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Hylomate Pouch is an implantable seamless pouch manufactured from pure biosynthesized cellulose which provides long term protection of the surgical pocket tissue from fibrotic tissue build up associated with the foreign body reaction against implantable pulse generators (IPGs).

Implantable Pulse Generators provide electrical stimulation and are integral parts of devices such as pacemakers, implantable cardioverter defibrillators, or neurostimulators. IPGs remain implanted for several years before either being exchanged due to battery depletion, or upgrade to device providing additional functionality.

Excellent biocompatibility

Hylomate Pouch generates an ideal interface with the surrounding tissues, hiding completely the foreign materials of the IPG from recognition by the human body.

Permanent Device Stabilization

Hylomate Pouch intends to provide permanent stabilization of the generator implant pocket around cardiac implantable electronic devices and neurostimulators.

Facilitate revision surgery

Hylomate Pouch may facilitate revision surgery by eliminating the requirement for tissue debridement around the IPG and proximal leads.

Reduce Revision Complications

By maintaining a healthier pocket (healthy, vascularized, immune competent tissue closer to implanted device) during the lifetime of the IPG, Hylomate Pouch may reduce pocket complications occurring after revision such as hematoma and infection.

Easy to Implant

Hylomate Pouch is an extremely soft and supple device providing surgeons with an ideal material to insert into the surgical pocket.

Example of medical devices incorporating implantable pulse generators

Cardiac Implantable Electronic Devices
  • Pacemakers
  • Implantable Cardiovertor Defibrillator
  • Cardiac Resynchronisation Therapy
Implantable Neurostimulators
  • Vagus Nerve Stimulators
  • Spinal Cord Neuromodulators
  • Deep Brain Stimulators
  • Sacral Nerve Stimulators
Hylomate Pouch is under development and is intended  to  stabilize  the  generator  implant  pocket  around  cardiac  implantable electronic devices or implantable neurostimulators, by providing a physical barrier between the soft tissue and the surface of device.

The additional benefits of the CellSense features on the surface of the device, through reducing fibrotic tissue build-up, may facilitate revision surgery and subsequently reduce complications associated with device revision surgery such as infection and hematoma.

Long term preclinical studies have shown the effectiveness of Hylomate Pouch when combined with IPGs, with significant reductions in the thickness of the surrounding fibrotic tissue, and the ease in which the IPG can be explanted without the need for tissue debridement. Full details of the results can be found here.

First Prize Innovation Award 2019

Pocket Health for Implantable Pulse Generators

Hylomate Pouch is in the final stages of validation and will be submitted shortly for FDA clearance. Hylomate Pouch is not currently available for sale in the US or EU.