Surgical Specialties, a 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 events.
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.
“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,” said Brennan Marilla, CCO of Surgical Specialties. “Improved access to this technology will help physicians prevent patient complications and the associated cost of additional interventions with a straightforward, two minute procedure.”