Angiotech reports positive results from Bio-Seal lung biopsy device study

The trial assessed the safety and efficacy of Bio-Seal in patients undergoing lung biopsy procedures and demonstrated a statistically significant clinical benefit in the group receiving BioSeal.

The purpose of this clinical study was to assess the safety and efficacy of an expanding hydrogel plug in reducing pneumothorax rates associated with computed tomography-guided lung biopsy. The prospective, randomized, controlled clinical study enrolled and randomized 339 investigational patients at 15 different investigational sites. Inspiratory upright chest x-rays were performed at 30 to 60 minutes, 24 hours and 30 days after treatment.

According to the company, the Bio-Seal treatment arm hit the primary endpoint of clinical success, absence of pneumothorax at each time period. Based on the per-protocol population, clinical success rate was 85% using Bio-Seal and 69% in the control group. This difference was statistically significant (p=0.002).

Although not powered for statistical analysis, positive trends were also observed for Bio-Seal subjects as compared to the control group in various secondary endpoints, including fewer Bio-Seal subjects admitted to the hospital for pneumothoraces (9.4% versus 13.6%), fewer chest tube placements in Bio-Seal patients (3.5% versus 10.7%), and fewer additional chest x-rays required in Bio-Seal patients (0.6% versus 5.3%), the company said.

William Hunter, president and CEO of Angiotech, said: “We are extremely pleased that the Bio-Seal treatment arm hit the primary endpoint of clinical success. These results indicate that Bio-Seal improves the existing technology used to diagnose lung cancer by significantly reducing the rates of pneumothorax.”