How PressEven help you?

24 Dec 2020

Device description

PressEven augmented patch systemt is consisting of a biodegradable pouch-type patch and a PEEK augment. The patch is a sterile implantable and biodegradable pouch-type surgical mesh, it is comprised of collagen which is manufactured from porcine skin and designed to provide mechanical support for weaknesses and deficiencies in soft tissue. The implantable biomaterial is a resorbable extracellular matrix scaffold that will remodel into the body through cellular infiltration, capillary growth and integration by surrounding host tissue. The augment is an accessory to provide the patch a better maneuverability, the shape is designed to be more fitting to tendon footprint and provide even pressure distribution. The augment will be placed in the pouch-type patch, two holes are designed on the augment for letting suture anchors to pin through it and fix the tendon or the soft tissue needed to be fixed.

The device (“Device”) is an implantable device intended to be used for rotator cuff repair surgery. The Device is comprised of 1) PEEK suture anchor with non-absorbable sutures, 2) a PEEK augment (“PressEven”), and 3) a dual-layers porcine dermal patch (“CollaGrowth”). The dual-layers CollaGrowth is designed to provide a pocket space to encompass PressEven augment, and to be fixed together with suture onto the repaired soft tissue during an arthroscopic or open surgery. The design allows the PressEven augment to enhance the reattachment of the tendon to bone surface by providing even distribution of tension, while the porcine patch can augment the fragile tendon and collagen matrix material provides a scaffold for healing.

The PressEven augment has a butterfly-wings shape whose biconcavity minimizes medial tendon perfusion hindrance and improves lateral geometric fit. Bilateral butterfly wings can grasp rotator cable (thickened tendon) to improve the stability of the construct. CollaGrowth patch is made from porous porcine dermis and processed by supercritical Carbon Dioxide (scCO2) fluid, which minimizes residual DNA and preserves structural integrity of collagen scaffold. ScCO2 process has little effect on the mechanical strength and natural porosity of the material, which is beneficial for the healing process. The two layers of the patch are sealed at the edges with a drying process, creating a pocket for insertion of the PressEven augment. The Device will be supplied sterile, for single-use only, and packaged in a kit consisting of the components mentioned above.

The Device will be designed to be used in typical rotator cuff repair surgeries, One medial row anchor and one lateral row knotless anchor will be inserted at the medial side of the footprint where the tendon was originally attached to the bone surface. The sutures are tied through the Device outside the body, and the Device is inserted through the access port into the joint. Then the sutures are passed through the tendon and pulled laterally to reattach cuff tendon to footprint. Finally, sutures are fixed into the bone to the two knotless anchors. The Device compresses the tendon back to the bone, providing even pressure distribution and matrix material support for healing.