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SELUTION SLR PTCA Drug Eluting Balloon

SELUTION SLR PTCA Drug Eluting Balloon

SELUTION SLR PTCA Drug Eluting Balloon

Product catalog summary
Introduction
The SELUTION SLR™ Drug-Eluting Balloon (DEB) is a medical device designed for the treatment of coronary artery disease. It is notable for being the first DEB to receive Breakthrough Device designation by the US FDA. Manufactured by M.A. Med Alliance SA, a Cordis company, it features advanced drug delivery technology.

Specifications
  • Sirolimus Drug Dose: 1.0 μg/mm2
  • Drug Carrier: Cell Adherent Technology (CAT)™ with an amphipathic lipid carrier
  • Catheter Design: Rapid Exchange (RX)
  • Catheter Usable Length: 140 cm
  • Guidewire Compatibility: 0.014”
  • Tip Entry Profile: 0.016"
  • Minimum Guide Catheter Compatibility: 5 Fr for 1.50 – 3.75 mm balloon diameter, 6 Fr for 4.00 – 5.00 mm balloon diameter
  • Nominal Balloon Pressure (NP): 6 bar
  • Rated Burst Pressure (RBP): 12 bar
  • Balloon Diameters: 1.50 mm – 5.00 mm
  • Balloon Lengths: 10, 15, 20, 25, 30, 35, 40 mm

Technology and Features
The SELUTION SLR™ DEB utilizes MicroReservoirs to ensure consistent and predictable drug release, comparable to the latest Drug-Eluting Stent Technology. These MicroReservoirs consist of 4 μm Sirolimus particles mixed with a biodegradable polymer (PLGA). The Cell Adherent Technology (CAT)™ enhances drug uptake and retention in tissue, minimizing drug loss during procedures.

Ordering Information
The device is available in various sizes, with balloon diameters ranging from 1.50 mm to 5.00 mm and lengths from 10 mm to 40 mm, providing a broad size matrix to extend treatment options for coronary artery disease.

Clinical Insights
Early studies with the SELUTION SLR™ DEB show promising results in terms of angiographic late lumen loss (LLL) and diameter of stenosis, indicating its potential effectiveness in treating de novo or restenotic coronary lesions.
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Catalog excerpts

SELUTION SLR PTCA Drug Eluting Balloon-1

Case examples from First-in-Human Coronary Study Pre-intervention Technical Specification AN EARLY STUDY WITH SELUTION SLR DRUG-ELUTING BALLOON shows promising angiographic late lumen loss (LLL) and diameter of stenosis (%).3 ™ Sirolimus Drug Dose Nominal Balloon Pressure (NP) Drug Carrier Cell Adherent Technology (CAT)™ Amphipathic Lipid Carrier Rated Burst Pressure (RBP) Catheter Design Balloon Diameters Catheter Usable Length Balloon Lengths Guidewire Compatibility Minimum Guide Catheter Compatibility (Fr) 1.50 – 3.75 mm balloon diameter: ≥ 5 Fr 4.00 – 5.00 mm balloon diameter: ≥ 6 Fr Ordering Information SELUTION SLR™ Sirolimus Drug-Eluting Balloon Balloon Diameter (mm) In-Stent Restenosis 1. SELUTION SLR DEB was the first Drug Eluting Balloon (DEB) to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA). 2. MedAlliance 2024 Data on File 3. Costa RA, Mandal SC, Hazra PK, Chopda M, Chandra P, Damiani LP, Abizaid A, Hiremath S. Sirolimus-coated balloon with a microsphere-based technology for the treatment of de novo or restenotic coronary lesions. Cardiovasc Revasc Med. 2022 Sep 5:S1553-8389(22)00766-7. doi: 10.1016/j.carrev.2022.08.037. Epub ahead of print. PMID: 36192319. For Healthcare Professionals Only. Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, suggested procedure, warnings and precautions. As part of its continuous product development policy, Cordis reserves the right to change product specifications without prior notification. Please contact your Cordis representative for additional product availability information. SELUTION SLR Drug-Eluting Balloon, CE 0344, is manufactured by M.A. Med Alliance SA and its affiliates. SELUTION SLR is a trademark of M.A. Med Alliance SA. M.A. Med Alliance SA is a Cordis company. CORDIS and Cordis LOGO are trademarks of Cordis and may be registered in the US and/or in other countries. All other marks are the property of their respective owners. © 2024 Cordis. All Rights Reserved. 100640237 05/2024

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SELUTION SLR PTCA Drug Eluting Balloon-2

SELUTION SLR™ DRUG-ELUTING BALLOON A CLASS OF ITS OWN! CELL ADHERENT TECHNOLOGY (CAT)™ CELL ADHERENT TECHNOLOGY (CAT)™ facilitates drug uptake and retention, in the tissue, with a minimal drug loss during the procedure while providing excellent deliverability Don’t compromise on your treatment standard… SELUTION SLR DEB is the latest generation of Drug-Eluting Balloon technology. • Mix of phospholipids containing and protecting MicroReservoirs • 1 μg/mm2 Sirolimus drug dose MICRORESERVOIRS MicroReservoirs achieve a consistent and predictable drug release, at a therapeutic level, equivalent to...

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