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The Flexella Plus is a fully covered self-expandable nitinol esophageal stent. The low migration rate and prevention of tissue ingrowth is complemented by safe and reliable extractability. If the stent is implanted in the distal part of the esophagus and protrudes into the cardia, it may be equipped with an anti-reflux valve that prevents reflux of gastric juices.
The Flexella Plus is intended for patients aged 18 and older and indicated for palliative treatment of malignant dysphagia, for sealing malignant esophagorespiratory or esophagomediastinal fistula. The device can be temporarily implanted in patients with refractory benign esophageal strictures.
The universal low-profile and flexible 16/22 F delivery system allows easy insertion even into tough stenoses. For strictures located in the upper part of the esophagus, it is possible to use a PUSH-type delivery system with proximal stent release for accurate placement of the stent rim.
There are metallic retrieval loops with high strength and resistance to acidic environment at both stent ends. Retrieval loops in combination with centripetally tapering flares allow safe and ergonomic removal of the stent from the esophagus.
The stent has a high radial force for effective dilation of the stricture and resistance to external pressure.
The Flexella Plus is fully covered by durable silicone, which prevents tumor ingrowth into the stent and allows easy extraction. At the same time, the covering protects the nitinol mesh from contact with stomach acids and potential corrosion.
Platinum-iridium markers located at both ends and in the midpoint of the stent ensure visibility of the stent under X-ray.
The stent has atraumatic fully covered flares that reduce esophageal wall irritation and tissue response.
If the Flexella PLUS stent is implanted in the distal part of the esophagus, it can be equipped with an anti-reflux valve.
MRI compatibility - "MR Conditional", compatible with 1.5 Tesla and 3 Tesla static magnetic field.
The stent is delivered sterile and compressed in the delivery system. We recommend using a 0.035” (0.89 mm) / 220 cm ultra-stiff guidewire for the implantation.
