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EDEN ControlCath is used for delivery of drugs that have been indicated for the epidural space.

EDEN ControlCath consists of a flexible catheter, steering handle, and a port for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The port facilitates the connection of syringes to deliver therapeutic agents by physicians as appropriate to their diagnosis. It is supplied sterile and it is for single use.

The EDEN Spinal Fixation MIS System is intended to provide immobilization of the posterior, noncervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The EDEN Spinal Fixation MIS System can be used in an open approach and a percutaneous approach.

The purpose of this special 510(k) submission is to add MIS components and instruments to the previously cleared EDEN Spinal Fixation System. The EDEN Spinal Fixation MIS System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EDEN Spinal Fixation MIS System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI- 4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EDEN Spinal Fixation MIS System. The EDEN Spinal Fixation MIS System will also offer a wide variety of instruments that range from bone awls to occipital screwdrivers. These instruments will be made from various grades of stainless steel with aluminum alloy being used in a few handles. All items are supplied "NON-STERILE" and must be sterilized prior to use. The orthopedic instruments are Class I, 510k exempt, and discussed here for informational purpose only.

The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The EDEN Spinal Fixation System is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion. The EDEN Spinal Fixation System consists of pedicle screws, rods, cross links, and set screws that can be used via percutaneous surgical approach. The components are available in a variety of designs and sizes in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile. The EDEN Spinal Fixation System also offer a wide variety of instrument that range from bone awls to screwdrivers. They are made of various grades of stainless steel and aluminum alloys. All the items are supplied non-sterile and must be sterilized prior to use.

The EDEN Peek Cage - PLIF Type is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involvedlevel(s).This device is to be used with autogenous bone graft. The EDEN Peek Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The EDEN Peek Cage - ACIF Type is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.

The EDEN Peek Cage is offered in various device configurations based on based on surgical approach and patient anatomy, and consist of: Cervical Interbody Fusion Device (ACIF Type) which may be implanted as a single device via an anterior approach. Lumbar Interbody Fusion Device (PLIF Type) which can be implanted Bi-laterally via a posterior approach. - · As a single device via an Anterior approach;(ACIF Type) - · Bi-laterally via a posterior approach:(PLIF Type) The EDEN Peek Cage is made of polyether ether ketone (VESTAKEEP® i4 R) that conforms to ASTM F2026 and they have tantalum markers (ASTM F560) to assist the surgeon for proper placement of the device. The subject devices are offered gamma sterile.