The RENEW Implant is an interspinous process device made from allograft for the treatment of lumbar spinal stenosis. Designed for ease of implant and to provide a more “natural” interference within the spinous process, the company believes that this innovative device will improve outcomes and provide cost efficiencies to hospitals and surgeons alike.
The RENEW Implant is available in six different sizes to accommodate the patient’s anatomy.

The first implant was performed at the Inova Fairfax Hospital in Fairfax, Virginia by Ronald C. Childs, M.D. Upon completing the procedure, Dr. Childs commented: “I am very pleased with this product. The use of the RENEW Implant provides, in my view, a welcomed alternative to the other various interspinous process devices made from synthetic materials presently in the market.”

SOURCE Interventional Spine, Inc.

The device is part of an unparalleled portfolio of mixer and delivery systems, bone cements and needles for both vertebral augmentation (also known as balloon kyphoplasty) and vertebroplasty, widely used to treat the intense pain caused by VCFs.

During vertebral augmentation, a balloon catheter is used to create a void in the collapsed vertebra, helping to allow for controlled and contained cement delivery. The hardened cement creates an internal cast that stabilizes the fracture, thereby alleviating pain in approximately 90 percent of patients.

iVAS is designed with five key features that help promote enhanced procedure efficiency and outcomes:

* The stiff distal balloon catheter provides rigidity for smooth insertion.
* A flexible proximal catheter allows for easy maneuverability.
* The radiopaque markers on the balloon catheter helps facilitate accurate visualization and placement of the balloon.
* The hand drill cuts cleanly through cancellous bone to create a channel for balloon placement.
* Graduation markings on the access cannula assist in measuring needle depth.

SOURCE Stryker Interventional Spine

According to JAMA:
“Rates of surgery for lumbar stenosis declined slightly from 2002-2007, but use of more complex procedures increased substantially. More complex procedures were associated with greater complications, mortality, hospital charges, and other measures of health care use, even after adjustment for patient demographic and clinical characteristics. Age was less predictive than comorbidity or type of surgical procedure.”

So why are doctors performing complex spinal fusion procedures if there are greater risks of complications? Can it be that complex spinal fusion procedures produce better results?

No says JAMA. “Evidence for greater efficacy of more complex procedures for lumbar stenosis is lacking”

Continues JAMA: “It is unclear why more complex operations are increasing. It seems implausible that the number of patients with the most complex spinal pathology increased 15-fold in just 6 years. The introduction and marketing of new surgical devices and the influence of key opinion leaders may stimulate more invasive surgery, even in the absence of new indications. ”

And, shockingly, of course, money seems to play a role here, as opposed to patient health:
“Financial incentives to hospitals and surgeons for more complex procedures may play a role as may desires of surgeons to be local innovators“.

For more information, please see JAMA’s website. Here is a link to the study: http://jama.ama-assn.org/cgi/content/full/303/13/1259

Question:

The developer of coflex technology is Paradigm Spine, LLC. They have recently announced completion of patient enrollment in an Investigational Device Exemption (”IDE”) pivotal clinical study comparing the coflex® interlaminar technology to instrumented posterolateral fusion in the surgical treatment of spinal stenosis. The study is a prospective, randomized and concurrently controlled clinical study involving more than 380 patients at 21 sites within the United States. Though coflex is only now being studied in the US, the coflex technology, has been in use outside the US for over 15 years of clinical heritage outside the U.S., and has been implanted in more than 50,000 patients internationally.

Dr. Reginald J. Davis, Chief of Neurosurgery at Greater Baltimore Medical Center and an investigator in the study explained, “Since the coflex® device is a functionally dynamic non-fusion implant, it will provide spine surgeons with the option of utilizing a less invasive, tissue sparing procedure while affording patients significant pain relief all without having to resort to fusion. I look forward to having the coflex® device as part of the ‘arsenal’ of surgical options for relief of pain due to spinal stenosis.”

Source
Paradigm Spine, LLC
http://paradigmspine.com/

PATHWAY ACIF, with its large footprint, was designed to provide structural support in the disc space while allowing for a generous amount of autograft containment to promote fusion. The spacer is manufactured from PEEK-OPTIMA®, a biocompatible, radiolucent material, and is available in both parallel and lordotic profiles with a wide range of heights.

Source:
CustomSpine (www.customspine.com)
March 24, 2010

The Spyder System is an innovative retractor system indicated for use in the lumbar spine with Aesculap Spine’s S4 Pedicle Screw System. It features a simple and easy-to-use mechanism that offers full adjustability in both the cranial/caudal and medial/lateral directions, in addition to top-loading blades that can be removed intra-operatively without the need to remove the retractor frame during use. The blades and retractor arms are manufactured from X-ray translucent titanium alloy and retract and tilt allowing the ideal field of view with a minimal length skin incision. In addition, the blades are offered in a variety of sizes designed to encourage the surgeon to utilize an ever more localized and less-invasive surgical approach on posterior fusion cases.

“The Spyder Retractor System allows surgeons to transition from their current ‘Open’ surgical technique to an MIS technique at their own pace,” said Chuck DiNardo, President of Aesculap Implant Systems. “Minimally-invasive procedures continue to grow in popularity and the Spyder Retractor System allows all physicians the opportunity to practice MIS and help their patients recover more rapidly.”

Source: Aesculap Implant Systems, LLC
March 23, 2010

If successful, the Biostat System Phase III study could have an extensive, far-reaching impact on the diagnosis and treatment of discogenic chronic low back pain-a debilitating health condition that affects an estimated four million adults in the U.S. annually.

About the Biostat System

The Biostat System consists of BIOSTAT BIOLOGX® Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate discogenic pain by sealing the painful disc disruptions, reducing inflammation, and enhancing tissue repair.

Source
Spinal Restoration
More detailed information about the Biostat System study is available at http://www.clinicaltrials.gov (Study Identifier: NCT01011816).

The DART - Disc Annular Repair Technology
The DART is a simple peek implant that provides for annular repair following a lumbar discectomy procedure. The unique DART design allows for simple implantation, secure retention, and provides distinct advantages over other non-fusion lumbar spinal implants

Source:
Magellan Spine Technologies, Inc.

An estimated 470,000 thoraco-lumbar fusions will be performed in the United States in 2010 to treat spinal disorders. Spine surgeons typically perform these procedures using highly invasive open techniques. The Paramount system gives surgeons a minimally invasive option to place the pedicle screws through a percutaneous tube. Patient benefits may include faster procedures, reduced blood loss, less tissue trauma and postoperative pain, and a shorter hospital stay.

One of the Paramount system’s unique features is its rod delivery system, wherein the rod is already attached to the polyaxial head, helping to streamline the surgical procedure and reduce the number of operative steps for the surgeon. The system also features a novel compression/distraction system and a robust rod reduction system. Additionally, the advanced Paramount screw delivery system uses a proprietary non-cannulated screw design with a K-wire guided tip for accurate screw placement and enhanced screw strength.

Source: Integra Spine