Cagent Vascular Expands Serranator® Platform with Launch of 7.0 mm and 8.0 mm PTA Serration Balloon Catheters, Enhancing Treatment Options for Complex Peripheral Artery Disease
Cagent Vascular, a pioneering force in the development of next-generation endovascular solutions, has announced the commercial launch of two new diameters—7.0 mm and 8.0 mm—for its innovative Serranator® PTA Serration Balloon Catheter. This strategic expansion of the Serranator® product line marks a significant advancement in the treatment of peripheral artery disease (PAD), particularly in larger vessel territories such as the common and external iliac arteries, superficial femoral artery (SFA), and arteriovenous (AV) fistulas. By extending the reach of its proprietary serration technology to these critical anatomical regions, Cagent Vascular is empowering interventional cardiologists and vascular surgeons with a more versatile, predictable, and vessel-sparing tool for managing complex vascular pathologies.
The Serranator® PTA Serration Balloon Catheter represents a paradigm shift in percutaneous transluminal angioplasty (PTA). Unlike conventional balloon catheters that rely solely on radial force to dilate stenotic or occluded vessels—a process that can lead to vessel injury, dissection, and elastic recoil—the Serranator® integrates micro-engineered serration elements directly into the balloon surface. Upon inflation, these precision-formed serrations create multiple, controlled, longitudinal micro-incisions along the intimal and medial layers of the arterial wall. This unique mechanism enables uniform vessel expansion while significantly reducing the risk of barotrauma, the high-pressure injury often associated with standard angioplasty balloons.
The clinical benefits of this approach are multifaceted. By scoring the plaque and vessel wall in a controlled manner, the Serranator® facilitates more predictable luminal gain, minimizes the likelihood of flow-limiting dissections, and reduces acute vessel recoil—common challenges that can compromise procedural success and long-term patency. Moreover, the technology’s ability to achieve effective dilation at lower inflation pressures enhances patient safety and may reduce the need for adjunctive stenting, aligning with the growing preference for vessel preparation techniques that preserve future treatment options.
Until now, the Serranator® platform had been available in smaller diameters, primarily targeting infrapopliteal and mid-SFA lesions. The introduction of the 7.0 mm and 8.0 mm variants fills a critical gap in the interventional armamentarium, addressing a well-documented unmet need in the management of large-vessel PAD. Lesions in the iliac arteries and proximal SFA often involve heavily calcified, fibrotic, or long-segment disease that is notoriously resistant to conventional balloon angioplasty. These anatomical regions also present unique challenges due to their size, curvature, and proximity to critical branching vessels. The availability of larger Serranator® balloons now allows clinicians to apply the advantages of serration-based vessel preparation to these more proximal and complex territories.
Dr. Neil Poulsen, an interventional cardiologist at Clara Maass Medical Center in Belleville, New Jersey, has been an early adopter of the Serranator® technology and welcomed the new size offerings. “The addition of the 7.0 mm and 8.0 mm Serranator® balloons gives us new options for treating patients with large vessel peripheral artery disease,” Dr. Poulsen stated. “I’ve found serration technology to provide controlled, effective expansion with less vessel trauma and recoil compared to conventional angioplasty. Having these larger sizes available gives us a versatile tool that can be applied in real-world cases where options have historically been limited.”
His clinical experience underscores a broader trend in endovascular therapy: the shift toward precision-based, atraumatic vessel preparation. As PAD prevalence continues to rise—driven by aging populations, diabetes, and smoking—the demand for technologies that improve procedural outcomes while minimizing complications has never been greater. The Serranator®’s expansion into larger diameters positions it as a cornerstone in comprehensive PAD treatment strategies, bridging the gap between distal and proximal disease management.
With this launch, the Serranator® portfolio now spans a full continuum of vessel sizes—from below-the-knee (BTK) applications as small as 2.0 mm to the newly introduced 8.0 mm balloons for large iliac and AV fistula interventions. This breadth enables a single-platform approach across diverse anatomical territories, streamlining inventory for hospitals and enhancing procedural consistency for clinicians. Whether treating critical limb ischemia in tibial vessels or managing stenoses in dialysis access circuits, physicians can now rely on the same underlying serration principle, adapted to the specific diameter and compliance of the target vessel.
Paul Wilson, Chief Commercial Officer at Cagent Vascular, emphasized the company’s patient- and physician-centric development philosophy. “This milestone reflects our commitment to addressing unmet needs in peripheral vascular care,” Wilson said. “Physicians asked us for larger sizes, and we are proud to deliver solutions that continue to support both everyday and highly complex interventions.” The expansion, he noted, was driven by direct feedback from the interventional community, highlighting Cagent Vascular’s agile and responsive approach to product innovation.
The clinical implications of this launch extend beyond technical versatility. In the iliac arteries, for example, where stent placement has traditionally been common due to suboptimal results with plain old balloon angioplasty (POBA), the Serranator® offers a compelling alternative for vessel preparation that may defer or even eliminate the need for permanent implants. Similarly, in AV fistula interventions—where maintaining vessel integrity and minimizing trauma are paramount to preserving long-term access—the controlled scoring mechanism of the Serranator® may improve primary patency rates and reduce the frequency of repeat procedures.
Furthermore, the technology aligns with evolving reimbursement and value-based care models that incentivize durable, minimally invasive solutions. By potentially reducing stent usage, lowering complication rates, and improving procedural efficiency, the Serranator® platform may contribute to more cost-effective PAD management over the patient’s care continuum.
The 7.0 mm and 8.0 mm Serranator® PTA Serration Balloon Catheters are now commercially available across the United States. Cagent Vascular plans to support the rollout with targeted physician training programs, clinical data dissemination, and real-world evidence collection to further validate the technology’s impact in large-vessel applications.
As the field of endovascular therapy continues to evolve, innovations like the Serranator® exemplify the move toward smarter, more tailored interventions. By combining mechanical precision with physiological respect for vessel biology, Cagent Vascular is not only expanding its product line but also redefining what’s possible in the treatment of peripheral vascular disease. With the addition of these larger diameters, the Serranator® cements its role as a comprehensive, adaptable, and forward-looking solution for the full spectrum of PAD—from the smallest tibial branches to the largest iliac conduits.
