STRIVE Post-Market Registry Study
STRIVE Post-Market Registry Study
This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term
 safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe
 emphysema in a post-market setting.
This post-market study is a single-arm, prospective, multi-center Registry. It is designed to
 assess 36-month safety and effectiveness of this FDA approved product in a post-approval
 setting, and to support the continued assessment of Spiration Valve System therapy for the
 treatment of severe emphysema in the United States.

 Subjects who are eligible and consent to be in this study, will be monitored for outcome data
 from baseline through 3 years post-first implant.
Inclusion Criteria:

 1. Adult patients with shortness of breath and hyperinflation associated with severe
 emphysema and evidence of low collateral ventilation.

 2. Subjects must understand and voluntarily sign an informed consent form.

 Exclusion Criteria:

 1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU
 requirements.

 2. Subjects who were withdrawn from this study for any reason will not be allowed to
 re-enroll.

 3. Subjects who have incomplete screening or baseline data.