Danis Seal

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Danis Seal

References

Description

Features

Implantation

Available sizes

Publications

PERSONAL REFERENCES

Dept. of Surgery, Oberhavel Kliniken GmbH, Germany

“We have many years of experience with the Danis Seal stent. It is a very useful tool for minimal invasive treatment of anastomotic leaks, fistulae and perforations in the esophagus and gastroesophageal junction. "
Advantages of the stent include easy application, large diameter, and near total cover. The loops at both ends of the stent allow intraluminal advancement or withdrawal and repositioning. Therefore, healing of the leaks can be assessed without removal of the stents. Most leaks heal within 3 weeks thus avoiding another operation.

BASIC DESCRIPTION

The Danis Seal is a fully covered self-expandable nitinol esophageal stent for the treatment of esophageal leaks and ruptures. The large diameter with optimal length and expansion force, durable silicone coating and special anti-migration design make this stent the ideal solution in appropriate situations.

Indication

The Danis Seal is indicated for patients aged 18 and older and is indicated for the treatment of esophageal or gastric leakage from:

  • Anastomotic wound dehiscence (after esophagectomy, gastric bypass),
  • Esophageal ruptures / perforations (spontaneous rupture – Boerhaave’s syndrome; iatrogenic rupture / perforation occurring during esophageal dilations, endoscopic manipulations, traumatic esophageal ruptures due to blunt thoracic trauma).

Features / Benefits

The wide diameter of the Danis Seal helps to optimally adhere to the esophageal wall.
The unique design of braiding of this stent is adapted to esophageal peristalsis and, together with enlarged flares, reduces the risk of migration. The uncovered stent edges allow tissue ingrowth, helping to seal the space between the stent and the tissue.
The stent has a high-strength, acid-resistant retrieval loop at both ends that allows the stent to be safely and ergonomically removed from the esophagus.
The Danis Seal is fully covered with durable silicone, which allows easy extraction and at the same time the cover protects the nitinol wires from contact with stomach acids and potential corrosion.
Platinum-iridium radiopaque markers located at both ends and in the center of the stent allow good visibility and accurate stent placement.
MRI compatibility – “MR Conditional”, compatible with 1.5 Tesla and 3 Tesla static magnetic field.

Patent protected

Implantation

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.

Danis Seal implantation

Available sizes

REF No. Esophageal Stent Danis Seal Delivery system
Stent flares diameter [mm] Stent body diameter [mm] Nominal length [mm] Active length [cm] Outer diameter [F]
019-11-25-135 30 25 135 75 28 / 18

Leaflets

DANIS SEAL

(PDF)

Publications

Jacob Freedman, M.D., Ph.D., Eduard Jonas, M.D., Ph.D., Erik Näslund, M.D., Ph.D.a,Henrik Nilsson, M.D., Ph.D., Richard Marsk, M.D., Ph.D., Dag Stockeld, M.D., Ph.D.

Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, SwedenbClintec, Karolinska Institutet, Department of Surgery, Karolinska University Hospital, Stockholm, SwedenReceived November 17, 2011; accepted March 12, 2012

Yiyang Dai, MD, Sascha S. Chopra, MD,†Markus Steinbach, MD,Sören Kneif, MD and Michael Hünerbein, MD, PhD

Semin Thoracic Surg 23:159-162© 2011 Elsevier Inc.

Brogyuk N. Bunganič B., Zavoral M., et al.

XXI. Gastroforum; Štrbské Pleso; Slovakia January 24, 2016

For more information on publications, visit our Education section.