Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 28mm Rapid
Esprit™ - 1203350-28
Device Description
A bioabsorbable polymer tubular mesh structure with a drug coating intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain luminal patency in patients with symptomatic atherosclerotic disease [e.g., critical limb ischemia (CLI), severe leg claudication]; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation may be included with the device.
Environmental Conditions
- Keep dry and away from sunlight. Store at or below 25°C (77°F); temporary excursions up to 30°C (86°F) are permissible if the temperature monitor confirms suitability. Check monitor before use.
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NXW
Device Name: Scaffold, Infrapopliteal, Absorbable
Device Class: 3
Physical State: Absorbable stent or scaffold and delivery catheter
Definition: The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
Submission Type ID: 2
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Absorbable stent or scaffold placed via a delivery catheter into the native infrapopliteal arteries
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: native infrapopliteal arteries
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 08717648357077
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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