BrosMed Announces FDA 510(k) Clearance and Launch for Artimes™ Balloon Dilatation Catheter in the North America and Global Market
September 17, 2014— Following the CE approval and launch Artimes™ Balloon Dilatation Catheter, BrosMed announced FDA 510(k) clearance for Artimes™ Balloon Dilatation Catheter which is now approved and ready for sale in the United States of America and the North America market for the interventional cardiovascular use. Artimes™ rapid exchange PTCA balloon catheter is intended to be used for percutaneous transluminal coronary angioplasty (PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.
“It is absolutely important milestone of BrosMed accomplished in 2014. The FDA 510(k) clearance and launch of Artimes™ Balloon Catheter in the United States of America proved one more time that BrosMed products excellent performance and outstanding quality. The FDA approval definitely helps us to expand ourselves from current European markets to the North America market and later penetrate global market.” said by Stephen Lee, VP of Operation & Regulatory Affairs of the company.
About BrosMed Medical
BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution.
BrosMed Medical develops, manufactures and markets medical devices primarily used by interventional cardiologists, radiologists and vascular surgeons in angioplasty procedures and other minimal invasive devices.
We provide solutions to our customers through innovative design, effective supply chain management, world-class manufacturing, and flexible channels of distribution and through the development or acquisition of innovative technologies.