March 21, 2023- BrosMed today announced that it receives European Medical Device Regulation (MDR) certification for Tiche™ 0.035” High Pressure PTA Balloon Dilatation Catheter which is designed for the treatment of severely calcified peripheral vascular disease and challenging AV cases. It is the first MDR certificate of BrosMed and also a successful conformity assessment which set a precedent for the future.
Following receiving FDA 510(k) clearance for Tiche™ in July 2022, the newly-granted CE Mark approval enables BrosMed Medical to accelerate business expansion in Europe.
Combining several technologies innovatively, Tiche™ has been developed to tackle physicians’ needs for an ultra-high-pressure balloon catheter in full range of sizes. The patented microcrystalline grid balloon technology is facilitated to provide high-pressure, non-compliant dilatation which concentrates force on the lesion and reduces the risk of overexpanding the vessel in a low-profile balloon. The twin layer balloon construction offers a rated burst pressure up to 24 atm. Additionally, the dual lumen shaft design will achieve rapid deflation time.
Tiche™ is available in a great variety of balloon diameters from 3.0 to 12.0mm, with usable shaft lengths of 40cm, 75cm, 120cm and 135cm to meet the clinical needs.
It is believed that the release of Tiche™ 0.035” PTA Balloon Dilatation Catheter in Europe will mark a new phase in BrosMed’s peripheral vascular intervention business globally. BrosMed is determined to develop innovative medical devices to enhance its contribution to patients worldwide.
For more information about Tiche™, please visit BrosMed website or contact us via e-mail: Sales@brosmed.com.