Healthcare Industry News:  chest tube 

Devices Regulatory

 News Release - May 23, 2016

Surgical Specialties Corporation Announces Approval of Expanded Use for BioSentry(TM) Track Sealant System in Europe

BRAINTREE, Mass., May 23, 2016 -- (Healthcare Sales & Marketing Network) -- Surgical Specialties Corporation (Surgical Specialties), a leading provider of branded, private label, and OEM medical devices for advanced surgery, wound closure, ophthalmology, and radiology announced today 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. To­mas 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."

About the BioSentry™ Tract Sealant System

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.

1. Zaetta JM, Licht MO, FisherJS, Avelar RL, et al. A Lung Biopsy Tract Plug for Reduction of Postbiopsy Pneumothorax and Other Complications: Results of a Prospective, Multicenter, Randomized, Controlled Clinical Study. J Vasc Interv Radiol 2010; 21:1235–1243

About Surgical Specialties Corporation

Surgical Specialties Corporation has developed and manufactured branded, private label, and OEM surgical instruments for over 40 years. Surgical Specialties Corporation offers one of the most comprehensive portfolios of blades and sutures available, including innovative products such as the Quill™ Knotless Tissue-Closure Device. Headquartered in Braintree, MA, Surgical Specialties Corporation devotes itself to exceeding the needs of the specialty surgery market, having trusted partnerships within dental, ophthalmic, plastic surgery, dermatology, orthopedics, urology, microsurgery, veterinary and trauma specialties. Visit us at www.surgicalspecialties.com and www.biosentrysystem.com


Source: Surgical Specialties Corp

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