BrosMed Announced CE MDR Approval of Tiche™ 0.035”High Pressure PTA Balloon Dilatation Catheter
Release time:
2023-03-21
March 21, 2023 — BrosMed today announced that it has received certification under the European Medical Device Regulation (MDR) for its Tiche™ 0.035” High Pressure PTA Balloon Dilatation Catheter, which is designed for the treatment of severely calcified peripheral vascular disease and challenging arteriovenous (AV) access cases.
March 21, 2023 — BrosMed today announced that it has received certification under the European Medical Device Regulation (MDR) for its Tiche™ 0.035” High Pressure PTA Balloon Dilatation Catheter, which is designed for the treatment of severely calcified peripheral vascular disease and challenging arteriovenous (AV) access cases. This marks BrosMed’s first MDR certificate and represents a successful conformity assessment, setting a strong precedent for future regulatory submissions.
Following the FDA 510(k) clearance granted for Tiche™ in July 2022, the newly obtained CE Mark approval enables BrosMed Medical to further accelerate its business expansion in Europe.
Tiche™ has been developed through the innovative integration of several advanced technologies to meet physicians’ needs for an ultra-high-pressure balloon catheter available in a full range of sizes. Its patented microcrystalline grid balloon technology is designed to provide high-pressure, non-compliant dilatation by concentrating force on the lesion while reducing the risk of vessel overexpansion within a low-profile balloon design. The dual-layer balloon structure offers a rated burst pressure of up to 24 atm. In addition, the dual-lumen shaft design helps achieve a short deflation time.
Tiche™ is available in a wide range of balloon diameters from 3.0 mm to 12.0 mm, with usable shaft lengths of 40 cm, 75 cm, 120 cm, and 135 cm to meet diverse clinical needs.
The launch of the Tiche™ 0.035” PTA Balloon Dilatation Catheter in Europe is expected to mark a new phase in BrosMed’s global peripheral vascular intervention business. BrosMed remains committed to developing innovative medical devices and making greater contributions to patients worldwide.
For more information about Tiche™, please visit the BrosMed website or contact us via email at Sales@brosmed.com.
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