The proposed methodology was evaluated in seven health people control group and in fourteen patients who were. To assess the uncovered ultraflex nitinol stent boston scientific. Striving to reduce the diameter of the stent, a polypectomy snare was used, but it was slipping over the stent. Enforcement report for september 8, 2010 michael medlin 10 boston scientific ultraflex uncovered tracheobronchial stent system proximal release 104 materialupncatalog number. Thanks to the proven polymerfree matrix coating, it provides continuous and controlled drug delivery. The use of cardiopulmonary bypass as an adjunct to airway surgery for nonmalignant diseases in adults is not well established in the uk. Thirty patients with malignant esophageal stenosis underwent ultraflex esophageal stent deployment and were followed up for a maximum of 29 months from. Interventional bronchoscopy for benign tracheobronchial. 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.
View ordering information for ultraflex singleuse covered esophageal ng stent system distal release. 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. The ultraflex tracheobronchial stent system is provided sterile and is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. The author also provides detailed product information, recommendations, and contraindications for the use of both stents. A survey of stent designs university of southampton. A larger diameter relative stent was subsequently inserted successfully.
We are reporting two cases which demonstrate the additional benefits of using cardiopulmonary bypass during difficult bronchoscopy and complex airway stenting. Tracheobronchial stent system device description the merit endotek aeromini tracheobronchial stent system is comprised of two components. Oesophageal stent insertion for palliation of dysphagia in. The rate of tissue overgrowth was more higher with ultraflex stents, and to a. Moreover, a potential cost benefit vs surgery has been shown. 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. The material properties unique to the ultraflex esophageal stent and the diamond biliary stent along with their clinical benefits are presented in detail. 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. The ultraflex diamond stent is made of nitinol, a nickeltitanium alloy that provides a high degree of flexibility fig.
Class 2 device recall ultraflex tracheobronchial stent system. Factors to obstructive granulation tissue formation after. Respiratory infections increase the risk of granulation. This mortar has a high content of unique dry polymer, resulting in excellent adhesion to the substrate and tile. Only your physician can diagnose and appropriately treat your symptoms. The use of selfexpandable metal stents semss has had a large role in dysphagia. Stent and is engineered with outstanding flexibility, making it the only fully connected yet flexible selfexpanding stent. Boston scientifics products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular. Full text of fully covered selfexpandable metal stents. Complications of airway selfexpandable metallic stent in. 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%. 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. The ultraflex esophageal stent system maintains luminal patency in esophageal strictures caused by intrinsic or extrinsic malignant tumors. Recurrent airway obstructions in a patient with benign tracheal stenosis and a silicone airway stent.
The ultraflex esophageal and diamond biliary stents. Investigating esophageal stentplacement outcomes in. 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. After the development of technique of stent placement in esopahgus, there was revolutionary change in the management of such conditions. The ultraflex tracheobronchial stent system is provided sterile in both covered and uncovered versions and is indicated for use in the treatment of. Patients were excluded if more than one type of stent was in place at the same time. In the past, the esophagus diseases causing the patient to unable to intake oral diet such as esophageal strictures, leaks, tracheoesophageal fistulas, etc. The edges of the monofilaments are protected with silicone to avoid impaction andor tissue damage at the proximal and distal ends. All ultraflek spa products are designed and manufactured to ensure the best performance. Do airway metallic stents for benign lesions confer too. The principles of sems implanta tion in our institution under conscious sedation and local. The knitted design allows the ultraflex to adapt well into. Recurrent airway obstructions in a patient with benign.
Recently, placement of partially and fully covered metal or plastic stents has emerged as a minimally invasive treatment option. Flex vascular stent system was inspired by the native vessel and designed to overcome the constant biomechanical challenges that stents face. Numerical analysis of airflow alteration in central. Implantation of ultraflex nitinol stents in malignant. Ruptured stent covers were only seen with ultraflex stents. The use of selfexpanding metallic stents semas in the treatment benign airway obstruction is controversial. Longterm followup of ultraflex metallic stents in benign and. The covered stent can also be used for occlusion of concurrent esophageal fistula. 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. Class 2 device recall ultraflex uncovered esophageal stent. The neuroform ez stent system is authorized under a humanitarian device exemption hde.
Evolution, sxella, hanarostent, nitis, ultraflex ng, and. Covered and uncovered ultraflex stents are available to maintain esophageal luminal patency in esophageal strictures caused by malignant tumors only. 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. The pressure field was solved by the navierstokes equations. Radiological imageguided placement of covered nitis. 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. The placement of esophageal stents in different esophageal. Highly visible green sutures facilitate endoscopic visualization. Pdf the airway stents restore patency in the face of luminal compromise from intrinsic andor. Z stent cook medical requires manual loading of the. Ultraflex stent boston scientific, natick, ma, usa. Complications recorded were lower respiratory tract infections, stent migration, granulation tissue, mucus plugging requiring intervention, tumor overgrowth, and stent fracture. How i do it catheterise oesophagus with angled catheter and.
R stent is useful in rp, but remains controversial for in longterm management. The interstices of the lattice work are larger compared to those of the wallstent. The ultraflex stent was pushed into the gastric cavity. The latter includes the selfexpandable stent or classic dumon stent. We aimed to determine the clinical effectiveness of covered stent placement for the treatment of esophageal ruptures and anastomotic leaks with special. All 3 dumon stents were removed immediately due to migration. The ultraflex is composed of a woven, single strand of nitinola nickeltitanium alloywith a unique shape memory property. The stent expansion results from the physical properties of the. Posizionamento di protesi ultraflex in paziente con neoplasia. 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. For most patients stent insertion will be the quickest way of palliation as it avoids the need for referral and travel to tertiary centres. 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. Ultraflex precision colonic stent placement for palliation. The highest rate of late complications was seen in patients treated with ultraflex stents.
Before stent insertion, 24% of the subjects were subjected to bougienage and. Longterm outcomes and complications of metallic stents for. Relapsing polychondritis treated with an ultraflex. To present the complications of ultraflex selfexpandable metallic stents semss applied in patients with benign tracheobronchial diseases. Endoscopic removal of an esophageal stent after diffuse. Palliative treatment with ultraflex precision stent. The appearance of a bronchopleural fistula is a wellknown and frightening complication of pulmonary surgery. Selfexpanding plastic stent to palliate symptomatic. Stents in the proximal esophagus gastrointestinal endoscopy. Pdf the use of selfexpandable metallic stents in the airways in. The primary goal of esophageal stent insertion in patients with. The neuroform ez stent system is comprised of a selfexpanding nitinol stent, preloaded on an enhanced stent delivery wire. To the best of our knowledge, all previous studies used incidence proportions. Ultraflex spa has been a leader in steering systems for pleasure and professional boats for many years.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms. Thus, an ultraflex stent can adapt well to the irregular con. Ultraflex esophageal ng stent system boston scientific. The applied length varies according to the length of the obstruction 1015 cm with a covered length of 712 cm. 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.
The first case presents an emergency indication for cardiopulmonary bypass in a life. The stent is completely covered with a biocompatible polyurethane membrane. Ultraflex metal stent to treat duodenal cancer ingrowth. Radiological imageguided placement of covered nitis stent for palliation of dysphagia in patients with cervical esophageal cancer, dysphagia, 20, pp. In network a, when compared to the ultraflex stent, the polyflex stent increased the risk of stent migration 2. Benign esophageal ruptures and anastomotic leaks are lifethreatening conditions that are often treated surgically. Before opening the package, inspect the package for damage. There is a valuable role to avoid surgery in patients with metastases, and the need for temporary or permanent stoma1. Different methods have been used to solve this problem conservatively, from bronchial gluing to stent placement. Z stents and ultraflex stents were implanted in 7 patients for between 1 to 1 months with no complications and showed stable effects. Stent migration in one patient was related to undersizing of the stent diameter relative to the airway diameter.
This stent has a proximal flare of 23 mm to ensure fixation at the proximal edge of the tumour. Ultraflex tracheobronchial stent system boston scientific. Do not use if the package has been opened or damaged. Covered sems, such as the ultraflex stent boston scientific, massachusetts, usa are more biocompatible and some reports suggest fewer complication rates compared with silicone stents. In addition, severe pain and food obstruction were also only seen in patients treated with psems. Grasping the knots over it with biopsy forceps also allows us to reposition the stent after deployment, like in our patient. Visually inspect the tracheobronchial stent system for any sign of damage.
Using flexible bronchoscopy, 82 semas 67% ultraflex, 33% wallstent were placed in 35 patients with inoperable lesions, many with. Ultraflex nitinol stent with sutured loop ends was placed. Ultraflex precision nitinol colorectal stent ultraflex precision nitinol colorectal stent references. Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction. 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. Longterm followup and survival after ultraflex stent insertion in the management of complex malignant airway stenoses.
Remove airway ultraflex stents by flexible bronchoscope. Healing of bronchopleural fistula using a modified dumon. Despite removal of airway metallic stents by rigid bronchoscope was presented, there are few reports describing such removal by flexible bronchoscope. 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.
Esophageal stenting in the setting of malignancy ncbi. This site is not intended as a substitute for professional medical care. Insertion of selfexpandable metallic stent in an adult. Boston scientific, m00576490, boston scientific ultraflex. Ultraflex tracheobronchial uncovered stent system boston. In the management of refractory benign strictures of the oesophagus, stent usage should be carefully. In our group of patients we observed considerable differences in complications rates for different stents. 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. 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%.
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