, this stent is designed to avoid the risk of migration inherent to compression reduction. No migration was observed in a study covering a follow-up period of two years. With a mean dwell time of 19.6 months, even a curative effect has been observed in 4 of 13 patients. 1 The diameters of the distal and proximal ends correspond to the size of the healthy trachea. The central part is narrower, reducing the risk of traumatizing the stenotic part of the trachea while maintaining a sufficient lumen for the airflow and thus reducing the risk of restenosis. The ST was developed in cooperation with Prof. Vergnon, France, especially for treatment of benign tracheal stenosis such as post-intubation stenosis in the proximal part of the trachea. In some cases, placement of an ST-Stent can help prevent a tracheostomy. 2 Features Available in either transparent or radiopaque Non-adherent smooth surface Anti-migration stud system Bevelled ends Removability Unrestricted implant-grade silicone L 1 OD 1 1 Pr Jean-Michel Vergnon, CHEST 2000; 118:422-426 2 Pr Jean-Michel Vergnon, Efficacy and Tolerance of a New Silicone Stent for the Treatment of Benign Tracheal Stenosis. CHEST 2000 L 2 OD 2 L 3 OD 3 DUMON ST transparent DUMON ST radiopaque Dimensions (mm) REF OD Lengths Wall 1 2 3 L1 L2 L3 Thickness 09041 12 10 12 09031 14 12 14 09051 15 13 15 15 20 15 1.5 09011 16 14 16 09061 18 16 18 Custom made stents available. Please contact customer service. Dimensions (mm) REF OD Lengths Wall 1 2 3 L1 L2 L3 Thickness 09041R 12 10 12 09031R 14 12 14 09051R 15 13 15 15 20 15 1.5 09011R 16 14 16 09061R 18 16 18 Custom made stents available. Please contact customer service. Page 9
Bronchial Stents stents have been developed for bronchial indications. The stent design corresponds to the smaller bronchi diameters and ensures optimal ventilation of the patient. Improved transport of secretion The 1.0 mm thin walls of stents facilitate the internal move ments of the trachea (respiration, ease of the peristaltic movements of the esophagus). This dynamic stent concept allows better transport of secretion (depending on mucus viscosity). Stent in situ Features Available in either transparent or radiopaque Non-adherent smooth surface Anti-migration stud system Bevelled ends Removability Unrestricted implant-grade silicone transparent Length (mm) g OD (mm) i 20 30 40 50 60 70 9 02841 04341 04371 04391 04411 04421 10 03721 03741 03761 03781 03801 03821 11 03841 03861 03881 03901 03921 12 03961 03981 04001 04021 04041 04051 Custom made stents available. Please contact customer service. radiopaque Length (mm) g OD (mm) i 20 30 40 50 60 70 9 02841R 04341R 04371R 04391R 04411R 04421R 10 03721R 03741R 03761R 03781R 03801R 03821R 11 03841R 03861R 03881R 03901R 03921R 12 03961R 03981R 04001R 04021R 04041R 04051R Custom made stents available. Please contact customer service. Page 10
DUMON Y Bifurcation Stents DUMON Y stents have 3 rows of studs. The posterior side has no studs in order to avoid trauma of the tracheo-esophageal wall. The branches are angled according to anatomy. Custom lengths and diameters are available on request. DUMON Y stents may be modified by Novatech in order to allow airflow to the right upper lobe. DUMON Y A closed right branch stem for pneumonectomized patients with a fistula is available on a custom basis. outer diameter 1 L1 Features Available in transparent only Reduced pressure to the posterior tracheal mucosa Easy placement with TONN NOVATECH stent applicator Anti-migration stud system Non-adherent smooth surface Bevelled ends Removability Unrestricted implant-grade silicone L2 L3 outer diameter 2 30 45 outer diameter 3 DUMON Y transparent REF Dimensions (mm) OD Lengths Wall 1 2 3 L1 L2 L3 Thickness 91011 14 10 10 110 50 50 92011 15 12 12 110 50 50 93011 16 13 13 110 50 50 94011 18 14 14 110 50 50 Custom made stents available. Please contact customer service. 1.0 Page 11
TONN NOVATECH Tracheal and Bronchial Stent Applicator basic block pusher clamping rod folding device loading rod introducer tube Developed by Dr. Tonn (Hanover, Germany), the TONN NOVATECH tracheal and bronchial Stent Applicator facilitates the placement of Novatech s tracheobronchial DUMON stents through a rigid bronchoscope. Easy to handle, the TONN NOVATECH Stent Applicator is available in four sizes (BLUE, RED, GREEN and WHITE) allowing the insertion of silicone stents in a wide range of sizes: Stents with an outer diameter of up to 20 mm and a length of up to 160 mm (Y-Stents) can be placed. Furthermore Y-Stent insertion is facilitated. The correct position of the branches for the left and the right bronchus is determined before insertion, minimizing the risk of misplacement and stent damage. Page 12
TONN NOVATECH Tracheal and Bronchial Stent Applicator Color Introducer tube length (cm) Introducer tube OD (mm) BLUE 32 12.75 02 BRS B 120 RED 42 12.75 02 BRS R 130 GREEN 42 10.25 02 BRS G 140 WHITE 42 8.2 02 BRS W 150 Individual components available as spare parts. Please contact us for a quotation. REF Which applicator (BLUE, RED, GREEN, WHITE) is used for which DUMON stent? TD Length 20 30 40 50 60 70 80 90 100 110 11 P P P P P P P 12 P P P P P P P 13 P P P P P P 14 P P P P P P 15 P P P P P P P P P P 16 P P P P P P P P P P 18 P P P TF Length 30 40 50 60 70 80 90 100 110 12 P P 13 P P P P P 14 P P P P P 16 P P P P P P P 18 P P P P P P P 20 P P P P P P P P BD Length 20 30 40 50 60 70 9 P P P P P P 10 P P P P P P 11 P P P P P 12 P P P P P P ST 12 P 14 P 15 P 16 P 18 P Y 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 13
DUTAU Forceps The DUTAU Forceps allows the physician to create a smooth fenestration in a NOVATECH DUMON silicone stent in order to adapt it to a specific situation (e.g. ventilation of the upper lobe). DUTAU Forceps REF Description Items per box 6522 DUTAU Forceps 1 Page 14
SURVAC Suction Catheters for bronchoscopy SURVAC are atraumatically rounded single use suction catheters for bronchoscopy. The PTFE-catheters are more flexible than the polycarbonate (PC) catheters. Due to their flexibility and their small diameter, the PT- FE-catheters are adapted to suctioning more distal parts of the tracheobronchial tree. The larger (3 4 mm) polycarbonate catheters are particularly suited for the axial aspiration of larger tumor parts or suctioning of large quantities in emergency cases. REF Description Diameter (mm) ID OD Length (cm) 77622 SURVAC PTFE 2.0 3.0 60 77632 SURVAC PC 2.0 2.7 60 77642 SURVAC PC 3.0 4.0 60 77642SC SURVAC PC 3.0 4.0 30 Connector Items per box female, PVC 50 Page 15
Manufactured by Exclusive U.S. Distributor To Place an Order 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.) Main Telephone: 508-898-9300 24-hour-Fax: 508-898-2373 Prescription Policy U.S. federal law restricts these products to sale by or on the order of a physician. Shipment 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. Warranty 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. 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. BMP-PCA-NOV-3.0 2018-05 Boston Medical Products, Inc. 70 Chestnut Street Shrewsbury, MA 01545 USA Tel. +1 (508) 898-9300 Fax +1 (508) 898-2373 info@bosmed.com