Manufacturer > InnoTherapy America > Devices > InnoSeal Hemostatic Pad

InnoSeal Hemostatic Pad

Device-Type

Assisted Compression Devices

Targated Speciality

Coronary

Manufacturer

InnoTherapy America

InnoSEAL Hemostatic Pad is a hydrophilic lyophilized sponge pad for local management of bleeding wound made of proprietary formulation of Chitosan and catechol conjugated Chitosan which are biocompatible. InnoSEAL Hemostatic Pad applied topically as an adjunct to manual compression. InnoSEAL Hemostatic Pad is a single use device individually packaged by PET mold and Aluminum lid and sterilized with gamma irradiation. A box contains 10 single use pads.

Features and Benefits


  • Accelerates clot formation and maintains stable clot.
  • Works independently from clotting cascade.
  • Massively porous sponge pad absorbs bleeding.
  • Less compression time when used as an adjunct to manual compression.
  • Odorless. Easy to use, fold, or cut.
  • Non-woven soft pad conforms to all wound surfaces.
  • Easily removable.


Once applied to the affected area, InnoSEAL Hemostatic Pad reacts on contact with blood, sealing the wound.


1. Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact.

  1. Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact.

2. Immediate formation of InnoSEAL-induced blood plugs via electrostatic interactions.

  1. Immediate formation of InnoSEAL-induced blood plugs via electrostatic interactions.

The catechol groups in InnoSEAL reveal stable tissue adhesion.

The catechol groups in InnoSEAL reveal stable tissue adhesion.


Safety informations

InnoSEAL Hemostatic Pad is intended for the local management of bleeding wounds and for the promotion of rapid control of bleeding. InnoSEAL Hemostatic Pad is intended for use under the care of a healthcare professional. The dressing is indicated for following wounds; lacerations, abrasions, and the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes.


PRECAUTION

  • Not for intravascular use.
  • Do not use if the seal is broken or damaged.
  • The InnoSEAL Hemostatic Pad is supplied as sterile, single-use. Do not re-use. Do not attempt to re-sterilize.
  • The InnoSEAL Hemostatic Pad is non-absorbable pad.
  • Do not touch InnoSEAL Hemostatic Pad with wet gloves or expose InnoSEAL Hemostatic Pad to liquid. Absorption of the liquid will cause the destruction of InnoSEAL Hemostatic Pad.


INSTRUCTION FOR USE

  • Apply pressure proximal to wound site.
  • Place InnoSEAL Hemostatic Pad to the cleaned wound and apply a clean sterile gauze over the InnoSEAL Hemostatic Pad. Either side of InnoSEAL Hemostatic Pad can be used. When using more than one InnoSEAL Hemostatic Pad, each InnoSEAL Hemostatic Pad should be overlapped.
  • Gradually release proximal pressure to permit a small amount of blood to contact InnoSEAL Hemostatic Pad.
  • Apply continuous pressure over the InnoSEAL Hemostatic Pad while maintaining proximal hold.
  • Slowly release proximal hold while maintaining contact over the InnoSEAL Hemostatic Pad until hemostatsis is achieved.
  • Once hemostasis has been confirmed, apply choice of adhesive bandage directly on the skin over the InnoSEAL Hemostatic Pad access site.

Potential adverse events

Complications may include, but are not limited to; Bleeding, Hematoma, Pseudoaneurysm, Rash, Swelling.

Device Documents

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