BrosMed’s Tiche 0.035-inch PTA Balloon Dilatation Catheter Approved in Europe

March 21, 2023—BrosMed, a medical device company based in Guangdong, China, announced that its Tiche 0.035-inch high-pressure percutaneous transluminal angioplasty (PTA) balloon dilatation catheter received CE Mark approval under the European Medical Device Regulation (MDR) certification process.

The Tiche PTA device is designed for the treatment of severely calcified peripheral vascular disease and challenging arteriovenous cases.

According to BrosMed, the Tiche innovatively combines several technologies to tackle physicians’ needs for an ultra-high-pressure balloon catheter in a full range of sizes.

Its microcrystalline grid balloon technology provides high-pressure, noncompliant dilatation that 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 allows rapid deflation time.

Tiche is available in balloon diameters from 3.0 to 12.0 mm, with usable shaft lengths of 40, 75, 120, and 135 cm.

The company noted that this is the first MDR certificate for BrosMed and enables the company to accelerate business expansion in Europe. In addition to CE Mark approval, the device received FDA 510(k) clearance for Tiche in July 2022.