Bovie Medical Corporation Announces 510K Submission To The FDA For Its BOSS Soft Tissue Coagulation Device

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Jul 2009 - 3:00 PDT

email to a friend   printer friendly   opinions  

Bovie Medical Corporation (the "Company") (NYSE-AMEX Symbol: BVX), a manufacturer and marketer of electrosurgical products, announced a 510K submission to the FDA seeking pre-market clearance for Bovie's BOSS for surgical applications where soft tissue bipolar coagulation is desired. The BOSS is the latest generation device based on Bovie's saline enhanced sintered steel technology.

The BOSS delivers RF energy simultaneously with saline to perform coagulation of soft tissue and bone, with minimal smoke, charring and sticking of tissue as well as reduced blood loss. Saline enhanced surgeries reduce operating time while improving post-operative outcomes and shortens recovery time.

The BOSS will primarily be targeted towards orthopedic hip and knee reconstruction surgeries, which are significant markets, with over 1.3 million procedures performed in the United States annually. These procedures represent large and growing markets due to a more active and aging population. The worldwide market is expected to exceed $500 million in 2009.

Andrew Makrides, president of Bovie, stated, "In today's economic environment, where controlling medical costs is important, the BOSS technology meets the needs of patients, surgeons and hospitals. Reduced blood loss, shortened operating and recovery time makes the BOSS a technology product that targets a large and growing market."

For further information about the Company's current and new products, please refer to the Investor Relations section of Bovie's website http://www.boviemedical.com.

Source
Bovie Medical Corporation

• Additional
• References
• Citations