The ultraflex diamond stent is made of nitinol, a nickeltitanium alloy that provides a high degree of flexibility fig. The neuroform ez stent system is comprised of a selfexpanding nitinol stent, preloaded on an enhanced stent delivery wire. The applied length varies according to the length of the obstruction 1015 cm with a covered length of 712 cm. To present the complications of ultraflex selfexpandable metallic stents semss applied in patients with benign tracheobronchial diseases. Before opening the package, inspect the package for damage. The computational fluid dynamics method, which provides an estimation of the pressure drop in the airway before and after the stent implantation, is proposed in this study. In addition, severe pain and food obstruction were also only seen in patients treated with psems. The ultraflex esophageal stent system maintains luminal patency in esophageal strictures caused by intrinsic or extrinsic malignant tumors. For most patients stent insertion will be the quickest way of palliation as it avoids the need for referral and travel to tertiary centres. Factors to obstructive granulation tissue formation after ultraflex stenting in benign tracheal narrowing the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special. Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction. Ultraflex precision colonic stent placement for palliation. Evolution, sxella, hanarostent, nitis, ultraflex ng, and.
The first case presents an emergency indication for cardiopulmonary bypass in a life. Placement of the ultraflex tracheobronchial stent system is contraindicated in patients with strictures that cannot be dilated to at least 4 mm or cannot pass a. To the best of our knowledge, all previous studies used incidence proportions. How i do it catheterise oesophagus with angled catheter and. The proposed methodology was evaluated in seven health people control group and in fourteen patients who were.
Full text of fully covered selfexpandable metal stents. It is constructed as a laserwelded single knitted wire. Selfexpanding plastic stent to palliate symptomatic. Highly visible green sutures facilitate endoscopic visualization. View ordering information for ultraflex singleuse covered esophageal ng stent system distal release. In network a, when compared to the ultraflex stent, the polyflex stent increased the risk of stent migration 2.
All ultraflek spa products are designed and manufactured to ensure the best performance. Recurrent airway obstructions in a patient with benign tracheal stenosis and a silicone airway stent. Do not use if the package has been opened or damaged. The covered stent can also be used for occlusion of concurrent esophageal fistula. The appearance of a bronchopleural fistula is a wellknown and frightening complication of pulmonary surgery. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Healing of bronchopleural fistula using a modified dumon. Relapsing polychondritis treated with an ultraflex. In this case we used a modified y dumon stent in an attempt to close a bronchopleural fistula. The author also provides detailed product information, recommendations, and contraindications for the use of both stents. This site is not intended as a substitute for professional medical care. Despite removal of airway metallic stents by rigid bronchoscope was presented, there are few reports describing such removal by flexible bronchoscope. The latter includes the selfexpandable stent or classic dumon stent.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms. Complications recorded were lower respiratory tract infections, stent migration, granulation tissue, mucus plugging requiring intervention, tumor overgrowth, and stent fracture. The stent expansion results from the physical properties of the. The pressure field was solved by the navierstokes equations. The ultraflex is composed of a woven, single strand of nitinola nickeltitanium alloywith a unique shape memory property. Ruptured stent covers were only seen with ultraflex stents.
Baremetal colonic stent a sterile nonbioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. The highest rate of late complications was seen in patients treated with ultraflex stents. Radiological imageguided placement of covered nitis stent for palliation of dysphagia in patients with cervical esophageal cancer, dysphagia, 20, pp. The edges of the monofilaments are protected with silicone to avoid impaction andor tissue damage at the proximal and distal ends. We are reporting two cases which demonstrate the additional benefits of using cardiopulmonary bypass during difficult bronchoscopy and complex airway stenting. Only your physician can diagnose and appropriately treat your symptoms. The stent is completely covered with a biocompatible polyurethane membrane. Interventional bronchoscopy for benign tracheobronchial.
This stent has a proximal flare of 23 mm to ensure fixation at the proximal edge of the tumour. Study of pre and poststent implantation in the trachea. In the management of refractory benign strictures of the oesophagus, stent usage should be carefully. Ultraflex esophageal ng stent system boston scientific. Class 2 device recall ultraflex tracheobronchial stent system. The ultraflex tracheobronchial stent system is provided sterile in both covered and uncovered versions and is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Thus, an ultraflex stent can adapt well to the irregular con.
Pdf the airway stents restore patency in the face of luminal compromise from intrinsic andor. The knitted design allows the ultraflex to adapt well into. Inability to eat solids inability to drink fluids inability to swallow saliva occasional vomiting. Boston scientifics products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular. The placement of esophageal stents in different esophageal. Moreover, a potential cost benefit vs surgery has been shown. The interstices of the lattice work are larger compared to those of the wallstent. Duda2 1nitinol devices and components, fremont, ca usa 2dept of diagnostic radiology, university of tuebingen, tuebingen, germany summary over 100 different stent designs are currently being marketed or are in evaluation for vascular and nonvascular indications. A comparison of ultraflex diamond stents and wallstents for palliation of distal malignant biliary strictures article pdf available in the american journal of gastroenterology 953. Ultraflex metal stent to treat duodenal cancer ingrowth. Ultraflex nitinol stent with sutured loop ends was placed. Z stent cook medical requires manual loading of the.
Esophageal stenting in the setting of malignancy ncbi. Study of pre and poststent implantation in the trachea using computational fluid dynamics tzuching shih1,2,3 4 hungda hsiao,5 7 poyuen chen6 chihyen tu,8 tzui tseng5 yungjen ho1,2 1department of biomedical imaging and radiological science, china medical university taichung 404, taiwan, roc. Implantation of ultraflex nitinol stents in malignant. After the development of technique of stent placement in esopahgus, there was revolutionary change in the management of such conditions. Longterm followup of ultraflex metallic stents in benign and. Ultraflex tracheobronchial uncovered stent system boston. Covered and uncovered ultraflex stents are available to maintain esophageal luminal patency in esophageal strictures caused by malignant tumors only. Respiratory infections increase the risk of granulation. Stent migration occurred most frequently with fsems 20%, followed by seps 14% and psems 10%, while tissue in andor overgrowth was only seen with psems 11%. Longterm followup and survival after ultraflex stent insertion in the management of complex malignant airway stenoses. Endoscopic removal of an esophageal stent after diffuse. Ultraflex precision nitinol colorectal stent ultraflex precision nitinol colorectal stent references.
Dangas, md, phd even in the contemporary era of percutaneous coronary intervention using drugeluting stents, in stent restenosis isr remains a common problem, occurring in 5% to 20% of cases, depending on several. The primary goal of esophageal stent insertion in patients with. In the upper oesophagus, the covered ultraflex stent more flexible and less radial force is recommended, reducing the risk of pain associated with the use of the stiffer devices 5. This mortar has a high content of unique dry polymer, resulting in excellent adhesion to the substrate and tile. The ultraflex esophageal and diamond biliary stents. Ultraflex spa has been a leader in steering systems for pleasure and professional boats for many years. Factors to obstructive granulation tissue formation after. The ultraflex tracheobronchial stent system is provided sterile and is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Boston scientific, m00576490, boston scientific ultraflex. Grasping the knots over it with biopsy forceps also allows us to reposition the stent after deployment, like in our patient. Radiological imageguided placement of covered nitis. Do airway metallic stents for benign lesions confer too. The rate of tissue overgrowth was more higher with ultraflex stents, and to a.
Before stent insertion, 24% of the subjects were subjected to bougienage and. Ultraflex stent boston scientific, natick, ma, usa. The ultraflex stent was pushed into the gastric cavity. Numerical analysis of airflow alteration in central. In the past, the esophagus diseases causing the patient to unable to intake oral diet such as esophageal strictures, leaks, tracheoesophageal fistulas, etc. A survey of stent designs university of southampton. Ultraflex boston scientific, natick, ma, a tightly woven, selfexpandable metallic stent composed entirely of a single strand of nickeltitanium alloy, was the stent of choice for this study. In our group of patients we observed considerable differences in complications rates for different stents.
Oesophageal stent insertion for palliation of dysphagia in. In the current research paper, ultraflex stent was used for 48% of the patients, choosent was applied for 44% of the patients and the other types of stents were used for the remaining 8%. Z stents and ultraflex stents were implanted in 7 patients for between 1 to 1 months with no complications and showed stable effects. Tracheobronchial stent system device description the merit endotek aeromini tracheobronchial stent system is comprised of two components. The use of selfexpandable metal stents semss has had a large role in dysphagia. The neuroform ez stent system is authorized under a humanitarian device exemption hde. Stent and is engineered with outstanding flexibility, making it the only fully connected yet flexible selfexpanding stent. Striving to reduce the diameter of the stent, a polypectomy snare was used, but it was slipping over the stent. Insertion of selfexpandable metallic stent in an adult. Patients were excluded if more than one type of stent was in place at the same time. To our knowledge, this is the first patient who underwent insertion of ultraflex for the extrinsic bronchial compression of vascular origin in adulthood in the literature. Visually inspect the tracheobronchial stent system for any sign of damage. Recurrent airway obstructions in a patient with benign.
Enforcement report for september 8, 2010 michael medlin 10 boston scientific ultraflex uncovered tracheobronchial stent system proximal release 104 materialupncatalog number. Benign esophageal ruptures and anastomotic leaks are lifethreatening conditions that are often treated surgically. The principles of sems implanta tion in our institution under conscious sedation and local. Flex vascular stent system was inspired by the native vessel and designed to overcome the constant biomechanical challenges that stents face. The spot designed for increased radiopacity and radial stability new connector design for increased expansion diameter increased radial stability maintaining the same flexibility high stent deliverability low crossing profile 0. All patients received a stent with proximal release.
Palliative treatment with ultraflex precision stent. All 3 dumon stents were removed immediately due to migration. Ultraflex metal stent to treat duodenal cancer ingrowth into a wallflex stent. Longterm outcomes and complications of metallic stents for.
Remove airway ultraflex stents by flexible bronchoscope. The ultraflex tracheobronchial stent system is provided sterile in both covered and uncovered versions and is indicated for use in the treatment of tracheobronchial strictures produced by. Pdf the use of selfexpandable metallic stents in the airways in. To assess the uncovered ultraflex nitinol stent boston scientific. Stents in the proximal esophagus gastrointestinal endoscopy. Stent migration in one patient was related to undersizing of the stent diameter relative to the airway diameter. The material properties unique to the ultraflex esophageal stent and the diamond biliary stent along with their clinical benefits are presented in detail. Different methods have been used to solve this problem conservatively, from bronchial gluing to stent placement. Class 2 device recall ultraflex uncovered esophageal stent. The use of cardiopulmonary bypass as an adjunct to airway surgery for nonmalignant diseases in adults is not well established in the uk. The polyflex stent boston scientific is a polyester mesh stent completely covered by a silicone layer with a smooth inner surface and a structured outer surface. Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option.
There is a valuable role to avoid surgery in patients with metastases, and the need for temporary or permanent stoma1. The use of selfexpanding metallic stents semas in the treatment benign airway obstruction is controversial. Thanks to the proven polymerfree matrix coating, it provides continuous and controlled drug delivery. Ultraflex tracheobronchial stent system boston scientific. Posizionamento di protesi ultraflex in paziente con neoplasia. The ultraflex tracheobronchial stent system is provided sterile in both covered and uncovered versions and is indicated for use in the treatment of. Thirty patients with malignant esophageal stenosis underwent ultraflex esophageal stent deployment and were followed up for a maximum of 29 months from. Using flexible bronchoscopy, 82 semas 67% ultraflex, 33% wallstent were placed in 35 patients with inoperable lesions, many with. Complications of airway selfexpandable metallic stent in. A larger diameter relative stent was subsequently inserted successfully. Investigating esophageal stentplacement outcomes in. R stent is useful in rp, but remains controversial for in longterm management.
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