BrosMed Announced CE MDR Approval of New Generation PTA SC Balloon Dilatation Catheters
Release time:
2024-05-27
May 27, 2024 — BrosMed announced that it has received certification under the European Medical Device Regulation (MDR) for its new-generation PTA SC Balloon Dilatation Catheters, marketed under the brand names Polux™ Pro 014, Minerva™ Pro 018, and Atropos™ Pro 035.
May 27, 2024 — BrosMed announced that it has received certification under the European Medical Device Regulation (MDR) for its new-generation PTA SC Balloon Dilatation Catheters, marketed under the brand names Polux™ Pro 014, Minerva™ Pro 018, and Atropos™ Pro 035.
BrosMed’s new-generation PTA SC Balloon Dilatation Catheters are designed for the treatment of symptomatic peripheral artery disease and are intended to restore the patency of indicated vessel lumens. The indicated vessels include the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as native or synthetic arteriovenous dialysis fistulas.
The new-generation PTA SC balloon series offers 2,123 size options to meet diverse clinical needs. The portfolio covers balloon diameters from 1.0 mm to 12.0 mm, balloon lengths from 10 mm to 300 mm, and shaft lengths from 40 cm to 200 cm. It is compatible with all three major guidewire systems: 0.014”, 0.018”, and 0.035”.
Compared with the first-generation series, the new-generation PTA SC balloon series features a broader size portfolio, including longer balloon lengths from over 200 mm to 300 mm, 1.0 mm small-diameter options for occlusive lesions, and 200 cm shaft lengths to support radial access.
In addition, the new-generation PTA SC balloon series includes specially designed tapered balloons for the treatment of long diffuse lesions in the lower limbs. To better match arterial anatomy, the 200–300 mm long balloon lengths feature a gradual reduction in balloon diameter from the proximal to the distal end, which is intended to help minimize vessel trauma while reducing the risk of over-dilatation and dissection. By more precisely matching the diameter of different vessel segments, the tapered balloon design may help improve procedural efficiency.
To enhance visualization, balloons with lengths of 200 mm or longer are equipped with four radiopaque marker bands: two middle markers, one proximal marker, and one distal marker.
Combining excellent crossability, strong pushability, and optimized deliverability, the new-generation PTA SC balloon series inherits the outstanding balloon performance of the first-generation series while expanding the product matrix with more size options and tapered balloon designs.
The launch of the new-generation PTA SC balloon series in Europe is expected to mark a new phase in BrosMed’s global peripheral vascular intervention business.
For more information about BrosMed’s new-generation PTA SC balloon series, please visit the BrosMed website or contact us via email at Sales@brosmed.com.
Join Us!
Please fill out this form and we will get in touch within 24 hours.
* Note: Please be sure to fill in the information accurately and keep the communication unblocked. We will get in touch with you as soon as possible.
More news
BrosMed Announces Canadian Approval of RevoEdge™ High-Pressure Cutting Balloon
BrosMed Medical today announced Canadian regulatory approval of the RevoEdge™ High-Pressure Cutting Balloon Dilatation Catheter, expanding the company’s presence in North America and marking another milestone in the global commercialization of its specialty coronary portfolio.
2026-09-14
BrosMed Announced CE MDR Approval of VascuGlide™ Microcatheter System
June 15, 2026-BrosMed is pleased to announce that the VascuGlide™ Microcatheter System has received CE MDR certification, marking another significant milestone in the company's commitment to advancing peripheral intervention solutions.
2026-06-18
