During the development of a non-stent based intra-bronchial valve system (IBV) for the treatment of emphysema, evidence of device migration produced by coughing was occasionally observed. An anchor system was optimized to prevent device migration, minimize tissue reaction and allow removal when required.
To assess safety and efficacy the IBV anchoring system, over time in two animal species.
A total of 323 devices were implanted in 28 healthy animals (14 dogs and 14 sheep). Devices were removed and/or replaced at intervals of 1, 3 and 6 months. At each follow-up interval, some animals were sacrificed for pathological evaluation of the lungs. Also, each valve was observed for fit and location using bronchoscopy. Some devices were removed and/or replaced. After each removal, careful inspection of the airways was done.
Post-procedural coughing was observed in some of the animals. At 1 month, all 323 valves were observed in their original implant locations. All valves were found in their original implant locations in all subsequent follow-up procedures. Some valves were removed and replaced without complications using bronchoscopy and biopsy forceps. In 12 necropsies, no evidence of lung trauma was observed. Mild to moderate hyperplasia was observed in the airway areas where valves were implanted. Six animals (2 dogs and 4 sheep) were evaluated at 6 months and all 36 devices were observed in their original implant locations and 14 valves were removed without complication.CONCLUSIONS: All valves remained in place up to 6 months after implant. The current IBV design and system is safe and effective, provides reliable, atraumatic means of preventing valve dislodgement and allows easy removal if required.
An effective anchoring design is critical for achieving a safe and reliable means for the bronchoscopic treatment of emphysema using the IBV system.
X. Gonzalez, Spiration Inc, Industry,, Discussion of product research or unlabeled uses of Product.