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RESISTANT XL

NITINOL SELF-EXPANDABLE AORTIC STENT

Resistant XL is a self-expandable aortic stenting system consisting of two main components:
Self-expandable nitinol stent with tantalum markers.

Pull-back coaxial support system on which stent is mounted. Support system is introduced into the body directly or, if necessary, through an introducer: 12 F (for diameters of 14-22 mm), 14 F (for diameters of 24-32 mm) or 16 F (for diameters of 36-40 mm). Release delivery system is 100 cm long and can be used with 0.035’’ (0.89 mm) guide. Atraumatic tip. Stent self-expansion mechanism is activated withdrawing the external catheter of the support system. The aortic stent reaches its nominal diameter and covers the section of damaged vessel. Aortic stents can be adapted gradually to the vascular wall with the help of an appropriate balloon catheter if necessary.

This stent has a special rhomboid mesh hybrid structure: with closed cells at the proximal and distal end to create a higher radial force gradient for greater aortic wall anchorage. Whereas, the central part of the stent mesh is open celled, thus more flexible and adaptable to twisting structures

 

 

 

 

 

 

Each end of the stent has 5 radio opaque tantalum markers for greater radio opacity during positioning. Closed cell length at the proximal and distal end depends on the total length of the stent with a distance between crowns of 0.5 mm with a minimum of 1.5 mm in 70mm long stents up to a maximum of 2.5 mm in 130,150, 180 and 200 mm long stents.

 

 

 

 

 

 

INDICATIONS

Resistant XL stents are recommended to treat dissections, stenosis and other specific lesions of the descending thoracic aorta and abdominal aorta and to treat vena cava syndrome, whose anatomic dimensions correspond to those stent sizes available. Therefore, application is limited to adult patients only. Resistant XL stents are mainly recommended for:

  • Dissections (aortic type B and within area of renal or visceral arteries)
  • Stenosis of the aorta
  • Atherosclerotic aortic stenosis
  • Poor angioplasty outcome § Anastomotic elastic stenosis (bypass)
  • 1a and 1b type endoleak (stabilization of stent grafts displaying signs of folding deformation or stent migration due to insufficient fastening)
  • Obstructions or superior or inferior vena cava congestion due to malignant or benign causes (cancer treatment) Type of indication:
  • In the abdominal aorta, in the rectilinear area of the descending thoracic aorta as well as the distal aortic arch of the left subclavian artery outlet
  • In the vena cava with superior or inferior congestion

STORAGE AND STERILSATION

Resistant XL stents are single use products sterilised with ethylene oxide supplied in a sterile pack. They remain sterile until opened or damaged. Product is apyrogenic. Stenting system must be stored in a dry, cool and dark place (10-25°C). Avoid exposure to direct sunlight. Heat could have a significant negative effect on product functionality. Do not expose stent to ionising radiation or ultraviolet light. Supplied in individual packs.

SIZES AND CODES

SUPPOERT SYSTEM

Support system consists of an internal catheter (5) and external catheter (6). Internal catheter lumen also acts as a guide lumen. Stent (4) is fixed between the internal and external catheters, on the distal end of the support system. Two radio opaque rings (3) mark the proximal and distal end of the stent to facilitate stent positioning within the body. The distal end of the internal catheter has a soft atraumatic tip (2).
The proximal end of the internal catheter (5) is connected to a stainless steel tube (9), the so-called pusher. This tube passes through a haemostatic valve within the anterior distal grip (7) and emerges in the posterior proximal grip (10) in a luer lock connector (11), where the guide exits. The external catheter is connected to the anterior grip. The haemostatic valve is supplied closed. It must remain completely closed before system operation and introduction to prevent the stent from releasing prematurely. Haemostatic valve is opened turning the blue stop ring (8) on the anterior grip in the direction of the arrow and closed turning the ring in the opposite direction to the arrow. System is washed through the lateral luer lock connectors (1) and proximal luer lock connectors (11). Open the haemostatic valve and keep the posterior (proximal) grip (10) in position with the steel tube (9) to pull the stent out. At the same time the anterior (distal) grip (7) and external catheter (6) is pulled out through the steel tube (9) in a proximal direction.

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