Surgical Specialties Corporation, a leading provider of branded, private label, and OEM medical devices for advanced surgery, wound closure, ophthalmology, and radiology announced approval for expanded European labeling for its BioSentry Track sealant system.
This approval expands the number of patients that can benefit from this technology now that it can be used with a larger 17 gauge biopsy system. This important change allows a significantly greater number of percutaneous transthoracic lung biopsy procedures to be able to use BioSentry™, which is proven to reduce the risk of pneumothorax and subsequent adverse events1.
Lung biopsies are a critical diagnostic step for clinicians to determine specific treatments for patients, and with more tumor specific therapies available, there is a growing desire for larger tissue samples. However, there is concern that larger needles may increase the incidence of pneumothorax.
Prof. Dr. med. To¬mas Vogl from Frankfurt University, Germany said, "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™."
Brennan Marilla, Chief Commercial Officer of Surgical Specialties Corporation commented, "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."
BioSentry™ System delivers a hydrogel plug placed into the lung along the biopsy needle tract, which expands to prevent air from leaking out and creating a pneumothorax, which is the only medical device with CE Mark approval for this indication in Europe.
BioSentry™ offers clinicians and patients a new therapy option that has demonstrated superior clinical outcomes to the current standard of care for this procedure with the 19 gauge biopsy system, and now with a 17 gauge biopsy system.
In a prospective, randomized, multicenter clinical trial of 339 patients, BioSentry™ was found to significantly reduce the risk of pneumothorax by a relative risk reduction of greater than 50%1. Pneumothorax can require additional treatment costs and interventions including chest tube placements, additional radiographs, inpatient admission or emergency room visits, delayed time to ambulation and hospital discharge.
The BioSentry™ trial also demonstrated relative risk reduction of additional radiographs by 44%, chest tube placements by 67% and post-procedure admissions by 35%. Pneumothorax is the most common cost and care-intensive complication of CT-guided percutaneous lung biopsy, occurring in 15-42% of patients.