355 nm Cold Laser Atherectomy System: FastErazer CLA-355
FastErazer CLA-355 is a 355 nm wavelength cold laser atherectomy system designed for lesion preparation in lower-limb arterial diseases. Powered by a frequency-tripled Nd:YAG laser, the system works with a portfolio of compatible catheters for the pre-treatment of revascularization of stenotic (including ISR) and occlusive lesions secondary to lower extremity atherosclerotic disease, the reference vessel diameter shall be ≥2 mm.
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Case description: A 63-year-old woman with totally occluded right SFA ISR was effectively treated with CLA-355 and adjunctive DCB angioplasty.
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In-Stent Restenosis (ISR)
FastErazer CLA-355 is specifically designed to modify restenotic tissue without a rotating burr or cutting blade. Its 355 nm cold laser technology enables controlled photoablation of neointimal tissue while minimizing mechanical interaction with the implanted stent structure.
Key Advantages
✓ Indicated for in-stent restenosis (ISR).*
✓ Tissue-selective photoablation of restenotic neointimal tissue. ✓ No rotating element to mechanically engage stent struts, helps preserve the integrity of the implanted stent scaffold. ✓ Provides effective lesion preparation before balloon or drug-coated balloon (DCB) angioplasty. *Indication subject to regulatory approval in the applicable market.
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Chronic Total Occlusion (CTO)
Progressive Recanalization of Chronic Total Occlusions
FastErazer CLA-355 supports controlled photoablation of chronic total occlusions by creating an initial luminal channel through resistant plaque. This facilitates device crossing, improves lesion compliance, and prepares the vessel for following endovascular therapy.
Key Advantages
✓ Facilitates treatment of balloon-uncrossable and balloon-undilatable lesions.
✓ Creates an initial luminal channel to improve device crossability. ✓ Supports controlled, progressive advancement through debulked occlusive tissue. ✓ Provides immediate luminal gain before adjunctive balloon or DCB angioplasty. ✓ Generates micro ablation particles, with a low risk of distal embolization. |
Scroll horizontally to view the complete case · Click image to enlarge
Case description: A 67-year-old man with a 220 mm right SFA CTO underwent successful CLA-355 followed by PTA and DCB, achieving substantial luminal gain.
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Scroll horizontally to view the complete case · Click image to enlarge
Case description: A 56-year-old man with severe anterior tibial artery stenosis was successfully treated with CLA-355 and adjunctive balloon therapy, resulting in marked lumen restoration.
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Below-the-Knee Lesions
True Luminal Gain for Complex Distal Revascularization
Below-the-knee disease is characterized by small vessels, long diffuse lesions, chronic total occlusions, and heavy plaque burden, making effective lesion preparation and durable revascularization particularly challenging. FastErazer CLA-355 combines a low-profile catheter to create true lumen gain, improving device deliverability and optimizing vessel preparation for adjunctive therapy to support limb-preservation strategies in patients with chronic limb-threatening ischemia (CLTI).
Key Advantages
✓ Low-profile 1.2 mm and 2.0 mm catheters with working lengths up to 150 cm provide excellent access to small distal arteries.
✓ Creates true luminal gain through plaque debulking rather than simply displacing plaque with balloon angioplasty. ✓ Optimizes vessel preparation before balloon or drug-coated balloon (DCB) angioplasty, supporting a "leave nothing behind" treatment strategy. ✓ Generates microscopic photoablation particles, supporting a low risk of clinically significant distal embolization. |
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First-in-Human Study
Preliminary Human Safety and FeasibilityThe world's first human application of the CLA-355 system: a prospective, single-center study in nine patients with peripheral artery disease.
Published in Lasers in Medical Science, 2025 |
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Randomized Controlled Trial
Cold Laser Versus Excimer Laser Atherectomy A prospective, multicenter, randomized noninferiority trial comparing 355 nm cold laser atherectomy with 308 nm excimer laser atherectomy in symptomatic lower-extremity peripheral artery disease.
Published in JACC: Cardiovascular Interventions, 2026
Explore the evidence → |
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| LS300-25 | LS300-20 | LS300-12 | |
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| Target Vessel | Femoropopliteal Arteries |
Femoropopliteal & BTK Arteries |
BTK Arteries |
| Guidewire | 0.018 in | 0.018 in | 0.014 in |
| Catheter Length | 120 cm | 150 cm | 150 cm |
| Catheter Ø | 2.5 mm | 2.0 mm | 1.2 mm |
| Sheath Size | 8F / 7F | 6F | 5F |
| Target Vessel Ø | ≥3.5 mm | ≥3.0 mm | ≥1.8 mm |
FastErazer CLA-355 is a 355 nm wavelength cold laser atherectomy system designed for lesion preparation in lower-limb arterial diseases. Powered by a frequency-tripled Nd:YAG laser, the system works with a portfolio of compatible catheters for the pre-treatment of revascularization of stenotic (including ISR) and occlusive lesions secondary to lower extremity atherosclerotic disease, the reference vessel diameter shall be ≥2 mm.
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