Surgical Specialties' BioSentry Track Sealant System Approved for 17-Gauge Use in Europe

May 23, 2016—Surgical Specialties Corporation announced approval in Europe for expanded labeling for its BioSentry track sealant system, allowing the device to be used with a larger 17-gauge biopsy system. Originally CE Mark approved with a 19-gauge system, the BioSentry can now be used in a greater number of percutaneous transthoracic lung biopsy procedures. Use of the BioSentry system has demonstrated reduced risk of pneumothorax and subsequent adverse events, stated the company.

In the company’s announcement, Prof. Tomas Vogl, MD, from Frankfurt University, Germany, commented, “This change is of significant benefit for European radiologists because the addition of 17-gauge biopsy system compatibility allows larger tissue samples that give us better diagnosis and treatment options. Previously, we have not had any preventative measures to reduce pneumothorax and related adverse events after a lung biopsy until now with BioSentry.”

Surgical Specialties describes the BioSentry system as delivering a hydrogel plug placed into the lung along the biopsy needle tract, which expands to prevent air from leaking out and creating a pneumothorax. In a prospective, randomized, multicenter clinical trial of 339 patients, BioSentry significantly reduced the risk of pneumothorax by a relative risk reduction of > 50%. The trial also demonstrated relative risk reduction of additional radiographs by 44%, chest tube placements by 67%, and postprocedure admissions by 35%. Pneumothorax is the most common cost and care-intensive complication of CT-guided percutaneous lung biopsy, occurring in 15% to 42% of patients, noted Surgical Specialties.

Brennan Marilla, the company’s Chief Commercial Officer, stated, “We believe this important approval better positions BioSentry to rapidly become the standard of care post-lung biopsy. As the practice of diagnostic lung biopsies continues to evolve, we are dedicated to advancing the use of BioSentry to provide clinicians with the significant clinical and economic benefits of this one-of-a-kind sealant device following lung biopsy. Improved access to this technology will help physicians prevent patient complications and the associated cost of additional interventions with a straightforward, two minute procedure.”