Nuvasive NeoDisc

Nuvasive is manufacturing a Cervical Disc Replacement called “Neo Disc” or “NeoDisc”.   It’s my understanding this replacement disc has been in use in the UK for a few years, but here in the United States it is still undergoing Clinical Trials.

The Neo Disc is much different than previous disc implants as it contains a center core that provided disc absorption properties.

Spinal Kinetics M6 Cervical

M6 is an entirely different approach but also aims to offer multi-dimensional movement via an Artificial Nucleus, Artificial Annuylus, a Sheath and Fixation Plates.

Link: Spinal Kinetics M6-C

The M6-C has some scary looking keels to be sure, but it also looks very rugged and will hopefully stand the test of time.  At the time of this writing I know of no Clinical Studies in the United States so you’ll be heading to Europe if you believe this is your best option.

Which Cervical Implant is Right for You?

There is no correct answer, and you’ll here it time and again… every case is unique.  I like the idea behind the Nuvasive NeoDisc because it looks to be the least invasive and most likely to naturally replicate the movement of a natural disc.  Unfortunately only time will tell how these devices all will work out for the long haul.  Technology is rapidly improving… make the “right” choice and you could enjoy a lifetime of pain free living, the “wrong” choice and you may look forward to revision surgery.  This is the way it is – “It is what it is” and that sucks for many of us, but it also offers hope.   Whatever you choose it’s in your best interests to learn as much as you can (There are many excellent Forums you can research on; my favorite being Mark’s iSpine.org.

Neo Disc Information

Details NuVasive NeoDisc Implant

Cutaway Spinal Kinetics M6-C

– Kevin McKeever
HealthDay
Posted: 2008-04-28 19:05:04

Note: This article was funded by ADR Manufacturer Medtronic, maker of the FDA Approved prestige Cervical Artificial Disc. The real cost of surgery is not just in the upfront expenses.

MONDAY, April 28 (HealthDay News) — Treating cervical degenerative disc disease by surgically implanting an artificial vertebrae onto one’s spine may cost more initially than a traditional disc fusion operation, but it saves the patient almost $6,000 within two years, according to a new study.

The cost savings is primarily from the patient’s ability to return to work sooner after surgery and his or her need for fewer follow-up procedures.

The study — which was funded by Medtronic, the maker of the artificial cervical disc — was expected to be presented April 29 at the annual meeting of the American Association of Neurological Surgeons, in Chicago.

More than 200,000 procedures are performed each year in the United States to relieve compression on the spinal cord or nerve roots. The most common involves spinal fusion surgery to unify two or more vertebrae in an effort to strengthen the spine and alleviate chronic neck pain.

A year ago, the U.S. Food and Drug Administration approved the use of the first, and to date only, artificial cervical disc in certain cervical spine surgeries. Medtronic’s PRESTIGE disc is a stainless-steel device with a ball-in-trough design, held in place with bone screws.

Researchers conducting a cost-benefit analysis on 541 patients who received either the artificial cervical disc (arthroplasty) or fusion surgery found arthroplasty saved the patient an average of $5,988 over two years following the surgery.

The cost of initial surgery, secondary procedures and medical devices per patient and the average initial procedure cost were both higher for arthroplasty patients than for fusion patients; however, the artificial disc recipients saved long-term, because they needed fewer secondary procedures and returned to work following surgery an average of 38 days sooner than fusion patients.

The return to work alone yielded a gain in work productivity of $6,368, the report said.

“From a societal perspective, the economic benefits associated with these outcomes may offset the increased device costs associated with arthroplasty therapy,” said study presenter Dr. Vincent C. Traynelis, of the University of Iowa, in a prepared statement.

Cervical Spondylosis is commonly referred to as degenerative “Wear and Tear”. It’s a fact of life and part of the aging process, but to dismiss it as just “Something everybody gets” is a mistake. Yes we will all have some degree of Spondylosis, but it should not be taken lightly. Wear and Tear implies it’s just an ordinary everyday thing and we should not worry about it. This may not be the case, because for some of us we are worn and torn way top early in life! Much of the damage done as the result of our own lifestyle choices. If we recognize why we have this disease to a greater degree than is normal for our age, then we can take steps to slow it’s progression.

Unfortunately for most of us, by the time we feel the pain it is often too late! Our Discs erode under the mechanical stresses of everyday life, but are accelerated by our lifestyle choices, posture, stressors, diet, trauma, and genetics. If you live long enough you’ll experience some form of Spondylosis even if you never feel the symptoms.

Lower back degeneration is more commonly felt than neck problems. However many office workers who site at a desk all day, especially in front of a computer screen, can develop Spondylosis from poor postural habits. As a general rule for every 1″ of “Head Forward Posture” the neck receives TWICE the amount of pressure on the discs. Discs in the Center of the neck C5/6 and C6/7 receive the most pressure and are the first to bulge, protrude, and become herniated. Imagine your head as a gallon of milk, in perfect balance on the top of your spine. Move that gallon of milk forward through poor posture and the forces on your spine and soft tissues are amplified to the point where they wear, then eventually break.

Because the discs stop receiving nutrition from a vascular source (There is no separate blood supply to the discs) in most people by the age of 25, healing is a long slow process. Most people are as shocked – as I was – to learn the disc material actually starts to degenerate as early as the second decade of life! In many people damaged cervical discs may experience some resorption, but may never heal completely, ultimately requiring surgical intervention. The current “Gold Standard” of treatment (if conservative treatment and natural healing fail) is called Anterior Cervical Spinal Fusion or Anterior Cervical Discectomy and Fusion (ACDSF).

An Alternative to Cervical Fusion – Artificial Disc Replacement ADR

ADR may be the answer for the “Right” candidates and holds tremendous potential as the technology matures. If you are a candidate for any kind of Cervical Disc Surgery I would recommend you take the time to read the article I’m about to link to published by The American Association of Neurological Surgeons. and written by Physicians from the Department of Neurosurgery, Stanford University Medical Center, Stanford, California : (This is a .pdf file so you’ll need Adobe Acrobat or a PDF reader to view it).

Artificial Discs & Cervical Discetomy – Historical Review of Surgical Anthroplasty

Note: Anthroplasty is the term used to describe replacement of a joint

This article is reproduced in whole for the education of all people with neck pain. No intent is made to violate copyright or gain commercially from the republication of this article. For more information we recommend you visit AANS.ORG This article was published in 2004, and at the time of this update in July 2008, 2 ADR’s (The Prestige ST and Prodisc-C) have been FDA Approved for use in the United States of America with additional approvals pending for new devices currently undergoing clinical trials. I will make additional posts with links to ADR information in both the Neck and Back Pain Categories.

In the above article you will learn about all the Artificial Surgical Disc options in clinical trial as of Summer 2005. The PCM (Porous Coated Motion) from Cervitec looks promising, but has not been FDA approved yet.

Artificial Discs are the wave of the future as they preserve the motion of the disc. Remember the goal of Cervical Fusion is not to make the disc a rigid piece of bone, it’s to decompress the spine – taking pressure off the nerves, to relieve the pain and prevent neurological damage. Unfortunately there are many complications to fusion that arise later. Artificial discs may be the answer, especially in light of the fact that nearly 25-30% of all fusion patients will require further surgery within 10 years according to this article. Read the article and get yourself up to speed on cervical surgical options.

Quick Definitions to help you understand the Surgical Terms:

• Autograft – Patients own bone (Usually taken from the hip)
• Allograft – Donor bone from cadaver
• Arthroplasty – Complete replacement of a joint
• Arthrodesis (Spinal Fusion)

Autograft Cons: Chronic pain from donor site (Usually your hip), Infection of donor area, Hip fracture, Bleeding, Damage to the lateral femoral cutaneous nerve resulting in loss of sensory sensation to the front of the thigh.

Allograft Cons: Slower to heal in multi-level fusions often necessitating the use of anterior plating. Theoretical risk of transmission of infection from a donor.

ADR Resources:

Global Patient Network – Run by Mark Mintzer both a patient advocate and a patient who has received ADR placement.

iSpine.org – iSpine is a sister site to Global Patent Network and offers the most informative ADR Discussion Forums.

Degenerative Spine Disease Explained – Article published by the University of California San Diego Neuroradiology Department.

FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

Issued: July 1, 2008

Dear Healthcare Practitioner:

This is to alert you to reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. Note that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.

The following information provides the adverse events reported to the FDA, the risks associated with the use of rhBMP products in the cervical spine, recommendations for mitigating those risks and the current regulatory status of rhBMP products in the U.S.

Public health concerns: Adverse events and risks to health

FDA has received at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. Severe dysphagia following cervical spine fusion using rhBMP products has also been reported in the literature.

Anatomical proximity of the cervical spine to airway structures in the body has contributed to the seriousness of the events reported and the need for emergency medical intervention. The mechanism of action is unknown, and characteristics of patients at increased risk have not been identified.

Most complications occurred between 2 and 14 days post-operatively with only a few events occurring prior to day 2. When airway complications occurred, medical intervention was frequently necessary. Treatments needed included respiratory support with intubation, anti-inflammatory medication, tracheotomy and most commonly second surgeries to drain the surgical site.

Mitigating the risks

Since the safety and effectiveness of rhBMP for treatment of cervical spine conditions has not been demonstrated, and in light of the serious adverse events described above, FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

Patients treated with rhBMP in the cervical spine should know:

• the signs and symptoms of airway complications, including difficulty breathing or swallowing, or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area
• that they need to seek medical attention immediately at the first sign of an airway complication
• that they need to be especially watchful 2 -14 days after the procedure when airway complications are more likely to occur

Regulatory Status of rhBMP

FDA has approved the use of two rhBMPs for well-defined medical conditions in limited patient populations:

• rhBMP-2 (contained in InFuse Bone Graft) has received premarket approval for fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one level from L₂-S₁ and for healing of acute, open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury. rhBMP-2 is also approved for certain oral and maxillofacial uses.
• rhBMP-7 (referred to as OP-1 and contained in OP-1 Implant and OP-1 Putty) has received humanitarian device exemption approval as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. It is also approved as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.

Both rhBMPs are contraindicated for all uses in patients who are skeletally immature (<18 years of age) or pregnant, and in those with a known hypersensitivity to the specific rhBMP, bovine Type 1 collagen or to other components of the formulations.

Reporting to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility.

Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

To report your experience regarding the devices in this Notification, please use MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-332-1088; by FAX at 1-800-332-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787.

If you have questions about this notification, please contact Julia Marders, RN, MS, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by Fax at 240-276-3368, or by e-mail at phann@cdrh.fda.gov. You may also leave a voicemail message at 240-276-3357, and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet at http://www.fda.gov/cdrh/safety.html. You can also be notified through email on the day the safety notification is released by subscribing to our list server. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.

Sincerely,

Daniel G. Schultz, MD
Director
Center for Devices and Radiological Health
Food and Drug Administration