EluPro Antibiotic-Eluting Envelope

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Content  

INTENDED USE/INDICATIONS FOR USE

EluPro is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with EluPro include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators and other neurostimulator devices. 

EluPro contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.

CONTRAINDICATIONS

EluPro is NOT indicated for use in the following situations:

• Patients with a known sensitivity to porcine material.

• Allergy or history of allergy to tetracyclines, rifampin, or resorbable sutures.

• In patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition.

• Contaminated or infected sites.

WARNINGS AND PRECAUTIONS

• Only physicians qualified in the placement of CIEDs or implantable neurostimulators, such as vagus nerve stimulators, spinal cord neurostimulators, deep brain stimulators, sacral nerve stimulators and other neurostimulator devices, should use this device.

• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization will compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.

• Discard all open or unused product.

• Product is sterile if the package is dry, unopened, and undamaged. Do not use if the package seal is broken. Discard if mishandling has caused possible damage or contamination.

• Do not use if required storage conditions have not been maintained.

• The product must be used prior to the ‘Use-by Date’.

• Always handle product using aseptic technique.Ensure that the product is hydrated according to instructions, or it may tear or may not retain sutures. 

• Do not use with fibrin glue or glue containing glutaraldehyde or other cross-linking agents.

• The use of EluPro has not been studied in the pediatric population. As with other antibacterial therapies, possible teratogenic effects in pregnant women should be carefully considered relative to the therapeutic benefit.

• Caution should be exercised in patients with compromised hepatic function, renal impairment, or those concurrently taking medications known to affect renal function. Rifampin and minocycline can potentially exacerbate hepatic and renal stress in such individuals.

POTENTIAL ADVERSE EVENTS

The following device-related complications are possible:

• Allergic reaction or hypersensitivity to ECM, antibiotic(s) or suture

• Bleeding

• Calcification

• Fibrosis

• Fever

• Hematoma 

• Infection

• Inflammation

• Seroma

• Undesired remodeling

• Hepatic or renal toxicity

Any potential adverse incident involving EluPro should be reported immediately. Please report any device-related adverse events to Elutia at +1 470-514-4080.