Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
Evaluation of the Spiration® Valve System for Emphysema to Improve Lung Function
EMPROVE is a multicenter, prospective, randomized, controlled study designed to evaluate the
 safety and long-term effectiveness of the Spiration Valve System in patients with emphysema.

 Patients appropriate for the EMPROVE study are those who are currently on medical treatment
 but still symptomatic.

 EMPROVE also accepts α-1 antitrypsin deficiency patients.
The Spiration Valve is a small, one-way valve that is used to block air from entering
 diseased portions of the lung. This helps to reduce the volume in diseased lung due to
 hyperinflation. Volume reduction of diseased lung has been shown to improve lung function and
 other quality of life measures for people living with emphysema.

 The Spiration Valve is placed in the diseased section of the lungs using a tool called a
 bronchoscope. A bronchoscope is a small tube that has a camera on the end. The bronchoscope
 enters the lungs through the mouth. The Spiration Valve is delivered and placed in the
 targeted airways via another thin tube called a catheter that travels through the
 bronchoscope.

 -  Once in place, the Spiration Valve expands and contracts with breathing, creating a
 complete seal around the airway

 -  The seal blocks air from entering the target lobe while at the same time allowing
 trapped air and fluids to escape.

 -  This causes the diseased (hyper-inflated) lung to reduce in volume or collapse

 -  Studies have shown volume reduction may allow healthier lung to function better

 -  More information and a description of the Spiration Valve System can be found on the
 EMPROVE clinical trial website, www.EmphysemaTrial.com

 Safety and outcomes of the Spiration Valve System in emphysema have been published in several
 peer-reviewed journals. The articles listed below represent a summary of existing literature
 regarding the use of the Spiration Valve System for the treatment of emphysema. The selected
 articles are being provided to help understand the body of data describing the use of the
 Spiration Valve System.

 1. Unilateral Versus Bilateral Endoscopic Lung Volume Reduction: A Comparative Case Study,
 NCT00995852

 Eberhardt R, Gompelmann D, Schuhmann M, Heussel CP, Herth FJ. Complete unilateral vs
 partial bilateral endoscopic lung volume reduction in patients with bilateral lung
 emphysema. Chest. 2012 Oct;142(4):900-908

 2. Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the
 Treatment of Severe Emphysema (IBV®Valve), NCT00475007

 Wood DE, Nader DA, Springmeyer SC, Elstad MR, Coxson HO, Chan A, Rai NS, Mularski RA,
 Cooper CB, Wise RA, Jones PW, Mehta AC, Gonzalez X, Sterman DH; IBV Valve Trial Research
 Team. The IBV Valve trial: a multicenter, randomized, double-blind trial of
 endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014
 Oct;21(4):288-297

 3. European Multi-Center Post Market Study of the IBV Valve System, NCT00880724

 Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar
 M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European
 study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012
 Jun;39(6):1319-1325
Inclusion Criteria:

 -  Subject has severe and heterogeneous emphysema with severe dyspnea

 -  Subject certified to meet the criteria of ATS/ERS guidelines for management of stable
 COPD

 -  Subject must be able to demonstrate physical ability to participate in the study by
 performing a 6-minute walk distance of ≥ 140 m

 -  Subject has abstained from cigarette smoking for 4 months and is willing to abstain
 throughout the study

 -  Pulmonary Function Testing Results (PFT's) demonstrate:

 -  FEV1 ≤ 45% of predicted

 -  RV ≥ 150% of predicted

 -  TLC ≥ 100% of predicted

 Exclusion Criteria:

 -  Patient has a BMI < 15 kg/m2

 -  Arterial Blood Gas Level (ABG) indicates:

 -  PCO2 > 55 mm Hg

 -  PO2 < 45 mm Hg on room air

 -  Subject has a diffuse emphysema pattern

 -  Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day

 -  Subject has an active asthma (>15 mg of prednisone daily)

 -  Giant bulla (> 1/3 volume of lung)

 -  Pulmonary hypertension

 -  Subject with prior major lung surgery or recent hospitalization for COPD exacerbation
 or respiratory infections