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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CONCLUSIONS: Endobronchial targeting of peripheral airway targets is feasible using existing open-source technology. Notwithstanding the shortcomings of current commercial platforms, technological improvements in EM tracking and registration accuracy fostered by open-source technology may provide the impetus for widespread clinical uptake of electromagnetic navigation in bronchoscopy. PMID: 30428748 [PubMed - as supplied by publisher]
Source: Minimally Invasive Therapy and Allied Technologies - Category: Surgery Tags: Minim Invasive Ther Allied Technol Source Type: research
Conclusions: CLE seems a promising alternative to fluoroscopy as a guidance tool for TBCB procedures.Respiration
Source: Respiration - Category: Respiratory Medicine Source Type: research
Authors: Livi V, Barisione E, Salio M, Zuccatosta L, Romagnoli M, Praticò A, Michieletto L, Mancino L, Corbetta L Abstract Options for non-surgical tissue diagnosis of the peripheral nodule include CT scan-guided TTNA, fluoroscopy-guided bronchoscopy, radial endobronchial ultrasound (EBUS), electromagnetic navigation bronchoscopy (ENB), and virtual bronchoscopy navigation (VBN). For physicians who choose to pursue non-surgical biopsy, the decision to perform CT scan-guided or ultrasoundguided TTNA, conventional bronchoscopy or bronchoscopy guided by EBUS, ENB, or VBN will depend on a number of factors. CT sc...
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
Authors: Carlucci P, Trigiani M, Mori PA, Mondoni M, Pinelli V, Casalini AG, Conte EG, Buggio G, Villari L, Marchetti G Abstract Diseases of the pleura and pleural space are common and present a significant contribution to the workload of respiratory physicians, accounting for an annual incidence of more than 1.5 million cases in the US with the majority of cases resulting from congestive heart failure, pneumonia, and cancer 1. Although the radiographic and ultrasonographic detection of pleural abnormalities may be obvious, the determination of a specific diagnosis can often represent a challenge. Since pleural eff...
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
CONCLUSION: No significant difference in the rates of fiducial marker retention and migration were noted when comparing patients who had anchored transponders placed into small airways and a 2:1 matched cohort of patients who had other commercially available lung fiducial markers placed. In both groups, no late or chronic toxicity appeared to be related to the implanted fiducial markers. PMID: 30387242 [PubMed - as supplied by publisher]
Source: Journal of Applied Clinical Medical Physics - Category: Physics Authors: Tags: J Appl Clin Med Phys Source Type: research
Conclusion: Intraprocedural CBCT imaging with augmented fluoroscopy is feasible and effective and is associated with high DY during ENB-guided biopsies.
Source: Journal of Bronchology and Interventional Pulmonology - Category: Respiratory Medicine Tags: Original Investigations Source Type: research
Conclusion: Bronchoscopic laser interstitial thermal therapy can achieve relatively large areas of ablation of normal lung parenchyma with a low rate of periprocedural complications.
Source: Journal of Bronchology and Interventional Pulmonology - Category: Respiratory Medicine Tags: Original Investigations Source Type: research
Conclusion: Our initial experience with a novel peripheral TBNA device appears safe and effective, and may offer technical advantages over other available devices. Additional studies will be required to confirm the role of this device in the approach to bronchoscopic sampling of parenchymal lung nodules.
Source: Journal of Bronchology and Interventional Pulmonology - Category: Respiratory Medicine Tags: Brief Reports Source Type: research
Diagnosing solitary lung tumors located outside of a patient's main airways has long been a challenge, but evidence is building around a technology designed to improve access to such tumors. According to data unveiled this week at the European Respiratory Society International Congress in Paris, Broncus Medical's Archimedes virtual bronchoscopy navigation system helped to more than double the diagnostic yield for nodules with negative bronchus sign or an airway leading to the nodule. The six-year-old, San Jose, CA-based company said the Archimedes System is the only system of its kind offering real-...
Source: MDDI - Category: Medical Devices Authors: Tags: Imaging Source Type: news
We present a 2-day-old neonate with aphonia and stridor who underwent microdirect laryngoscopy. Intraoperatively, a Cohen type 4 laryngeal web was diagnosed not immediately amenable to resection. Therefore, the decision was made for endotracheal intubation and subsequent tracheostomy. After endotracheal intubation, there was acute respiratory compromise and oxygen desaturation that improved moderately after urgent tracheostomy. A chest radiograph revealed a large pneumothorax. Our experience suggests that in the presence of high-grade laryngeal webs, the possibility of intraoperative development of pneumothorax should be c...
Source: A&A Case Reports - Category: Anesthesiology Tags: Case Reports Source Type: research
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