ABOUT US

A major advance in the prevention of percutaneous lung biopsy-related pneumothorax.

In 2008, Surgical Specialties Corporation began undergoing research with a proprietary hydrogel plug that could prevent air leakage from the lung, a condition commonly known as pneumothorax. As the studies of the product began to yield positive results, Surgical Specialties Corporation was granted CE Mark and the product was soon launched in Europe as the Bio-Seal™ lung biopsy tract plug system.

The clinical study results for Bio-Seal™ lung biopsy tract plug system were published in the Journal of Vascular and Interventional Radiology in 2010. The trial assessed the safety and efficacy of Bio-Seal™ lung biopsy tract plug system in patients undergoing lung biopsy procedures and demonstrated a statistically significant clinical benefit in the group receiving the Bio-Seal™ lung biopsy tract plug system.

The purpose of this clinical study was to assess the safety and efficacy of an expanding hydrogel plug in reducing pneumothorax rates associated with CT-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. The Bio-Seal™ lung biopsy tract plug system treatment arm hit the primary end point of clinical success, absence of pneumothorax at each time period. Based on the per-protocol population, clinical success rate was 85% using the Bio-Seal™ lung biopsy tract plug system 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™ lung biopsy tract plug system subjects as compared to the control group in various secondary endpoints, including fewer Bio-Seal™ lung biopsy tract plug system subjects admitted to the hospital for pneumothoraces (9.4cm3 vs. 13.6cm3), fewer chest tubes placements in Bio-Seal™ lung biopsy tract plug system patients (3.5cm3 vs. 10.7cm3), and fewer additional chest x-rays required in Bio-Seal™ lung biopsy tract plug system patients (17cm3 vs. 31cm3).

The US Food and Drug Administration reviewed all clinical data for the "Bio-Seal™ lung biopsy tract plug system and approved its use in December 2012.

The Bio-Seal™ lung biopsy tract plug system became commercially available in the United States during the first quarter of 2013 under the brand name BioSentry™ and registration is proceeding in select International markets.