BrosMed Announces FDA 510(k) Clearance and Launch of Additional Configurations of Apollo™ NC PTCA Balloon Catheters in the United States and North America Market
Release time:
2016-08-08
BrosMed Announces FDA 510(k) Clearance and Launch of Additional Configurations of Apollo™ NC PTCA Balloon Catheters in the United States and North America Market
BrosMed Announces FDA 510(k) Clearance and Launch of Additional Configurations of Apollo™ NC PTCA Balloon Catheters in the United States and North America Market.
August 8th, 2016—Following the Apollo™ NC PTCA FDA 510(k) clearance in October 2014, BrosMed announced FDA 510(k) clearance and the launch of its additional configurations of Apollo™ NC PTCA Balloon Catheters, which are now approved and ready for sale in the United States of America and the North America market for 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 localized stenotic lesions of the coronary arteries.
According to the company, the new 6mm, 20mm, 22mm, 25mm and 30mm balloon lengths, with balloon diameters from 2.0mm to 5.0mm, are added and approved by the FDA along with the previously approved 8mm, 10mm, 12mm, 15mm and 18mm lengths. The new configurations of non-compliant Apollo™ will enhance the company’s current sales in the United States and the North America market.
Please contact our regional distributors and/or our sales team at sales@brosmed.com or cs@brosmed.eu or call our office at +31 850 14 09 01 for more product details.
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.
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