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.
Example of medical devices incorporating implantable pulse generators
Cardiac Implantable Electronic Devices
Implantable Cardiovertor Defibrillator
Cardiac Resynchronisation Therapy
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.