Saving Limbs Where Others Stop: Cagent Vascular Announces Landmark Peer-Reviewed Data Demonstrating Safety and Efficacy of Serration Remodeling Therapy™ in the Most Challenging Arteries Below-the-Ankle

Largest published series of specialty technology use in inframalleolar vessels shows 93.3% technical success, 93.3% freedom from clinically-driven target lesion revascularization, and nearly 80% wound healing or improvement

WAYNE, Pa.--(BUSINESS WIRE)--Cagent Vascular, a leader in innovative endovascular technologies, today announced the publication of a peer-reviewed study in the Journal of Endovascular Therapy (JEVT) demonstrating the safety and efficacy of the Serranator^® PTA Serration Balloon Catheter in pedal (inframalleolar) interventions for patients with chronic limb-threatening ischemia (CLTI).

The investigator-initiated, multi-institutional, retrospective study, led by Dr. Edward Gifford, vascular surgeon at Hartford HealthCare in Hartford, CT, evaluated 45 patients who underwent Serration Remodeling Therapy^™ (SRT) within the pedal vasculature for CLTI. This represents the largest published clinical case series examining the use of a specialty technology in inframalleolar vessels, which are considered a challenging anatomy to access and safely treat. Safe and effective treatment options for these patients have historically been limited.

The study demonstrated strong results across multiple endpoints. Technical success, defined as less than 50% residual stenosis, was achieved in 93.3% of cases, with 82.2% of patients achieving less than 30% residual stenosis. Freedom from vessel injury was 93.3%, with no instances of vessel perforation or distal embolization. At six months, freedom from major amputation and freedom from clinically-driven target lesion revascularization were both 93.3%. Nearly half of patients (48.7%) achieved complete wound healing at a median follow-up of 163 days, with a total wound healing or improvement rate of 79.5%.

“Patients with pedal artery occlusive disease represent some of the most complex cases we encounter, with historically high rates of limb loss,” said Dr. Edward Gifford, principal investigator of the study. “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.”

Serration Remodeling Therapy (SRT) is a novel approach to optimizing luminal gain by gently remodeling the internal elastic lamina through creating a line of weakness to reduce recoil and support durable outcomes. In pedal interventions, the Serranator was delivered in diameters ranging from 2.5 mm to 3.5 mm, with the unique serration mechanism directing concentrated force at calcific burden, despite modest inflation pressures of approximately 6 atmospheres. Notably, 57.8% of patients in the study had severe pedal vessel calcification, underscoring the ability of the technology to perform in challenging anatomy.

The publication of this study coincides with an important shift in the reimbursement landscape for pedal interventions. Effective January 2026, new dedicated CPT codes have been established specifically for inframalleolar procedures, recognizing the distinct clinical complexity and resource requirements of below-the-ankle interventions. These new codes provide physicians with a clear reimbursement pathway for pedal revascularization, an area that has historically lacked dedicated coding recognition.

“This publication adds to the growing body of clinical evidence supporting Serration Remodeling Therapy across the full spectrum of peripheral artery disease,” said Paul Wilson, Chief Commercial Officer. “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.”

“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,” said Dr. Peter Schneider, vascular surgeon, Chief Medical Advisor and Co-Founder of Cagent Vascular. “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.”

The full study is available online in the Journal of Endovascular Therapy. For more information about the Serranator^® PTA Serration Balloon Catheter, please visit cagentvascular.com.