1 the classic presentation is progressive dysphagia to both solids and liquids, often accompanied by regurgitation of undigested food and chest pain. Item Past Expiration. Symptomatic patients with achalasia who had been referred to our center were consecutively . The standard approach is to perform one dilation per session, with repeat dilations being performed according to symptomatic recurrence. Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . . Skip to Main Content; National Library of Medicine NLM Tools and Resources . References 1. Gastrointest Endosc 62: 427-431 Pneumatic balloon dilation is an effective and widely used nonsurgical treatment for the relief of functional obstruction of the gastroesophageal junction in. The patients were subjected to achalasia dilation after preprocedural assessment. There have been 11 studies looking at the success rate of dilation using a Rigiflex balloon dilator in patients with achalasia, 297 patients were available for follow-up (Table I). (Rigiflex 30-mm pneumatic balloon) is simultaneously insufflated and desufflated in the esophagus during LHM to assess myotomy in 50 consecutive patients. The disease occurs equally in both genders and can occur at any age, but is more common between the ages of 30 and 50 [1-6]. Packaging. Abbott. Question - Answer 0. Pneumatic dilation is the initial therapy for primary esophageal achalasia. Pneumatic balloon dilatation is the treatment of choice for esophageal achalasia. Add to Cart. Was: $40.00 Now . Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. Description. Currently, pneumatic dilation (PD) using Rigiflex (Microvasive, Natick, MA) balloon dilators is the most common and effective nonsurgical treatment for achalasia. The 3.0-cm balloon was always used first. Their ages at the time of their initial dilatation ranged from 19 to 66 years with a mean of 46.2 years. 2, 3 on radiography, poor esophageal A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to . 035747. AccessGUDID - RIGIFLEX II (08714729719120)- Single Use Achalasia Ballon Dilator. . Graded pneumatic dilation using Rigiflex ballon is one of the therapeutic modalities that had not been evaluated in a large long-term study. Catheters are available in 30, 35, and 40 mm diameters with most patients' first dilation starting at 30 mm. These features lead to a failure in the passage of bolus via the esophagogastric junction. Graded pneumatic dilation using Rigiflex balloon is one of the therapeutic modalities that had not been evaluated in a large long-term. Price: $49.99. Treatment of achalasia targets the mechanical disruption of the muscle fibers of the lower esophageal sphincter by either pneumatic dilation or surgical myotomy. Dilatation with low-compliance 30- or 35-mm pneumatic balloons leads to therapeutic success in 70-80% of cases. In summary, pneumatic dilatation for the treatment of achalasia using modern instruments, such as the Rigiflex dilator, is safe and effective. It is generally observed that good responses sustained for more than 5 years appear in at least 40% of cases. Biliary Stricture And Stone. Balloon Length (cm) Inflation Pressures Working Length (cm) Catheter Size Recommended Guidewire** (mm) (Fr) (psi) (kPa) (mm) (Fr) (in) Packaging M00554500 08714729719106 30 90 10 20 138 90 4.6 14 .038 Each $30.00) Model #: 5451 OEM: Boston Scientific Expiration Date: 2021 Size . Achalasia is a well-defined esophageal motor disorder. Therapeutic endoscopists continue to use various available dilators in accordance with their training, experience, and preferences. Follow-up data were collected retrospectively from patient notes and telephone interviews with the patients and/or their local doctors (mean follow-up, 26 months). This method is accepted as the standard of care in achalasia in view of good long-term response and relatively low complication rates. The procedure was successfully done in all the patients, and there were no procedural failures. Packaging. The endoscope is withdrawn fully. The balloon system consists of a 10-cm long, non-compliant balloon mounted on a flexible catheter with radiopaque markers defining the balloon location. Excellent improvement in dysphagia, pain, and regurgitation was observed in 92.9%, 89.3%, and 89.3% patients at 24 hours, 6 weeks, and 6 months after dilation, respectively. A 30mm Rigiflex balloon was used under fluoroscopic control. Willis successfully treated a patient by dilating the LES with a cork-tipped whalebone. . Achalasia is a well- defined esophageal motor disorder. We performed a total of 47 dilations in 29 consecutive patients with achalasia using the Rigiflex dilators. Dysphagia, heartburn, aspiration, regurgitation, and weight loss are the most Rigiflex II Single-Use Achalasia Balloon Dilator, 35 mm Inflated O. D., 10 cm Balloon Length, 90 cm Working Length, MSPV / Government Only. Although some studies reported a perforation rate of 5-7% with Rigiflex balloon, 28, 29 this dilator seems to be the most effective and the safest nonsurgical therapy in achalasia with overall complication rate of 3%. The standard dilator used to treat other causes of difficulty swallowing has a maximum diameter of 20 mm (about 0.75 inch). SIMM00554510. The balloon is centered over the lower esophageal sphincter and inflated with air. We aimed at evaluating long-term efficacy of graded Rigiflex pneumatic dilation in the treatment of achalasia. We aimed at evaluating long-term efficacy of graded Rigiflex pneumatic dilation in the treatment of achalasia. However, a 30 mm Rigiflex balloon is typically used for the initial dilation in most adults [ 8 ]. There were 10 females and 5 males. Balloon Dilators RIGIFLEX II Product Tech Specs RIGIFLEX II Achalasia Balloon Dilators Balloon Length (CM) 10.0 Recommended Guidewire (IN) 0.038 Balloon Inflated OD (MM) 30 35 40 Working Length (CM) 90 Package Quantity 1 Request Pricing Product Documentation Instructions for Use Instructions for use are found inside the product packaging. This video shows the balloon dilatation of the lower oesophageal sphincter in a patient with achalasia. Decrease Quantity of RIGIFLEX II Single Use Achalasia Balloon Dilator - 40mm x 10cm x 90cm Increase Quantity of RIGIFLEX II Single Use Achalasia Balloon Dilator - 40mm x 10cm x 90cm. Main predictors of poor 11, response to EBTI are lack of an initial symptom-atic response and residual LES pressure of 18 mmHg or greater after EBTI. The procedure was successful in 251 patients (85%) with a mean follow-up ranging from 3 to 43 months. 1-3 Treatment success varies from 50% to 93%. Achalasia is a primary oesophageal motoric disorder; it is a rare disease with an annual incidence of approximately 1/100,000 patients and a prevalence rate of 10/100,000 patients. Biliary Stricture And Stone. Symmetry OTW Balloon Dilatation Catheter - 3.5mm x 40mm x 90cm. Rigiflex II Single-Use Achalasia Balloon Dilator, 40 mm Inflated O. D., 10 cm . Adding to cart The item has been added . Model #: B1080-040 Armada 35 PTA Catheter - 8.0mm x 40mm x 80cm . Summary of Data Regarding Efficacy Stone Management; Biliary Stents; Pancreatic Stents; Biopsy RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. The mean time of the procedure was 8 minutes, and patient compliance and Since its inception, the conventional technique has been performed under direct fluoroscopic control with or without a guidewire. This enables confirmation that the dilating balloon is appropriately centred at the gastro-esophageal junction. CRE Wireguided Balloon Dilatation Catheter - Esophageal/Pyloric/Colonic - 12mm x 13.5mm x 15mm. Recently, polyethylene balloon (Rigiflex) dilators have been used with varying success and complication rate. The aim of this study was to evaluate the efficacy of graded balloon dilatation, to achieve symptomatic improvement in patients with achalasia. Achalasia is a motor disorder characterized by a decreased or absent esophageal body peristalsis and inability to sufficiently relax the lower esophageal sphincter (LES). Background: Pneumatic balloon dilation is the most effective nonsurgical treatment to relieve functional obstruction of the gastroesophageal junction in achalasia. Rigiflex II Single-Use Achalasia Balloon Dilators Rigiflex II Single-Use Achalasia Balloon Dilators* Order Number GTIN Balloon Inflated O.D. We aimed at evaluating long-term efficacy of graded Rigiflex pneumatic dilation in the treatment of achalasia. 1 EA. In stock. There were no patient complications. Code Information: Lot/Batch Number: 091541: Recalling Firm/ Manufacturer: Boston Scientific . 5 However, the technique of pneumatic dilation has not yet been standardized. Make Offer. Achalasia of the cardia is a disorder of esophageal motility characterized by loss of peristalsis and failure of relaxation of the lower esophageal sphincter (LES) on swallowing.1 Sir Thomas Willis first described achalasia in 1674. Even the single session of dilatation is successful in maintaining long-lasting dysphagia-free interval. It was reported that balloon was removed from the patient and that a second rigiflex ii balloon dilatation catheter was used to complete the procedure. The wide variety of techniques described for performing this procedure appear to have little effect on the risk of esophageal perforation, which remains low. Graded pneumatic dilation using Rigiflex balloon is one of the therapeutic modalities that had not been evaluated in a large long-term study. We conclude from our study that, though the era of POEM has already arrived, pneumatic balloon dilatation is still the most commonly performed endoscopic procedure for achalasia, especially in resource-poor developing countries. Pneumatic balloon dilation is the most effective nonsurgical treatment modality to relieve dysphagia in patients with achalasia. 1 This wide response range may be a function of inconsistent reported follow-up in treated patients. 3, 30 Before using graded PD, we had three perforations in the first 85 sessions of balloon dilatation (3.5%) whereas no . 1 EA. Go to: Footnotes achalasia is a primary motor disease of the esophagus, manometrically characterized by loss of peristalsis and a non-relaxing lower esophageal sphincter (les). The pneumatic dilating balloon used to treat achalasia is 30 to 40 mm (about 1.2 to 1.6 inches) in diameter. Description. CiteSeerX - Document Details (Isaac Councill, Lee Giles, Pradeep Teregowda): Abstract- Achalasia is a well-defined esophageal motor disorder. A Rigiflex Balloon (Boston Scientific, MA) is then inserted ( Figure 1) over the guidewire and passed under fluoroscopic guidance until centred over the gastro-esophageal junction ( Figure 2 ). Description. The dilations were performed in a progressive manner starting with a 15-mm-diameter balloon and progressing to 20-, 30-, and 40-mm balloons, as required.