Surgical Robotics Technology

Ambu Secures FDA Clearance for Combined Single-use Bronchoscope and Sampling System

ambu

Ambu has today announced US FDA 510(k) clearance of a combined single-use bronchoscope and specimen sampling system.

We’ve seen a distinct need for a simple, all-in-one solution for certain types of procedures where clinicians need to clear the airways of a patient or take fluid samples from the lungs. We’re the only company to offer a closed-loop system, and now we combine our single-use bronchoscope with a unique tailormade accessory that helps hospital staff be more effective and avoid the risk of exposure to lung fluid or secretion from for instance COVID patients,” says Bassel Rifai, Chief Marketing Officer at Ambu.

The combined solution – Ambu® aScope™ 4 Broncho Sampler Set – is a sterile, single-use solution for bronchial wash (BW) and bronchoalveolar lavage (BAL) procedures. The 510(k) clearance covers the combined solution and means that Ambu can now market this all-in-one solution in the USA.

Improves workflow, safety and efficiency
Dr. Suveer Singh – Critical Care and Respiratory Medicine Consultant at Royal Brompton and Chelsea & Westminster Hospitals in London – is an experienced user of Ambu’s BronchoSampler solution and co-author of two publications on its use1.
Ambu’s combined system simplifies the sampling process with less steps from plan to procedure to completion. The convenience of the ‘click and go’ technique for the BronchoSampler container and suction saves time, prevents detachment/reattachment of the suction tubing, potential loss of specimen and reduces the risk of sample contamination. The fact that you do not break the circuit improves the workflow, safety and efficiency of the procedure whilst increasing the percentage of sample yield compared to the historic standards of collection from BAL. This has been important as part of expert recommendations for safe bronchoscopy in ITU during COVID. Comparative randomised study data for safety and efficacy are ongoing,” says Dr. Singh.

Leading supplier of single-use endoscopes
Ambu launched the world’s first single-use flexible bronchoscope, the Ambu® aScope™ in 2009. A decade later, in 2020, over one million Ambu single-use endoscopes were used around the world, and Ambu has now developed scopes for a broad range of clinical areas making Ambu the largest and most innovative supplier of single-use endoscopes2. Ambu has announced the launch of 20 new devices for single-use endoscopy over the next three years with the aim of increasing patient safety and improving healthcare workflows.

1Singh S, Shah PL. Safe and Efficient Practice of Bronchoscopic Sampling from Mechanically Ventilated Patients: A Structured Evaluation of the Ambu Bronchosampler-Ascope 4 Integrated System. Respiration. 2021;100(1):27-33. doi: 10.1159/000511982. Epub 2021 Jan 7. PMID: 33412544.

Luo F, Darwiche K, Singh S, Torrego A, Steinfort DP, Gasparini S, Liu D, Zhang W, Fernandez-Bussy S, Herth FJF, Shah PL. Performing Bronchoscopy in Times of the COVID-19 Pandemic: Practice Statement from an International Expert Panel. Respiration. 2020;99(5):417-422. doi: 10.1159/000507898. Epub 2020 Apr 28. PMID: 32344422; PMCID: PMC7251585.

2Frost & Sullivan, 2021, https://best-practices.frost.com/ambu_award

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