WAYNE, PA — A peer-reviewed study of Cagent Vascular’s Serranator catheter reported high procedural success and wound-healing rates in patients with chronic limb-threatening ischemia, findings that arrive as new reimbursement codes expand the commercial market for below-the-ankle vascular interventions.
The retrospective study evaluated 45 patients treated with the company’s Serration Remodeling Therapy in inframalleolar, or pedal, arteries, an area of vascular intervention associated with elevated risks of limb loss, severe calcification, and procedural complications.
Cagent described the study as the largest published case series examining specialty-device use in inframalleolar vessels.
According to the study, technical success — defined as less than 50% residual stenosis — was achieved in 93.3% of procedures. Freedom from clinically driven target lesion revascularization and freedom from major amputation were also reported at 93.3% after six months.
Researchers reported no cases of vessel perforation or distal embolization. Nearly 80% of patients experienced wound healing or improvement, while 48.7% achieved complete wound healing at median follow-up of 163 days.
“Patients with pedal artery occlusive disease represent some of the most complex cases we encounter, with historically high rates of limb loss,” lead investigator Dr. Edward Gifford of Hartford HealthCare said in a statement.
The findings arrive as physicians and device makers seek improved treatment approaches for chronic limb-threatening ischemia, a severe form of peripheral artery disease that can lead to amputation when blood flow to the lower extremities becomes critically reduced.
The study found 57.8% of patients had severe pedal vessel calcification, a condition that can complicate endovascular procedures and limit treatment effectiveness.
The publication also coincides with reimbursement changes affecting below-the-ankle interventions. Beginning in January 2026, new CPT codes for inframalleolar procedures took effect, creating dedicated reimbursement pathways for pedal revascularization procedures.
Dr. Peter Schneider, Cagent’s co-founder and chief medical advisor, said the anatomy involved in pedal artery disease has historically limited the ability to safely deliver therapy in small, calcified vessels.
The Serranator catheter is designed to remodel arterial tissue during balloon angioplasty procedures in an effort to reduce vessel recoil and improve long-term blood flow outcomes.
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