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angiolite

Product catalog summary

Introduction
The document presents a preclinical study of the Angiolite Sirolimus eluting coronary stent system, comparing its performance to the Xience stent and bare-metal stents (BMS). The study focuses on coating durability, optimal kinetics, safety, and efficacy.

Specifications
The Angiolite stent features a proprietary hydrophilic coating with long-lasting durability, a trilayer balloon for fast deflation, and advanced crimping technology. It is compatible with a 0.014” guidewire and a 5F guiding catheter. The stent material is CoCr L605 with a strut thickness of 75-85 µm, and it uses a fluorinated acrylate polymer to deliver 1.4 µg/mm² of Sirolimus.

Procedures
The study involved a 28-day angiographic and histomorphometric follow-up using an over-expansion swine model. A total of 33 stents were randomized across the three major coronary arteries.

Results

Safety: Angiolite showed improved endothelialization rates and less inflammation compared to Xience, with a statistically significant difference in inflammatory scores (p=0.0098).
Efficacy: The 28-day histological analysis indicated that restenosis rates were equivalent to Xience. The ANCHOR study with 103 patients confirmed high safety and efficacy, with a target lesion failure rate of 1% and binary restenosis of 0% at 6 months.

Design and Features
The stent design includes alternate spiral links and an open cell design for enhanced radial force. The balloon material is a combination of Nylon and Pebax, providing a semi-compliant structure with a mean deflation time of 3 seconds.

Conclusion
The Angiolite stent system demonstrates superior safety and efficacy compared to second-generation DES and BMS, supported by preclinical and clinical trial data. Its advanced design and coating technology contribute to its performance in reducing restenosis and inflammation.

Catalog excerpts

angiolite Sirolimus eluting coronary stent sytem Coating durability & optimal kinetics CA

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mechanical integrity Fast deflation Trilayer balloon Advanced crimping technology 1 Proprietary hydrophilic coating with long lasting durability PEBAX: anti-dislodgement Soft layer for cushion effect NYLON: anti-puncture Reinforced inner layers Open cell design Outstanding radial force Alternate spiral links * Statistically significant difference 28-day histological analysis restenosis is equivalent to Xience Assess safety & efficacy of new generation DES (angiolite) vs 2nd gen DES (Xience) and BMS Over-expansion swine model 33 stents randomized over the 3 major coronary arteries 28-day angiographic...

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homogeneous drug delivery BMS - CoCr Acrylate Proprietary nanodrop coating technology Artery Coating integrity clinical trial The ANCHOR study results confirm the safety and efficacy of the Angiolite for the treatment of patients with de novo lesions. OCT 3-month follow-up Covered struts rate 86,3% High Efficacy High Safety At 6-month proven and mainly supported by binary restenosis 0% in-stent LLL 0,07mm. Supported by a very low target lesion failure rate 1%, caused by 1% of target lesion revascularization at 6-month. ANCHOR Study angiolite - Sirolimus eluting coronary stent sytem

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> Rapid Exchange catheter (RX) > Compatible with 0.014” guidewire > Compatible with 5F guiding catheter > Tip profile: 0.016” > Crossing profile from 0.043” to 0.051” > 2 radiopaque markers (Pt-Ir) > Balloon material: Nylon and Pebax > Semi-compliant balloon > Mean deflation time: 3s > NP: 9-12 atm | RBP = 16 atm | ABP = 22 atm > Stent material: CoCr L605 > Strut thickness 75 pm - 85 pm > Recoil < 5% > Shortening at expansion < 3% > Drug: 1.4 pg/mm2 Sirolimus > Polymer: Fluorinated acrylate Product with CE mark, certified by Notified Body 0318 MVManufactured by:LVD Biotech, S.L. www.ivascular.global [email protected]...

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angiolite

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Catalog excerpts

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