Device Dossier

SX-ELLA Stent Esophageal Degradable BD Stent (BD Stent) - Oesophageal biodegradable scaffold

Device Dossier for SX-ELLA Stent Esophageal Degradable BD Stent (BD Stent) - Oesophageal biodegradable scaffold (Oesophageal biodegradable scaffold,…

Intended purpose

The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions namely: - stenosis (peptic, anastomotic or caustic) refractory to standard therapy, - achalasia refractory to standard therapy.

Functional description

A self-expanding braided stent made of monofilament polydioxanone fiber (cylinder with flared ends & gold markers).The delivery system 28/18 F consists of the coaxially arranged plastic tubes: sheath, pusher and shaft with olive.The stent is deployed via the delivery system into the esophagus and continues to gradually expand until it reaches full diameter (~48 hours).Integrity and radial force is maintained for up to 8 weeks before biodegradation (after 11-12 weeks).

TGA Public Summary