The use of intrabronchial valves (IBV) could be a promising method to achieve lung volume reduction in patients with advanced emphysema. Due to the potential comorbidities associated with the use of these devices in humans and the potential need to adjust the therapy, the Spiration IBV system has been designed for ease of removal.
Over implant periods of up to 7 months, we evaluated bronchoscopic removal of these devices in three species: canine, ovine and porcine.
A total of 32 animals (14 dogs, 17 sheep and 1 swine) were implanted with IBV using flexible bronchoscopy. An average of 12±3 valves were implanted in each animal. Using standard cupped biopsy forceps, a selected number of devices were removed after different periods of implant duration. Procedure difficulty was evaluated after each removal and observation of the airway was done immediately after removal and in subsequent follow up procedures.
A total of 393 valves were implanted and remained in place until removed. A total of 142 valves were removed at various times. Dogs exhibited more tissue reaction adjacent to the device compared to the other two species. The removal procedure was successfully accomplished in all cases and locations. All devices were quickly removed intact, producing only minimal localized bleeding and tissue irritation. Airways distal to the implant sites were always patent and all animals recovered without complications. Subsequent follow-up observations of sites where valves were removed showed healthy airways.CONCLUSIONS: In these animal models, the IBV design allowed for easy device removal for periods up to 7 months.
IBV device removal features may allow physicians to treat complications and to adjust or modify therapy requirements as needed over time.
Implant duration (months).51234567Number of animals227662322Number of valves removed108291571045
D.H. Dillard, Spiration Inc, Shareholder, Industry, Discussion of product research or unlabeled uses of product.