BrosMed Announced CE MDR Approval of New Generation PTA SC Balloon Dilatation Catheters

May 27, 2024- BrosMed announced that it receives European Medical Device Regulation (MDR) certification for the New Generation PTA SC Balloon Dilatation Catheters (Brand Name: Polux™ Pro 014, Minerva™ Pro 018 and Atropos™ Pro 035).

BrosMed New Generation PTA SC Balloon Dilatation Catheters are designed for the treatment of symptomatic peripheral artery disease, aimed to restore the patency of indicated vessel lumen. These indicated vessels include iliac, femoral, iliofemoral, popliteal, infrapopliteal, renal arteries, and native or synthetic arteriovenous dialysis fistulae.

The New Generation PTA SC balloon series have 2123 sizes available to meet diverse clinical needs. Its balloon diameter ranges from Ø1.0 – 12.0mm, balloon length varies from 10 – 300mm, and shaft length from 40 to 200cm. It is compatible for all the three guidewire systems (0.014”, 0.018” and 0.035”). Compared to the first-generation, the New Generation PTA balloon series has a broader size portfolio. It covered more sizes, especially for longer balloon lengths over 200mm to 300mm, Ø1.0 small sizes for occlusive lesions and longer shaft length 200cm for radial access.

Moreover, the New Generation PTA balloon series added specially designed tapered balloons for effective long diffuse lesion treatment in lower limbs. To match the arterial anatomy, there is a setting of balloon diameter reduction from proximal to distal end for the 200-300 mm long balloon lengths, which potentially minimizing vessel trauma while avoiding over-dilatation and dissections. Through safe and efficient dilatation by more precisely matching the size of each part of the vessel, it can increase the efficiency of the procedure.

In order to enhance visualization, there are four adjacent marker bands on ≥200mm length balloons: dual middle markers, one proximal marker and one distal marker respectively.

Combined exceptional crossability, superb pushability and optimal deliverability, the New Generation PTA series inherits the excellent balloon performance of the first-generation and adds more sizes and tapered balloons to its matrix.

It is believed that the release of New Generation PTA balloon series in Europe will mark a new phase in BrosMed’s peripheral vascular intervention business globally.

For more information about BrosMed New Generation PTA balloon series, please visit BrosMed website or contact us via e-mail: Sales@brosmed.com.