Cagent Vascular’s Serranator PTA Device Studied for Pedal Interventions in Patients With CLTI

April 29, 2026—Cagent Vascular announced the publication of data demonstrating the safety and efficacy of the company’s Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter in pedal (inframalleolar) interventions for patients with chronic limb-threatening ischemia (CLTI).

Edward Gifford, MD, et al published the study findings online in the Journal of Endovascular Therapy. The investigator-initiated, multicenter, retrospective study was led by Dr. Gifford, who is a vascular surgeon at Hartford HealthCare in Hartford, Connecticut.

According to the company, the investigators evaluated 45 patients who underwent Serration Remodeling Therapy (SRT) within the pedal vasculature for CLTI, which demonstrated strong results across multiple endpoints.

As summarized in Cagent Vascular’s press release, technical success (defined as < 50% residual stenosis) was achieved in 93.3% of cases, with 82.2% of patients achieving < 30% residual stenosis. Additionally, freedom from vessel injury was 93.3%, with no instances of vessel perforation or distal embolization.

At 6 months, both the freedom from major amputation and the freedom from clinically driven target lesion revascularization were 93.3%. Complete wound healing was achieved by 48.7% of patients 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,” commented Dr. Gifford in Cagent Vascular’s press release. “These results demonstrate that SRT 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.”

Dr. Gifford added, “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.”

The company noted that publication of this study coincides with the new dedicated CPT codes established for inframalleolar procedure becoming effective in January 2026, providing a clear reimbursement pathway for pedal revascularization.