Spiration Valve System
A Proven New Direction in Severe Emphysema Treatment

The Spiration Valve System is an innovative endobronchial therapy that offers patients with severe emphysema a customized, minimally invasive treatment option for lung volume reduction with a favorable risk-benefit profile. Patients treated with the Spiration Valve System in clinical trials experienced improvements in breathlessness, lung function, and quality of life.1


Dr. Gerard J. Criner, MD, FACP, FACCP
Recent clinical trials have shown that endobronchial valve treatment is going to become part of the standard of care in patients with advanced emphysema and hyperinflation.
– Dr. Gerard J. Criner, MD, FACP, FACCP

ENDOBRONCHIAL VALVE TREATMENT

FOR SEVERE EMPHYSEMA

Emphysema is a type of chronic obstructive pulmonary disease (COPD) which is progressive in nature and characterized by loss of elasticity and alveolar enlargement. As a result, emphysematous lobes become hyperinflated and affect normal breathing.

 

A novel therapy for severe emphysema, bronchoscopic lung volume reduction (BLVR) achieved using endobronchial valves is a minimally-invasive solution for lung volume reduction in patients who are already on optimal medical management.

 

In the right patients, endobronchial valve treatment can significantly improve the symptoms of emphysema by redirecting air away from diseased parts of the lung to healthier parts, reducing hyperinflation and improving lung function.1

 

Based on safety and efficacy data from multiple international clinical studies, bronchoscopic lung volume reduction (BLVR) using endobronchial valves is now recommended by numerous prominent guidelines as a treatment option for advanced emphysema. These include:

  • 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD)2
  • National Institute for Health and Care Excellence. Interventional Procedures Guidance (NICE)3

CLINICAL OUTCOMES

Clinical Outcomes

SPIRATION VALVE SYSTEM

The unique umbrella-shaped design of the Spiration Valve redirects air from diseased parts of the lung to healthier parts, all while allowing trapped air and secretions to escape naturally along the airway wall, so that patients may breathe easier. The design of the valve allows for flexible placement in tortuous anatomy, such as airways in the upper lobe, independent of airway depth or absence of a carina.

Secure Valve Positioning

The first and only valve with anchors to prevent migration and expectoration.

Versatile Access

Anchor design allows more flexibility as to where to deploy valves independent of airway depth or access to a carina.

Versatile Access

Anchor design allows more flexibility as to where to deploy valves independent of airway depth or access to a carina.

Minimal Tissue Contact

The first and only valve with an umbrella design to allow natural movement of air and mucus in the proximal direction.

Easy Valve Removal

The first and only valve designed to facilitate retrieval with 360° access to the removal rod.

Custom Fit

Multiple sizing options with 4 valve sizes ranging from 5mm – 9mm.

Kirk G. Voelker, MD

I really appreciate the elegance and the design of the Spiration Valves.

– Kirk G. Voelker, MD

SeleCT®

PATIENT SELECTION

A decade of clinical studies shows appropriate patient selection to be one of the most important predictive factors of an effective response to bronchoscopic lung volume reduction with endobronchial valves. 

A thorough patient evaluation, examination for any comorbidities, and analysis of the patient’s HRCT information and quantitative computed tomography (QCT) results are critical to successful outcomes.5

SeleCT is a completely non-invasive patient screening solution that provides key measures of emphysema severity, fissure integrity, and heterogeneity. 

These measures are provided in an easy-to-read report to assist with selecting qualified patients and potential target lobes for improved outcomes using bronchoscopic lung volume reduction (BLVR). 

SeleCT is the only QCT service to offer rapid results that include a qualified overread by a certified thoracic radiologist.†

Emphysema Severity

Emphysema Severity

Allows physician to quickly identify the most diseased lobe.
Heterogeneity

Heterogeneity4,5

Differentiates target and ipsilateral lobe emphysema to facilitate redirection of ventilation to healthier tissue.

Fissure Integrity

Fissure Integrity

EMPROVE trial results confirmed radiographic assessment of fissure completeness to be a reliable surrogate for collateral ventilation.


Procedure Steps


ALPHA-1 ANTITRYPSIN DEFICIENCY

ALPHA-1 ANTITRYPSIN DEFICIENCY

Alpha-1 antitrypsin deficiency is a genetic condition and can often result in Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema symptoms in patients of any age.

The Spiration Valve has been studied and shown to benefit these patients. Spiration Valve placement resulted in improvements in lung function, quality of life, and shortness of breath.1


1. Criner GJ, Delage A, Voelker K. Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial. Eur Respir J. 2018;52(suppl 62). doi:10.1183/13993003.congress-2018.OA4928

2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD, 2019. http://golcopd.org

3. https://www.nice.org.uk/guidance/ipg600/resources/endobronchial-valve-insertion-to-reduce-lung-volume-inemphysema-pdf-1899873854992069. Accessed 2018.

4. Slebos DJ, Shah PL, Herth FJ, et al. Endobronchial Valves for Endoscopic Lung Volume Reduction: Best Practice Recommendations from Expert Panel on Endoscopic Lung Volume Reduction. Respiration. 2017;93(2):138-150.

5. Schuhmann M, Raffy P, Yi Y, et al. CT Predictors of Response to Endobronchial Valve Lung Reduction Treatment: Comparison with Chartis. Am J Respir Crit Care Med 2015; 191(7):767-774; doi:10.1164/rccm.201407-1205OC.

6. Hogarth DK, Delage A, Zgoda MA, Reed MF. American Thoracic Society International Conference Abstracts. American Thoracic Society; 2018:A7754-A7754. doi:10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7754.

7. Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014;21(4):288-297. doi:10.1097/LBR.0000000000000110.

Criteria to determine eligible patients for the treatment are based upon findings established by the EMPROVE clinical trial. These recommendations are not meant to replace patient-specific clinical judgement.  SeleCT report should not be considered a complete radiological analysis.

Spiration is a registered trademark of Olympus Respiratory America.