BrosMed Receives FDA Clearance for Tiche™ 0.035” Super High Pressure PTA Balloon Dilatation Catheter
Guangdong, China [July 20, 2022] – BrosMed Medical announced its Tiche™ 0.035” PTA Balloon Dilatation Catheter has received the 510(k) clearance from the U.S. Food & Drug Administration.
Tiche™ is a highly deliverable 0.035-inch percutaneous transluminal angioplasty (PTA) catheter designed for a wide range of peripheral angioplasty procedures. BrosMed plans to launch the product in the United States firstly, it is proposed to get CE certificate soon.
BrosMed developed Tiche™ according to the clinical needs for a low-profile, superior high pressure balloon catheter in full range of sizes. The patented microcrystalline grid balloon technology is facilitate 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 of up to 24 atmospheres and is the only 7 x 200 mm balloon compatible with a 5 French introducer sheath. Additionally, The dual lumen shaft design will achieves rapid deflation time.
With Balloon diameters varies from 3.0mm to 12.0mm, and usable shaft lengths 40cm, 75cm, 120cm and 135cm, Tiche™ is equipped with 278 sizes to meet various clinical demands.
Tiche™ High Pressure PTA Balloon Dilatation Catheter is recommended for PTA of the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for stent dilatation post-deployment in the peripheral vasculature.
The launch of Tiche™ 0.035” PTA Balloon Dilatation Catheter marks a new stage of BrosMed technology level for PTA balloons. For more product information of Tiche™, you can search BrosMed website www.brosmed.com or contact us via e-mail: Sales@brosmed.com.