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LungPoint™ Virtual
Bronchoscopic Navigation
The Broncus LungPoint Virtual Bronchoscopic Navigation system leverages the power
of CT imaging and advanced registration algorithms to accurately guide you through
the lung airways to a preselected target location. No extra hardware, setup or
registration procedures are required!
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Yield™ Transbronchial
Coring Needle
The Yield needles enable the acquisition of tissue samples
for histology and cytology. These 18 and 21 gauge needles
have a proprietary coring tip to cut and capture samples.
The flexible needle shaft gives you access to mediastinal
lymph nodes. And the specially-designed handle has actuation
stops in 5 mm increments to give you better control.
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Yield™ Mini
Doppler Probe
Use the Doppler probe to listen for the sounds of blood
flow behind the airway wall before proceeding with TBNA or
TBB. And the catheter fits inside the Yield needles, enabling
you to easily scan the airway wall right before biopsy.
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Investigational Airway Bypass Procedure
The Airway Bypass procedure is performed under general anesthesia or deep sedation using bronchoscopy and the Exhale® Doppler
Probe, the Exhale® Transbronchial Dilation Needle and the Exhale® Drug-Eluting Stent (DES). These devices are all designed with a long
flexible catheter shaft that is inserted through the working channel of the bronchoscope.
The Exhale Doppler System identifies the presence or absence of blood vessels at or near the site where the passage and stent are to be
placed. The Exhale Doppler Probe has an ultrasound transducer at its distal tip. It connects via an electrial cable to the Exhale Doppler
Processing Unit (DPU) and is inserted through the bronchoscope. The DPU and Doppler probe produce audio signals if a blood vessel is
present (i.e., the user will hear pulsing or rushing sounds that indicate blood flow). These sounds are heard through the adjustable speaker
on the front panel of the DPU. The area for stent placement is explored with the Doppler probe before proceeding.
Once an area for passage creation is identified, the Exhale Transbronchial Dilation Needle catheter is advanced through the bronchoscope and the needle is extended to make a new opening in the airway wall. Once the needle is retracted, the balloon is dilated using an inflation syringe to enlarge the passageway.
A second scan of this area with the Doppler Probe confirms that there are no blood vessels nearby before the stent is placed.
The Exhale Drug-Eluting Stent is pre-loaded on a balloon delivery catheter, which expands (using an inflation syringe) to place the stent in the newly-made passage. The stent (3.3 mm inner diameter, 5.3 mm outer diameter, 2 mm in length when expanded) is composed of stainless steel and silicone that contains the drug paclitaxel, which is intended to inhibit fibrotic or other tissue growth in the passage. The stent provides support and helps keep the passage connecting the lung tissue to the natural airway open over time.
The number of stents placed will be determined by the investigator’s assessment of the anatomic features of the airways. Up to six drug-eluting stents (targeting one in each of the upper and lower lobes of both lungs and one each in the two lobes with the most damage) will be placed.
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