Vivolight Medical Highlights Positive 355-nm Cold Laser Atherectomy Trial Findings as TCT 2026 Concludes

San Diego, California — November 3, 2026 — As Transcatheter Cardiovascular Therapeutics (TCT) 2026 draws to a close, Vivolight Medical is highlighting new randomized clinical trial findings showing that investigational 355-nm cold laser atherectomy (CLA) met its prespecified non-inferiority endpoint compared with conventional excimer laser coronary atherectomy in complex coronary lesions.

The findings were presented by Dr. Chenguang Li of Zhongshan Hospital, Fudan University, on November 1 during TCT 2026, providing new clinical evidence supporting continued investigation of 355-nm cold laser technology for challenging coronary interventions.

Randomized Trial: 355-nm Cold Laser Atherectomy Meets Non-Inferiority Endpoint

On November 1, Dr. Li presented Scientific Abstract TCT 1531, "355-nm Cold Laser Atherectomy versus Excimer Laser for Complex Coronary Lesions: A Prospective, Multicenter, Randomized Non-inferiority Trial."

The prospective, multicenter, randomized study was conducted across six clinical centers in China between December 2024 and June 2025. A total of 228 patients were randomized to 355-nm CLA or conventional 308-nm excimer laser coronary atherectomy (ELCA).

The reported primary endpoint analysis included 226 patients, with 115 in the CLA group and 111 in the ELCA group.

The study investigated lesion preparation in complex coronary conditions, including in-stent restenosis (ISR), chronic total occlusions (CTO), calcified lesions, balloon-uncrossable or undilatable lesions, and underexpanded stents.

The primary endpoint was procedural success, defined by residual stenosis of 30% or less, TIMI grade 3 blood flow, and the absence of laser-related complications.

The trial met its prespecified primary endpoint for non-inferiority.

Procedural success was achieved in 94.8% of patients in the CLA group, compared with 88.3% in the ELCA group.

The center-adjusted difference in procedural success was 6.9 percentage points, with a 95% confidence interval of −0.9 to 14.9 percentage points. The lower confidence limit exceeded the prespecified non-inferiority margin of −10 percentage points.

An additional analysis showed that a higher proportion of patients in the CLA group achieved residual stenosis of 30% or less following PCI (96.5% versus 89.2%; P=0.032).

These findings support the potential of 355-nm cold laser atherectomy as an alternative approach to lesion preparation in complex coronary intervention, while further clinical investigation remains important.

Six-Month Outcomes Provide Additional Clinical Insights

The study also reported clinical outcomes through six months of follow-up.

Major adverse cardiac events (MACE), defined as cardiac death, target lesion myocardial infarction, or target lesion revascularization, occurred in 7.0% of patients in the CLA group and 4.5% in the ELCA group, with no statistically significant difference observed between groups (P=0.429).

Target lesion revascularization (TLR) occurred in 5.2% and 3.6% of patients, respectively, also without a statistically significant difference (P=0.749).

No device-related serious adverse events or device defects were reported in either group.

Although the trial demonstrated non-inferiority for procedural success, longer-term follow-up and additional clinical studies remain important to further characterize safety, efficacy, and the technology's potential role in coronary intervention.

Advancing 355-nm Cold Laser Technology: From Coronary Research to Peripheral Vascular Applications

The newly presented coronary trial findings reflect Vivolight Medical's broader efforts to advance 355-nm cold laser technology for complex vascular interventions.

The technology employs a solid-state laser platform that delivers nanosecond pulses for plaque modification. Unlike conventional gas-based excimer laser systems, its design does not require excimer laser gas replenishment. The compact system architecture and shorter warm-up time also offer potential practical advantages in clinical operation and maintenance.

Beyond coronary research, Vivolight Medical has achieved a regulatory milestone in peripheral arterial intervention.

In June 2026, FastErazer CLA-355 Cold Laser Atherectomy System, developed within the Vivolight group, received approval from China's National Medical Products Administration (NMPA), under registration number 20263011296.

Used with specified disposable laser fiber catheters, FastErazer is approved in China for lesion preparation in the treatment of lower-limb atherosclerotic arterial stenosis, including in-stent restenosis, and occlusive arterial lesions.

This approval represents an important step in the clinical application of 355-nm cold laser technology for peripheral vascular intervention.

While its coronary application remains investigational, the progress in peripheral arterial treatment highlights Vivolight's continued efforts to translate laser-based innovation into clinical practice across different vascular applications.

TCT 2026: Connecting Clinical Research with Imaging Innovation

Alongside the presentation of 355-nm cold laser research, Vivolight Medical's participation at TCT 2026 also highlighted advances in intravascular optical coherence tomography (OCT) and its clinical relevance in complex coronary intervention.

On October 31, Dr. Lam Lap Tin's team from Hong Kong shared a clinical case entitled "A Case of Utilizing OCT in Bifurcation Stenting – Procedural Planning and Bail-out" (TCT 1729) during the CHIP: Imaging-Guided Bifurcation Techniques session.

The case explored the role of OCT in procedural planning and bail-out decision-making during complex coronary bifurcation stenting, highlighting the value of detailed intravascular imaging in guiding interventional strategies.

During the exhibition, Vivolight showcased its FDA-cleared Cornaris P80-E Intravascular Imaging System at Booth 3321, engaging with physicians and industry professionals on the clinical applications of high-resolution coronary imaging.

Together, the scientific presentations and exhibition activities highlighted Vivolight's continued efforts to connect advanced diagnostic imaging, emerging therapeutic technologies, and clinical research.

Moving Forward Through Innovation and Collaboration

Vivolight Medical's participation at TCT 2026 brought together developments in intravascular OCT imaging, randomized clinical research, and international scientific exchange.

The newly presented 355-nm cold laser findings provide further evidence supporting continued clinical investigation, while the company's progress in peripheral laser atherectomy and intravascular imaging reflects its commitment to addressing evolving needs in cardiovascular intervention.

As the conference concludes, Vivolight extends its appreciation to the physicians, researchers, and industry professionals who contributed to discussions throughout the event.

Looking ahead, Vivolight Medical will continue to advance laser-based diagnostic and therapeutic technologies, strengthen clinical research, and foster international collaboration in developing minimally invasive cardiovascular solutions.