SlimFuse(TM) provides surgeons the flexibility to choose between a rigid, semi-rigid, or translationally dynamic system without additional instrumentation. Compared to traditional systems, slimfuse’s narrow plate width and scalloped cutouts provide improved interoperative visualization. Standard and dynamic, one and two level plates, require only one screw per level.

“Pioneer’s unique low profile plate design reduces the amount of retraction required for plate implantation,” according to Dr. Randy Davis with the Baltimore Washington Medical Center, Glen Burnie, MD. “A smaller wound site reduces the chances of dysphagia, a swallowing disorder, and helps improve a patient’s rate of recovery.”

SlimFuse received FDA 510K clearance in January 2008. The slimfuse System will be available throughout the United States and distributed in Europe through Pioneer’s wholly owned subsidiary based in the Netherlands.

SOURCE Pioneer Surgical Technology, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Actifuse MIS is ideal for use in a range of spine and orthopedic procedures including posterolateral fusion, tumor/bone void filling and acetabular cysts. The applicator facilitates controlled bone graft delivery through flexible 20cm x 0.8cm prefilled cartridges for fast and precise graft placement.

Actifuse Advanced Bone matriX (ABX) is 96% granules and can be placed straight into the operative site without the need to be mixed with blood or bone marrow aspirate.The unique, silicate substituted, calcium phosphate chemistry of Actifuse is a significant advance in synthetic bone graft technology providing:

• An optimized, osteostimulative scaffold that enhances bone formation
• A safe and effective alternative to both autograft and allograft.
• Steady and predictable remodeling by the patient’s own biology over time

Dr. Louis Jenis of The Boston Spine Group commented: “A growing number of less invasive procedures are being performed, reducing the impact of surgery on patients. Actifuse MIS will play a key role in the delivery of high quality bone graft to difficult to access sites and help us to achieve our goal of successful fusion. Actifuse MIS gives me the flexibility to respond to varying volume requirements and the ability to place graft precisely where I need it.”

Further Information:
www.apatech.com

As such it is now approved for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. Degenerative Disc Disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.

While degenerative disc disease is most often treated by more conservative therapies, the condition can often lead to more severe disorders, such as lumbar spinal stenosis (narrowing of the spinal canal) or spondylolistheses (disc slips forward).

“This is an important step for Titan Spine as it gives the surgeon the ability to utilize the Endoskeleton(R) TA as an Interbody Device while taking off the VBR label, as well as the ability to feel comfortable knowing that they now have the option to use the device in a stand-alone setting,” said Steve Cichy, Vice President of Sales of Titan Spine.

The ENDOSKELETON(R) TA is a unique Titanium cage that sits on the strongest portion of the lumbar endplate, yielding excellent resistance to subsidence and expulsion. Coupled with a large open area for bone graft, the device’s acid-etched Titanium surface serves to provide a strong press fit and boney ingrowth.

www.titanspine.com
SOURCE: Titan Spine
Titan Spine, LLC

The Vu aPOD is the first anterior lumbar intervertebral fusion (ALIF) implant with an optional internal SpinPlate to receive FDA clearance. Vu aPOD uses the patient’s cortical bone in the anterior part of the vertebral body as a buttress when engaging the internal SpinPlate, enhancing implant stability.

Theken received FDA clearance to market Vu aPOD in the United States in early July.

“The surgery went very well and the Vu aPOD was simple to use,” states Dr. Gundanna. “The SpinPlate is like nothing I have used before. It reduces any concerns about implant migration,” continues Gundanna. “It truly provides better fixation for the patient.”

The addition of Vu aPOD enables Theken to offer a more complete product portfolio to spine surgeons.

About Theken, a family of companies
The Theken (Pronounced ‘tay-ken’) family of companies Theken Spine, LLC, Theken Disc, LLC, Theken Orthopaedic, Inc. and Therics, LLC (www.theken.com) specializes in pioneering spinal implant technologies that improve spinal surgical techniques benefiting patients as well as surgeons. Theken provides comprehensive product lines that offer surgeons peace of mind through steadfast product reliability and easy-to-use instrumentation. Products include cervical plates, pedicle screws, spacers, degenerative/deformity devices and trauma devices. Theken also leads the market in developing next generation artificial disc replacement technology.

This unique rod features flexural rigidity properties comparable to 5.5 mm diameter Stainless Steel and 6.35 mm Titanium Alloy. Since Cobalt Chrome is compatible with Titanium, surgeons may have more intra-operative flexibility with various rod offerings in one system. Also, the Cobalt Chrome material is more MRI compatible than a Stainless Steel rod.

“The availability of the 5.5 mm Cobalt Chrome Rod in the RANGE system provides surgeons with the flexibility to make intra-operative decisions on rod rigidity after the Titanium screws are implanted. Cobalt Chrome and Titanium are compatible together in the human body and have clinical advantages over Stainless Steel and 6.35 mm Titanium systems, while maintaining the desired stiffness,” stated Dr. Oheneba Boachie-Adjei (New York, NY). “It takes one step away from the surgical planning process and reduces the inventory needed for different spinal deformity situations. This underscores the idea of low profile simple solutions for complex problems in spine care.”

Dr. Raymund Woo (Gainesville, FL) states, “The introduction of the 5.5 mm Cobalt Chrome Rod greatly enhances the versatility of the RANGE system by providing increased construct rigidity while maintaining the low profile that has been a hallmark of the taper-lock implant design. The use of this rod in deformity surgery has greatly improved our multi-planar correction and has nearly eliminated the need for in-situ contouring. The compatibility of Cobalt Chrome with Titanium provides an elegant fixation option without the need for duplicate implants in Stainless Steel.”

Source: K2M, Inc. www.K2M.com.

The TOPS System allows surgeons to decompress and stabilize the impaired spinal segment without sacrificing motion. By coupling traditional approaches with advanced biomechanics, TOPS is setting a new standard for total posterior motion preservation.

The TOPS system is designed to stabilize the spine after decompression without the need for fusion. It consists of two titanium plates connected by a flexible core that’s covered in a polycarbonate urethane sleeve. After decompression, the TOPS device is inserted into the space between the vertebrae. Four tiny screws hold it in place.

Stephen Robbins, M.D. is an Orthopaedic Surgeon at Columbia St. Mary’s Hospital in Milwaukee. He says, after placement of TOPS, patients usually have immediate relief from symptoms. They are able to stand and walk as soon as they get out of recovery. They are out of the hospital in about two days.

With traditional fusion, it takes at least three months for the bones to heal and six months to a year for complete fusion. So rehabilitation is delayed. With the TOPS system, there is no need to wait for fusion to heal. Rehabilitation can begin quickly and patients get back to normal activities very quickly. In addition, the flexible core of the TOPS system enables near normal bending and range of motion in the spine. Robbins is hopeful that will take the pressure off adjacent vertebrae and reduce the risk of future deterioration of disks in upper and lower vertebrae.

Source: Impliant

Impliant’s Tops spine system less-invasive version features a reduced L5 crossbar configuration that the company feels will further reduce tissue retraction and operative time during Tops implantation.

Impliant said that it is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40% of the patients worldwide who undergo fusion surgery and could benefit from a total posterior arthroplasty solution.

Andrew Shepherd, vice president of sales and marketing at Impliant, said: “We are pleased to add this less-invasive option to our Tops family of products. This line extension is a result of input we received from our Tops investigators to help further improve the ease of insertion of the device.”

Source: http://www.impliant.com/

Surgical infections are relatively rare with spinal surgery, but can have serious consequences when they occur. Are there any specific risk factors that surgeons should watch out for?

Answer:

A recent article in the Journal for Bone and Joint Surgery reported a surgical infection rate of 2% with spinal operations. The single biggest risk factor for infection was diabetes, and patients with elevated blood glucose levels pre- and postoperatively were at higher risk. This is in agreement with current understanding of blood glucose levels and bacterial growth.

Other factors associated with increased risk of infection were suboptimal timing of prophylactic antibiotic therapy, obesity and the presence of multiple surgical residents in the operating room.

It can be difficult to control serum glucose levels in operative patients. These findings underscore the need for tight glucose control in diabetic patients and frequent monitoring of blood glucose levels. Administration of prophylactic antibiotics within one hour before the operation and increasing the antibiotic dosage to adjust for obesity are also important strategies to decrease the risk of surgical site infection after spinal operations.

Source:

The Journal of Bone and Joint Surgery (American). 2008;90:62-69.
doi:10.2106/JBJS.F.01515
© 2008 The Journal of Bone and Joint Surgery, Inc.

Is there any evidence of a benefit associated with the midline rectus (MR) over the paramedian lateral rectus (PLR) approach to disc replacement?

Answer:

A recent article in the journal Spine retrospectively analyzed patient outcomes with the midline rectus (MR) and PLR approaches. Radiographically, the PLR approach showed a significantly higher rate of postoperative malalignment in the sagittal plan. Despite this, there was no significant difference in clinical outcomes between the two groups.

What was found to affect patient outcome was the degree of prosthetic displacement. Patients with displacement of at least 5 mm were significantly more likely to have postoperative disability, regardless of the surgical approach, than patients with malalignment of less than 3mm.

The authors suggest that the finding of increased disability with more severe malaligment may warrant use of the MR approach over the PLR approach.

Source:
Spine. 2008 Jan 15;33(2):205-9.Click here to read Links
A comparison of two retroperitoneal surgical approaches for total disc arthroplasty of the lumbar spine.

Facet Solutions, Inc recently completed evaluation of a new total joint reconstruction system . What are the details of this device, and is it available for clinical use?

Answer:

Facet Solutions combined their Anatomic Facet Replacement System (AFRS) with a semi-constrained disc replacement product to create a total joint replacement device for the lumbar spine. The device is a motion preservation system, designed to allow for physiologic movement about the facets and simultaneous replacement the adjacent disc.

“The use of facet replacement in combination with repair of the anterior column of the spine will have dramatic implications on how we treat patients with degenerative diseases of the spine,” stated Mr. Geoff Pardo, President and CEO of Facet Solutions, Inc. “The finite element model shows how properly designed, anatomically shaped implants work in harmony with one another.”

Facet Solutions recently received landmark patent for a combination intervertebral disc-facet replacement prosthesis. Currently, AFRS is approved only as an investigational device in the U.S. The company plans additional clinical trials of the product, but nationwide marketing is not expected to begin for several years.

Source: Facet Solutions (www.facetsolutions.com)