CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE / INDICATIONS FOR USE

The SELUTION SLR^TM 014 PTCA Drug-Eluting Balloon (DEB) is intended to be used after appropriate vessel preparation in patients undergoing percutaneous coronary intervention (PCI) in coronary arteries 2.25 mm to 4.50 mm in diameter and lesions ≤ 26 mm in length for the purpose of improving myocardial perfusion when treating in-stent restenosis (ISR)

CONTRAINDICATIONS

The SELUTION SLR 014 PTCA DEB is contraindicated for use in:

• Patients with known allergies or hypersensitivities to sirolimus (or analogs).
• Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy.
• The supra-aortic and cerebrovascular arteries
• Patients with unprotected native left main coronary artery disease
• Patients with coronary artery spasms in the absence of a significant stenosis
• Pregnant or breast-feeding women or women who are intending to become pregnant, or men intending to father children.
   

WARNINGS

When using this type of device, the following warnings should be observed:

• Contents are supplied STERILE using an E-beam irradiation sterilization process. DO NOT USE if the sterile barrier is damaged or opened prior to intended use.
• DO NOT USE SELUTION SLR PTCA DEB after the labeled “Use By” date.
• Use the recommended balloon inflation medium (50:50 mixture of contrast medium and sterile saline solution). Never use air or any gaseous medium to inflate the balloon.
• Do not advance or withdraw the catheter unless the drug-eluting balloon is fully deflated under vacuum.
• If unusual resistance is felt during manipulation, determine the cause of the resistance before proceeding.  If the source of resistance cannot be determined, it is recommended to extract the entire system (as a unit) with the guide catheter.
• DO NOT EXCEED the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure-monitoring device is recommended.
• Once inflation has begun, do not move or reposition the SELUTION SLR PTCA DEB.
• Each SELUTION SLR PTCA DEB is intended for a single inflation only.
• To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.
• As for all PCI procedures, use in patients who are not acceptable candidates for open heart surgery requires careful consideration, including possible hemodynamic support during the procedure, as treatment of this patient population carries special risk.

PRECAUTIONS 

General Precautions

• For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
• Based on the results of the SELUTION4ISR study, the use of the SELUTION SLR PTCA DEB may be most appropriate where additional stent implantation is considered undesirable or not feasible.
• The SELUTION SLR PTCA DEB should only be used by physicians appropriately trained in PTCA procedures.
• Do not expose SELUTION SLR PTCA DEB to organic solvents such as alcohol.
• As for all PCI procedures, the need for on-site surgical backup should be considered.
• Use caution in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated.
• Never advance the drug-coated balloon catheter without the guidewire extending from the tip. Do not use the SELUTION SLR PTCA DEB if the lesion is unable to be crossed with a guidewire.
• Significant stenosis (> 50 %) proximal to the treatment site should be pretreated.
• The SELUTION SLR PTCA DEB is indicated for lesions up to 26 mm.  The safety and effectiveness of treating lesions longer than 26 mm has not been established.
• The treatment site should be adequately prepared (intravascular imaging guidance recommended) to achieve the maximum lumen diameter prior to treatment with the SELUTION SLR PTCA DEB.
• Excessive handling or contact with liquids to the drug coating should be avoided as the coating may be susceptible to premature drug release or catheter damage. Do not touch the drug-eluting balloon.
• The balloon protective sheath and disposable wire stylet must stay in place during preparation of the SELUTION SLR PTCA DEB and not be removed until just prior to flushing with saline and placing the device over the guidewire.
• Remove the balloon protective sheath distally and discard. If difficulty is encountered while removing the balloon protective sheath, a new SELUTION SLR PTCA DEB must be utilized.
• During insertion, do not over-tighten the hemostasis valve around the SELUTION SLR PTCA DEB shaft as lumen constriction may occur, affecting inflation/deflation of the balloon.
• Use direct fluoroscopic visualization when advancing the balloon catheter over the guidewire, positioning it in the lesion to be treated, and during balloon inflation.
• Do not use the SELUTION SLR PTCA DEB if the shaft has been bent or kinked.
• The safety and effectiveness of using more than one SELUTION SLR PTCA DEB to treat a single lesion or multiple lesions/vessels per procedure has not been established.
• Do not use a second drug-eluting balloon at the same treatment site.
• Whenever possible, the SELUTION SLR PTCA DEB should be the final treatment of the vessel.
• After use, the SELUTION SLR PTCA DEB is a biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable hospital, administrative, and government regulations. 
• The optimal duration of dual anti-platelet therapy (DAPT) post PCI for ISR is currently unknown. The 2023 SCAI Expert Consensus has suggested that DAPT should be used for a minimum of one month post ISR PCI. While the SELUTION4ISR Study required that enrolled subjects receive a minimum of 1-month of DAPT, more than 60% of patients remained on DAPT for at least 1 year. In conjunction with this information, operators should use clinical judgment in deciding on the duration of DAPT following use of the SELUTION SLR PTCA DEB.

ADVERSE EVENTS

Potential adverse events, which may be associated with a PTCA procedure, include, but are not limited to:

Potential adverse events related to the oral administration of the active pharmaceutical ingredient (sirolimus) include, but are not limited to:

The potential adverse events listed above are related to systemic orally-administered sirolimus at higher doses than what would be delivered by the application of one SELUTION SLR PTCA DEB locally to the vessel wall.

SELUTION SLR is a trademark of M.A. Med Alliance SA.  MedAlliance, LLC is a Cordis company.