Terumo's ROADSAVER™ Carotid Stent System: A Revolutionary Advance in Carotid Artery Treatment

Terumo Interventional Systems (TIS), a prominent division of Terumo Corporation, has unveiled its groundbreaking ROADSAVER™ Carotid Stent System, marking a significant milestone in the management of carotid artery stenosis. This new stent system, which has received FDA approval, is designed to enhance clinical outcomes for patients at heightened risk of complications following carotid endarterectomy procedures.

A Dual-Layer Innovation

The ROADSAVER Stent System distinguishes itself as the only carotid artery stenting device featuring a dual-layer micromesh structure. This design combines the benefits of a closed-cell stent with the enhanced flexibility typically seen in open-cell designs. Such an innovation ensures improved wall apposition and flexibility in navigating complex arterial anatomies.

One of the standout features of this system is its capability to contain plaque against the vessel wall, effectively preventing plaque protrusion, which can lead to embolization during procedures. Dr. Michael J. Martinelli, Chief Medical Officer of Terumo Medical Corporation, asserts that the inner micromesh layer boasts a pore size four times smaller than that of any current carotid stent, thus offering sustained embolic protection and setting a new standard in carotid artery procedure technology.

Sizes and Design

The ROADSAVER Stent System is available in sizes ranging from 5 mm to 10 mm in width, with lengths spanning from 22 mm to 47 mm. It features a rapid-exchange shaft measuring 143 cm and embodies a low-profile 5Fr design, which significantly enhances its crossability and maneuverability through the vascular system. It also includes essential characteristics like full re-sheathability and repositionability—even after a portion of the stent has been deployed, providing doctors with greater control during interventions.

Clinical Efficacy

The initial clinical trials for the ROADSAVER Stent System reveal promising results, indicating its safety and efficacy for symptomatic patients presenting with high-risk lesions. The low complication rates observed position this stent as a contender in the market, offering a reliable option for the treatment of carotid artery stenosis.

Chris Pearson, Executive Vice President for US Commercial Operations at TIS, emphasized the company's ongoing commitment to improving patient outcomes. He stated, "ROADSAVER Stent System exemplifies our relentless pursuit of innovations that enhance procedural predictability and efficiency while providing unparalleled confidence within the healthcare industry."

Market Availability

Currently, the ROADSAVER Carotid Stent System is on track for limited market release during the summer of 2025, aiming for a full market launch in the fall of the same year. TIS is optimistic about the transformative impact this device will have ahead of its mainstream adoption.

About Terumo Interventional Systems

Terumo Interventional Systems (TIS) has established itself as a pioneer in minimally invasive therapeutic interventions. With a commitment to research and development, the company continually strives to innovate in areas such as Transradial Access and Peripheral Artery Disease treatments.

Terumo itself has a rich history, beginning as a thermometer manufacturer over a century ago to evolving into a leading figure in medical technology. Today, Terumo operates in over 160 countries, employing over 30,000 associates dedicated to innovating healthcare solutions.

As the field of interventional medicine continues to advance, solutions like the ROADSAVER Stent System represent invaluable progress in improving vascular health while ensuring patient safety and comfort. Terumo’s dedication to quality and innovation positions it as a frontrunner in delivering effective interventions that meet the needs of patients and healthcare providers alike.