Advancing Limb Salvage: Cagent Vascular Reports Landmark Peer-Reviewed Evidence Supporting Serration Remodeling Therapy™ in Complex Below-the-Ankle Arteries
Cagent Vascular, a recognized innovator in endovascular device technologies, has announced the publication of new peer-reviewed clinical evidence in the Journal of Endovascular Therapy (JEVT) highlighting the safety and effectiveness of its Serranator® PTA Serration Balloon Catheter when used for pedal (inframalleolar) interventions in patients suffering from chronic limb-threatening ischemia (CLTI).
The study, conducted as an investigator-initiated, multi-institutional retrospective analysis, was led by Dr. Edward Gifford, a vascular surgeon at Hartford HealthCare in Hartford, Connecticut. It evaluated 45 patients who underwent Serration Remodeling Therapy™ (SRT) targeting the pedal vasculature—one of the most anatomically challenging regions in peripheral endovascular intervention. According to Cagent Vascular, this represents the largest published clinical case series to date focusing on the use of a specialized angioplasty technology in below-the-ankle vessels, a domain where treatment options have historically been limited due to vessel size, calcification burden, and elevated procedural risk.
Strong clinical outcomes in complex anatomy
The study demonstrated favorable outcomes across multiple safety and efficacy endpoints. Technical success, defined as achieving less than 50% residual stenosis, was reported in 93.3% of cases. Notably, 82.2% of patients achieved even more optimized results, with residual stenosis reduced to below 30%.
Safety outcomes were equally compelling. Freedom from vessel injury was observed in 93.3% of procedures, with no reported cases of vessel perforation or distal embolization. These findings are particularly significant given the fragile and highly calcified nature of inframalleolar vessels commonly affected in CLTI patients.
At six-month follow-up, both freedom from major amputation and freedom from clinically driven target lesion revascularization were reported at 93.3%. In addition, nearly half of the treated population (48.7%) achieved complete wound healing within a median period of 163 days. Overall, 79.5% of patients demonstrated either complete wound healing or measurable improvement, underscoring the clinical benefit of restored blood flow in promoting tissue recovery.
Clinical significance in limb-threatening disease
Dr. Edward Gifford emphasized the complexity of treating pedal artery disease, noting that these cases often represent the most advanced stage of peripheral vascular disease.
“Patients with pedal artery occlusive disease represent some of the most complex cases we encounter, with historically high rates of limb loss,” Dr. Gifford said. “These results demonstrate that Serration Remodeling Therapy with Serranator can be safely and effectively delivered in the below-the-ankle vasculature, achieving meaningful luminal gain at low inflation pressures, even in severely calcified vessels. The wound healing rates we observed were ahead of previously published studies on inframalleolar intervention, which is encouraging for this difficult-to-treat patient population.”
CLTI remains one of the most severe manifestations of peripheral artery disease, often leading to chronic wounds, infections, and in many cases, major amputations if blood flow cannot be restored. In this context, technologies capable of improving perfusion in small, calcified distal vessels are increasingly critical.
Mechanism of Serration Remodeling Therapy
Serration Remodeling Therapy (SRT), the proprietary mechanism behind the Serranator® device, is designed to enhance luminal gain through controlled mechanical modification of the vessel wall. Unlike conventional balloon angioplasty, which relies primarily on radial force, SRT creates micro-incisions in the internal elastic lamina. This controlled “serration” is intended to reduce vessel recoil and improve vessel compliance, thereby supporting more durable vessel patency.
In the study, the Serranator was used in balloon sizes ranging from 2.5 mm to 3.5 mm and operated at relatively low inflation pressures of approximately 6 atmospheres. Despite these modest pressures, the serration mechanism allowed targeted force delivery to calcified lesions, improving vessel expansion while minimizing trauma.
A notable aspect of the study population was the high prevalence of severe calcification, present in 57.8% of patients. Calcified lesions are among the most difficult to treat in peripheral interventions, often resisting expansion and contributing to procedural failure or early restenosis. The device’s ability to perform effectively in this setting was highlighted as a key advantage.
Reimbursement landscape supports clinical adoption
The publication of these findings comes at a time of significant change in the reimbursement environment for pedal interventions. Beginning in January 2026, new Current Procedural Terminology (CPT) codes will specifically recognize inframalleolar procedures as distinct clinical services.
These dedicated codes reflect growing acknowledgment of the complexity and resource intensity associated with below-the-ankle interventions. Historically, lack of specific coding has been a barrier to reimbursement, limiting widespread adoption of advanced technologies in this space.
Cagent Vascular believes this development will accelerate clinical adoption by providing physicians with clearer reimbursement pathways and formal recognition of pedal revascularization procedures as a distinct category of care.
Expanding role in peripheral artery disease treatment
According to Paul Wilson, Chief Commercial Officer at Cagent Vascular, the latest clinical data further validates the versatility of the Serranator platform across the spectrum of peripheral artery disease.
“This publication adds to the growing body of clinical evidence supporting Serration Remodeling Therapy across the full spectrum of peripheral artery disease,” Wilson stated. “With new CPT codes now recognizing inframalleolar interventions as distinct procedures, we believe we are uniquely positioned to support physicians in this space. From large iliac vessels to the smallest pedal arteries, the Serranator is demonstrating its versatility as a tool that physicians can rely on to deliver safe, effective results in some of the most challenging vascular beds.”
The company positions its technology as applicable across a wide range of vessel sizes, suggesting a unified approach to endovascular treatment that spans from proximal arterial disease to highly distal limb-threatening conditions.
Expert perspective on clinical challenges
Dr. Peter Schneider, vascular surgeon, Chief Medical Advisor, and Co-Founder of Cagent Vascular, emphasized the technical difficulty associated with pedal interventions.
“Pedal artery disease represents one of the most technically demanding areas in endovascular intervention, where small vessel size, severe calcification, and the risk of vessel injury make treatment particularly challenging,” Dr. Schneider said. “The issue has not been a lack of intent to treat, but rather the difficulty of delivering therapy safely and effectively in this anatomy. These results demonstrate that Serration Remodeling Therapy can be precisely delivered in below-the-ankle vessels, achieving meaningful luminal gain while maintaining a strong safety profile. For physicians, that combination of deliverability and control is critical in treating patients at high risk for limb loss.”
His remarks underscore a broader clinical need for tools that combine precision, safety, and effectiveness in small-caliber vessels where traditional angioplasty techniques may be limited.
The publication of this study in the Journal of Endovascular Therapy adds meaningful clinical evidence supporting the use of Serration Remodeling Therapy in the treatment of chronic limb-threatening ischemia, particularly in the challenging inframalleolar region. With strong technical success rates, high safety outcomes, and encouraging wound healing results, the findings suggest that Serranator® may play an important role in expanding treatment options for patients at risk of limb loss.
As reimbursement frameworks evolve and clinical evidence continues to grow, Cagent Vascular’s Serranator platform appears positioned to contribute significantly to the advancement of below-the-ankle endovascular therapies.
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