BrosMed Announces FDA 510(k) Clearance and Launch of Additonal Configurations Apollo™ NC PTCA Balloon Catheters in Unitied States and North Amercia Market
August 8th, 2016—Following the Apollo™ NC PTCA FDA 510(k) clearance in October 2014, BrosMed announced FDA 510(k) clearance and launch its additional configurations Apollo™ NC PTCA Balloon Catheters which is now approved and ready for sale in the United States of America and the North America market for the interventional cardiovascular use. Apollo™ Non-Compliant 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.
Accroding to the company, the new 6mm, 20mm, 22mm, 25mm and 30mm balloon lengths of balloon diameter 2.0mm to 5.0mm are added and approved by FDA along with previous proved 8mm, 10mm, 12mm, 15mm and 18mm. The new configurations of non-compliant Apollo™ will enhance company’s current sales in the Unitied States and the North Amercia market.
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.
BrosMed Medical product portfolio consist of, Artimes™ PTCA, Apollo™ NC PTCA, Atropos™ 0.035 PTA, Minerva™ 0.018 PTA, Polux™ 0.014 PTA, Hermes™ NC 0.035 PTA, Achilles™ NC 0.018 PTA, Castor™ NC 0.014 PTA, Conger™ Hytrophilic coated wire and series of accessories.