Power of Precise Patient Selection
Appropriate patient selection is critical to the success of Zephyr® Valve treatment. Over time, clinical trial data have helped define the successful patient profile.1-4,6,7 The Zephyr Valve is the first endobronchial valve to receive approval from the FDA for patients with either heterogeneous and homogeneous emphysema and can be used to treat the upper and lower lobes of either lung.
COPD Clinical Workup
Zephyr Valve candidates are evaluated with standard clinical work-up.
- FEV1 <45% predicted and >15% predicted
- Heterogeneous or homogeneous emphysema
- Upper or lower lobe
- Symptomatic despite optimal medication
Lobe Treatment Planning Support with StratX®
StratX Lung Analysis Platform:
- Cloud-based quantitative CT analysis service
- Provides information on emphysema destruction, fissure completeness, and lobar volume
- Helps identify target lobes for Zephyr Valve treatment
Patients with >80% fissure completeness scores are likely to have negative collateral ventilation (CV-) and could be a candidate for Zephyr Valves
Chartis® Assesses Collateral Ventilation
The Chartis Pulmonary Assessment System:
- Proprietary balloon catheter and console with flow and pressure sensors
- Used to assess the presence of collateral ventilation (CV) within isolated lobes of the lung, which is a predictor of response to treatment
- Provides precise flow and pressure readings for specific lobes in the lung at the lobar level
Zephyr® Valves Placed
In qualifying patients, Zephyr Valves are then placed in a minimally invasive procedure.
- 30-60 minute procedure
- Typically, 3 to 5 valves placed to completely occlude the lobe
- Zephyr Valves can be removed or retracted through bronchoscope
- 3-night stay in the hospital
Assess with Certainty. Treat with Confidence.
Used prior to placement of valves, StratX and Chartis give physicians confidence in their treatment decision and are a critical addition to analysis of fissure completeness. Without Chartis, physicians may treat a lobe that has collateral ventilation, or unnecessarily rule out a patient who could have benefitted.
Patient Selection Benefit Of Chartis7
*Includes patients with “low plateau” measurements, typically not achieving TLVR when treated
**Includes patients with “low flow” readings in the target lobe, typically resulting in TLVR when treated
Patient Treatment Preference
A detailed survey of 294 severe emphysema patients evaluated how they balance potential risks and benefits. The study concluded that patients with severe emphysema value access to an interventional treatment that offers benefits above and beyond their current medical management, despite the risks associated with these treatments.8
Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.