Brosmed Artimes™ Pro receives FDA Clearance for Treating Chronic Total Occlusions (CTO) in PTCA Intervention
Guangdong ,China [May 24 , 2021] – Brosmed Ltd. today announced that she has received a 510(k) clearance from the U.S. Food & Drug Administration for its Artimes™ Pro PTCA balloon catheter.
Artimes™ Pro is a novel PTCA semi-compliant rapid-exchange balloon dilatation catheter manufactured with specific features to facilitate complex coronary interventions. Its soft and laser-welded distal tip with an entry profile of 0.016” for the 1.00 mm and 1.25 mm, favor the deep engagement in the tight lesions or the CTO micro channels with a smooth a-traumatic lesion entry. Moreover, a novel balloon material ensures a low wrapping profile. The distal shaft coating Slider™, a biocompatible, hydrophilic, lubricious coating of the distal balloon base up to the rapid-exchange port, is another feature that improves trackability of the device across long, tortuous, and calcified lesions.
The seamless single-tube transition to the hypotube improves pushability allowing for superior force transmission without any loss during navigation.
These characteristics make the device truly competitive, in terms of penetration power, crossing profile, and pushability, with the best available CTO balloons.
BrosMed Medical is constantly expanding the product portfolio in the field of coronary angioplasty. The Artimes™ ( K141025, 1.5-4.0 mm) balloon portfolio has been sold in United States since 2015 and distributed in more than 50 countries around the world. Artimes™ Pro is a significant new addition to the CTO toolbox for tackling complex lesions in the USA market.
About BrosMed Medical
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.
Learn more about Brosmed at http://www.brosmed.com