Positive 1-month safety results for Medtronic ’ s Navigate bronchoscopy trial

Medtronic (NYSE:MDT) today released 1-month data from the Navigate trial of its superDimension LungGPS system, touting the device as safe and effective based on the preliminary results. A total of 1,289 patients have been enrolled in the trial to date, which spans 37 sites across Europe and North America. The trial looks to evaluate the performance of Fridley, Minn.-based Medtronic’s LungGPS electromagnetic navigation bronchoscopy technology the SuperDimension device uses to navigate the lungs. The initial data comes from 500 procedures, 497 of which were lung lesion biopsies, 91 for fiducial placement and 9 for dye marking. The study reported a 4.4% rate of pneumothorax, with a 2.2% of the pneumothorax cases grade 2 or higher. The rate of bronchopulmonary hemorrhage was reported at 2.4%, with grade 2 or higher at 1%. Grade 4 respiratory failures were at 0.4% A single death was associated with the procedure, according to the study. Navigation was successful in 90.8% of cases, with 565 lesions investigated in the 1-month period. Diagnosis rate for malignant lesions was 45.2%, with 43.3% diagnosed as nonmalignant and 11.5% as inconclusive. Study authors touted a low rate of adverse events, but said that more data would be required to get a more accurate picture of the device’s safety and efficacy. “In the first 500 subjects enrolled, preliminary 1-month data demonstrate low adverse event rates among a generalizable cohort. Continued enrollment and 24-month fol...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Imaging Respiratory Medtronic Source Type: news

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The results of the randomised controlled trials investigating the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) are promising, and have led to their inclusion in treatment guidelines, US Food and Drug Administration approval and inclusion in routine care in an increasing number of countries. The one-way valve treatment has advanced and is now a regular treatment option. However, this new phase will lead to new challenges in terms of implementation. We believe that key issues in future research concern advanced patient selection, improved methods for target lobe selection, increased knowledg...
Source: European Respiratory Review - Category: Respiratory Medicine Authors: Tags: COPD and smoking Review Source Type: research
Conclusions: This study showed that Reversers were safe and feasible for bronchoscopic lung volume reduction in pigs.Respiration
Source: Respiration - Category: Respiratory Medicine Source Type: research
​Seventy-five percent of trauma injuries involve some kind of thoracic insult, a quarter of which need a procedural intervention like a chest tube. (Surg Clin North Am 2007;87[1]:95; http://bit.ly/2HaoX90.) Long-term illness, lung disease, and post-operative complications may cause pleural effusions or a pneumothorax, so treating these conditions quickly can significantly decrease patient morbidity and mortality. Other indications for chest tube placement include:Trauma: Pneumothorax, hemopneumothorax, or tension pneumothoraxLong-term illness: Pleural effusion (cancer, pneumonia)Infection: Empyema, purulent pleuriti...
Source: The Procedural Pause - Category: Emergency Medicine Tags: Blog Posts Source Type: blogs
Thoracoscopic resection of small subsolid nodules is challenging and requires preoperative localization. We investigated the efficacy, safety, and factors affecting accuracy in localizing pulmonary nodules with electromagnetic navigation bronchoscopy (ENB)-guided dye marking. Patients with small subsolid nodule(s) who underwent thoracoscopic resection after ENB-guided dye marking were retrospectively reviewed. Dye marking was performed at the nearest pleura and the localized nodule(s) was resected thoracoscopically. Efficacy was evaluated by success rates of dye marking and resection of nodules. Navigation accuracy was re...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Abstract A person presented with multiple gunshot injury. Chest x-ray &CT whole body trauma protocol was done which showed multiples pellets of bullet in abdomen and one bullet in elbow according to entry wound. There was an entry wound without any bullet in left maxillofacial region however there was no exit wound. A bullet was noticed in tracheobronchial tree. There was no pneumothorax any signs of chest trauma or any pneumomediastinum. It is assumed that the bullet first hit the left cheek (maxilla) and lost its momentum. As the patient lost consciousness and had a fall leading to inhalation (aspiration) of...
Source: Respiratory Care - Category: Respiratory Medicine Authors: Tags: Respir Med Case Rep Source Type: research
Publication date: Available online 5 February 2019Source: Respiratory Medicine Case ReportsAuthor(s): Ashish K. Prakash, Anand Jaiswal, Ankit Aggarwal, B. Datta, Sangeeta Khanna, K.K. Handa, Yatin MehtaAbstractA person presented with multiple gunshot injury. Chest x-ray &CT whole body trauma protocol was done which showed multiples pellets of bullet in abdomen and one bullet in elbow according to entry wound. There was an entry wound without any bullet in left maxillofacial region however there was no exit wound. A bullet was noticed in tracheobronchial tree. There was no pneumothorax any signs of chest trauma or any p...
Source: Respiratory Medicine Case Reports - Category: Respiratory Medicine Source Type: research
Recently published results of a large, multicenter trial could go a long way toward boosting adoption of electromagnetic navigation bronchoscopy (ENB) procedures using Medtronic's superDimension navigation system to aid in lung cancer diagnosis, staging, and treatment. The 12-month results of the NAVIGATE study were published in the Journal of Thoracic Oncology. "It's not enough anymore to just make a really amazing new technology, it has to be backed with clinical and economic evidence and one that allows really broad adoption around the globe to really impact as many patients as we can," Emily Elswi...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
Conclusion The ENB biopsy plus Massage staining technique caused very few complications, and provided high precision, which warrants further application.
 DOI: 10.3779/j.issn.1009-3419.2019.01.04
Source: Chinese Journal of Lung Cancer - Category: Cancer & Oncology Source Type: research
Conclusion: This position statement is an attempt to provide practical recommendations for the performance of BLC in DPLDs.
Source: Lung India - Category: Respiratory Medicine Authors: Source Type: research
A 71-yr-old female with a complicated medical history, most notable for laryngeal stenosis, was transferred from an outside hospital after an emergent cricothyroidotomy during cardiopulmonary resuscitation. Upon her arrival to our hospital, a chest tube was inserted for suspected tension pneumothorax in the setting of hemodynamic instability. Chest x-ray film demonstrated free air under right hemidiaphragm (red arrow in left panel). Follow-up axial and coronal cuts of computed tomography of the chest and abdomen revealed moderate-sized pneumoperitoneum (red arrows in right panel) without any obvious abdominal visceral inju...
Source: Anesthesiology - Category: Anesthesiology Source Type: research
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