EndoClot®

Dénomination commerciale

EndoClot®

36972011720213

B-36972011720213

Numéro de référence/catalogue

SIS-30

GS1

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

EndoClot® Submucosal Injection System (EndoClot® SIS) is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other endoscopic device. EndoClot® SIS is to be used in endoscopic resection procedures during endoscopic examinations in the upper and the lower gastrointestinal tract, such as the esophagus, the stomach, the intestine, the colon and the rectum. It is designed to elevate the mucosal layer and the tissue to be excised from the submucosal and the external muscular layer. EndoClot® SIS is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP® ) particles in a plastic bottle and a spiral plunger syringe. AMP® particles are derived from plant starch. The syringe has a 6% Luer lock fitting to ensure secure connection to a standard, commercially available endoscopic injection needle. The EndoClot® SIS solution can be injected by rotating the plunger.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 1–1.1 MU24

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CONTRAINDICATIONS Patients with known sensitivity to starch and starch-derived materials. Do not inject into blood vessels WARNING AND PRECAUTIONS The endoscopist injecting EndoClot® SIS solution must be experienced in the administration technique. Use of EndoClot® SIS in pediatric populations and pregnant or lactating women has not been studied. To use EndoClot® SIS in these populations is at the discretion of the healthcare professional. EndoClot® SIS is a single use medical device. Any EndoClot® SIS solution not injected during the procedure should not be reused for another endoscopic procedure. Do not use if the packaging is damaged. When methylene blue is selected as a dye or Epinephrine is used inconjunction with EndoClot® SIS solution, please follow your association or hospital guidelines when preparing with Saline. For example: Add sterile saline containing no more than 0.08mg/mL of methylene blue to the plastic bottle containing the AMP® particles. Use 15ml of saline for SIS-15 and 30ml of saline for SIS-30 respectively. Shake well until AMP® particles are dissolved before each injection. For Epinephrine, add no more than 0.1mg/mL Epinephrine into sterile saline before the preparation. Note that methylene blue and Epinephrine have been tested and are compatible with EndoClot® SIS solution. No chemical reactions occurred when 1g of AMP® particles were mixed with 30ml of saline containing 2.5mg methylene blue or 3mg Epinephrine for 6 hours.

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