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Magmaris

Product catalog summary

Introduction
The document provides detailed information on the Magmaris Resorbable Magnesium Scaffold (RMS) used in coronary vascular interventions. It highlights the scaffold's mechanical properties, safety data, resorption time, and technical specifications.

Mechanical Properties
The Magmaris scaffold is made from a proprietary magnesium alloy, offering superior mechanical strength compared to polymeric materials like PLLA. It demonstrates strong radial resistance and stable recoil, with a 38% lower recoil after one hour compared to polymeric scaffolds.

Safety Data
Clinical trials (BIOSOLVE-I to IV) show low target lesion failure (TLF) rates over 12 to 36 months, with no significant scaffold thrombosis reported. The magnesium scaffold is absorbed by the body, with approximately 95% resorption at 12 months.

Resorption and Endothelialization
Optical Coherence Tomography (OCT) imaging shows that the scaffold is well apposed to the vessel wall immediately after implantation. By 12 months, magnesium resorption is nearly complete, and endothelialization progresses.

Deliverability
Magmaris is rated better than polymeric scaffolds by over 70% of physicians due to its lower lesion entry and crossing force, better trackability, and pushability.

Technical Specifications
The scaffold features a magnesium alloy with two tantalum markers at each end. It has a strut thickness of 150 μm and is coated with BIOlute, a resorbable Poly-L-Lactide (PLLA) eluting a limus drug. The delivery system includes a rapid exchange catheter with a recommended guide catheter size of 6F.

Ordering Information
The document provides ordering codes for different scaffold diameters and lengths, ensuring easy procurement for medical facilities.

Conclusion
The Magmaris RMS offers a compelling combination of safety, efficacy, and deliverability, making it a preferred choice for treating de novo coronary artery lesions.

Catalog excerpts

Compelling safety data Fast Magnesium resorption time Better deliverability Vascular Intervention // Coronary Resorbable Magnesium Scaffold (RMS) Technical data / ordering info

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Why Magnesium? Magnesium alloy: favourable mechanical properties of a robust Magnesium backbone Robust Magnesium backbone The mechanical strength of Magnesium is superior to polymers like PLLA. Strain (%) Magnesium Stainless Steel Strong radial resistance No significant diameter change under increasing physiological pressure. Scaffold diameter (mm) Polymeric scaffold* Stable recoil M agmaris has a 38% lower recoil after 1 hour.2 Acute recoil Magmaris 3.0/20 Polymeric scaffold* 3.0/18 Recoil after 1 hour Magmaris 3.0/20 4 6 8 Proximal mean force (N) *Absorb, Abbott Rounded edges and smooth surface...

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Compelling safety data Confidence through evidence 12 months Definite/probable scaffold thrombosis Definite/probable scaffold thrombosis Definite/probable scaffold thrombosis Definite/probable scaffold thrombosis *Target Lesion Failure. Composite of cardiac and unknown death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG. **Patient underwent MIDCAB with subsequent DAPT interruption 5 days after the procedure.

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Fast resorption time ~95% of Magnesium resorbed at 12 months9 Immediately after implantation, struts are well apposed to the vessel wall. While the Magnesium resorption process continues, endothelialization progresses. At 12 months after implantation, the Magnesium resorption is almost completed. At 36 months the lumen is well preserved with a homogeneous surface.

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A more deliverable scaffold More than 70% of physicians who have used Magmaris RMS in clinical practice have rated the device to be better than a polymeric scaffold.11* Better lesion crossing Up to 40% lower lesion entry and crossing force.12 Lesion crossing ■ Magmaris ■ Polymeric scaffold* Lesion entry 42% less peak force. Stent/Scaffold strut thickness in perspective Polymeric scaffold* Stainless Steel DES** Polymeric scaffold* Better pushability 73% more force transmitted from hub to tip. Polymeric scaffold* Stainless Steel DES** * Absorb, Abbott ** BioFreedom, Biosensors

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Magmaris Indicated for de novo coronary artery Lesions.* Vascular Intervention Coronary Technical Data Scaffold Scaffold material Proprietary Magnesium alloy Markers Two tantalum markers at each end Active coating BlOlute (resorbable PoLy-L-Lactide (PLLA) eluting a Limus drug) Drug dose 1.4 pg/mm2 Maximum expandable diameter Nominal Diameter +0.6 mm Delivery system Catheter type Recommended guide catheter Crossing profile Guide wire diameter Usable catheter Length Balloon material Coating (distal shaft) Marker bands Proximal shaft diameter Distal shaft diameter Nominal pressure (NP) Rate burst...

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Magmaris

Magmaris

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