BrosMed Receives FDA 510(k) Clearance for Next Generation PTA SC Balloon Dilatation Catheters
Release time:
2025-03-03
March 3, 2025 – BrosMed is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Generation PTA SC Balloon Dilatation Catheters, including the Parafleet™ SC 014, Parafleet™ SC 018, and Parafleet™ SC 035 models.
These state-of-the-art PTA SC Balloon Dilatation Catheters are designed for the treatment of symptomatic peripheral artery disease (PAD), with a focus on restoring vessel lumen patency across various arteries, including the iliac, femoral, iliofemoral, popliteal, infrapopliteal, renal arteries, and native or synthetic arteriovenous dialysis fistulas.
The Next Generation PTA SC balloon series offers a versatile portfolio, with over 2,000 configurations tailored to meet diverse clinical needs. The balloons are available in diameters ranging from Ø1.25mm to Ø12.0mm, lengths from 10mm to 300mm, and shaft lengths between 40cm and 200cm. Additionally, the series is compatible with all three guidewire systems: 0.014”, 0.018”, and 0.035”. Compared to the first generation, the new PTA balloon series includes an expanded size range, featuring longer balloon lengths (up to 300mm), smaller Ø1.25mm sizes for occlusive lesions, and longer 200cm shaft lengths for radial access.
One of the key innovations in this new series is the introduction of specially designed conical balloons, optimized for the treatment of long, diffuse lesions in the lower limbs. For balloon lengths of 200mm to 300mm, the diameter gradually tapers from the proximal to the distal end. This design minimizes vessel trauma, reduces the risk of over-dilatation and dissection, and improves the overall safety and efficacy of the procedure.
To further enhance procedural visibility, balloons measuring ≥200mm in length feature four strategically placed marker bands: dual middle markers, a proximal marker, and a distal marker. This improved marking system ensures precise placement during treatment. The Next Generation PTA balloon series retains the superior crossability, pushability, and deliverability of the first-generation balloons, while offering expanded sizes and tapered balloons for more precise, tailored treatments.
“The launch of BrosMed’s Next Generation PTA Balloon series in the United States represents a significant milestone in the company’s growth strategy within the global peripheral vascular intervention market”, comments Scott J Addonizio, BrosMed’s Chief Operation Officer. “This innovative product line is poised to drive improvements in patient outcomes and further expand BrosMed’s market presence worldwide”.
About BrosMed
BrosMed specializes in the research, development, manufacturing, and global distribution of interventional technologies and products for complex vascular diseases. As a leading multinational group in the field of intravascular interventional medical devices, BrosMed offers over 40 product series and holds more than 600 product registration certificates globally. Our product range spans cardiovascular intervention, peripheral intervention, vascular access, neurovascular intervention, and interventional accessories, with sales in over 100 countries and regions.
Guided by our mission, "Technologies Embrace Life," BrosMed integrates medical and engineering expertise on a global scale, fostering open innovation through collaborations with industry, academia, and research institutions. We are committed to delivering safe, effective, high-quality, and innovative interventional solutions to healthcare professionals and patients around the world.
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