New Hope for Limb Salvage: Serranator Data Shows Breakthrough in Treating High-Risk Arteries

WAYNE, PA – April 28, 2026 – For patients with the most severe form of peripheral artery disease, the path often ends in amputation. But a newly published study offers significant new hope, demonstrating that a novel device can safely and effectively treat the notoriously difficult arteries below the ankle, a critical battleground in the fight to save limbs.

Cagent Vascular, a medical technology company focused on endovascular solutions, has announced landmark peer-reviewed data for its Serranator® PTA Serration Balloon Catheter. Published in the prestigious Journal of Endovascular Therapy, the study confirms the device's ability to restore blood flow in patients with chronic limb-threatening ischemia (CLTI), a condition where blocked arteries in the lower legs threaten the viability of the foot and can lead to non-healing wounds, gangrene, and ultimately, limb loss.

The Clinical Challenge of the 'Desert Foot'

CLTI represents the end-stage of peripheral artery disease, affecting millions of people worldwide. The disease is particularly devastating when it strikes the small, delicate pedal arteries below the ankle, an area clinicians sometimes refer to as the "desert foot" due to the lack of effective treatment options. These inframalleolar vessels, often no wider than a few millimeters, are frequently hardened with severe calcium deposits, making them resistant to traditional treatments.

Standard angioplasty, which uses a plain balloon to push plaque aside, often fails in this challenging anatomy. The high pressures required to crack the calcified plaque can cause uncontrolled tearing and trauma to the vessel wall, leading to dissections that restrict blood flow or immediate recoil where the vessel snaps back to its narrowed state. These limitations have historically left physicians with few tools and patients with a grim prognosis, where amputation becomes a likely outcome.

“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, a vascular surgeon at Hartford HealthCare and the study's principal investigator. The challenge has not been a lack of will to treat, but a lack of tools that can perform safely and effectively in such a fragile environment.

A Serrated Solution for Calcified Arteries

The investigator-initiated study, led by Dr. Gifford, retrospectively evaluated 45 CLTI patients across multiple institutions. It stands as the largest published case series for a specialty technology in these below-the-ankle vessels. The results demonstrate a significant leap forward in capability.

Instead of relying on brute force, the Serranator utilizes a technology called Serration Remodeling Therapy™ (SRT). The device's balloon is embedded with three or four external, stainless steel micro-serrations. When inflated, these serrations apply highly concentrated, focused force—up to 1,000 times that of a standard balloon—to create controlled, linear micro-fissures in the hardened plaque. This unique mechanism allows the vessel to expand predictably and safely at modest inflation pressures of just 6 atmospheres on average.

The clinical outcomes from the study were compelling. Technical success, defined as achieving less than 50% residual narrowing, was accomplished in 93.3% of cases. Even more impressively, 82.2% of patients achieved less than 30% residual stenosis, indicating a wide-open channel for blood flow. The safety profile was equally strong, with a 93.3% freedom from vessel injury and, critically, no instances of vessel perforation or distal embolization, where plaque debris breaks off and travels downstream.

These immediate procedural successes translated into durable patient outcomes. At six months, 93.3% of patients were free from major amputation, and an identical percentage avoided a clinically-driven re-intervention on the treated lesion. Furthermore, the restored blood flow had a profound impact on wound healing, a primary goal of CLTI treatment. Nearly half of the patients (48.7%) achieved complete wound healing, with a total of 79.5% seeing their wounds either heal completely or improve. “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,” Dr. Gifford noted.

Paving the Way: Innovation Meets Reimbursement

The publication of this robust clinical data is strategically timed, coinciding with a major shift in the healthcare reimbursement landscape. Recognizing the unique complexity and resources required for below-the-ankle procedures, new dedicated CPT codes for inframalleolar interventions are set to become effective in January 2026. Historically, the lack of specific billing codes has been a barrier to the adoption of advanced techniques, making it financially challenging for hospitals and physicians to perform these limb-saving procedures.

The establishment of a clear reimbursement pathway is expected to unlock greater access to care and incentivize the use of effective technologies. “With new CPT codes now recognizing inframalleolar interventions as distinct procedures, we believe we are uniquely positioned to support physicians in this space,” said Paul Wilson, Cagent Vascular's Chief Commercial Officer. “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.”

This synergy of proven clinical efficacy and favorable economics could significantly accelerate the adoption of advanced pedal artery interventions, fundamentally changing the treatment paradigm for CLTI.

A New Standard of Care on the Horizon?

Experts see the Serranator not only as a primary treatment but also as a critical vessel preparation tool that enhances the effectiveness of other therapies, such as drug-coated balloons (DCBs). By creating a well-expanded vessel with minimal trauma, SRT can create an ideal environment for drugs designed to prevent re-narrowing to work effectively.

“The issue has not been a lack of intent to treat, but rather the difficulty of delivering therapy safely and effectively in this anatomy,” stated Dr. Peter Schneider, a vascular surgeon and Chief Medical Advisor for Cagent Vascular. “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.”

Building on this momentum, Cagent Vascular has already initiated the POINT FORCE observational registry, a large-scale study that will enroll at least 500 patients across 30 U.S. centers. This registry will gather real-world data on the Serranator's performance across the full spectrum of peripheral artery disease, further solidifying its role in modern vascular care. For the countless patients facing the devastating prospect of amputation, this combination of engineering innovation, strong clinical data, and a clear path to adoption represents a powerful new front in the battle to save limbs.