Medtronic Approval: Prestige Artificial Neck Disc

Prestige Website:

http://www.prestigedisc.com


Research and Study info:

http://www.prestigedisc.com/pages/cl..._research.html
Some key findings of the PRESTIGE® Cervical Disc clinical trial include:
• At the 12 and 24 months follow-up points, the PRESTIGE® Cervical Disc patient group reported more improvement in their neck pain and a greater ability to go about their daily activities than the fusion control group.
• Patients receiving the PRESTIGE® Cervical Disc maintained sagittal (front and back) angular motion averaging more than 7 degrees in the normal physiologic range of motion. Pre-operatively, the PRESTIGE® Cervical Disc group had a mean angular motion of 7.55 degrees, which increased to an average of 7.59 degrees at 12 and 24 months post-operatively.
• On average, patients receiving the PRESTIGE® Cervical Disc had a median return to work that was 16 days faster than those in the ACDF treatment group.
• Patients in the PRESTIGE® Cervical Disc group experienced no implant failures or migrations.
• Fewer patients in the PRESTIGE® Cervical Disc group required secondary surgical procedures than those in the ACDF investigational group.

MEMPHIS, Tenn.-(Business Wire)-July 17, 2007 - Medtronic, Inc. (NYSE:MDT) announced today that it has received U.S. Food and Drug Administration (FDA) approval to market the Prestige(R) Cervical Disc, the first artificial disc commercially available in the United States for use in the neck.
The Prestige Cervical Disc gives some patients who suffer from degenerative disc disease, which can cause intolerable neck and/or arm pain, the potential to preserve motion at the treated level, as well as offer pain relief and function. Typically, a traditional motion-limiting spinal fusion procedure is indicated for these patients.
"As an active mom and an amateur triathlete, the Prestige Disc gave me back my life," said Stacey Brickson, a patient enrolled in the clinical study from Madison, Wis. "I had so much pain and disability from an auto accident that I could not even lift my head off a pillow before I got the Prestige Disc, and I was too active to even think about a spinal fusion," she added.(a)
As part of the approval conditions, Medtronic has agreed to conduct a seven-year post approval study to evaluate long-term safety and effectiveness. Medtronic is also going to perform a five-year enhanced surveillance study.
In the largest study ever completed in the cervical spine involving 541 patients, results showed that the Prestige Cervical Disc had superior outcomes in neurological success, as well as overall success, a measurement that includes several safety and effectiveness outcomes, when compared to spinal fusion. The study also showed equivalent Neck Disability Index measures and fewer revision surgeries for patients who received the Prestige Cervical Disc. Post-operative examination of Prestige Cervical Disc patients showed that they had a statistically superior overall neurological success rate at 24 months.
"The patented ball-and-trough of the Prestige Cervical Disc is designed to permit motion at the treated level," said J. Kenneth Burkus, M.D., an orthopedic surgeon at the Hughston Clinic in Columbus, Ga. "Now patients suffering from cervical degenerative disc disease (DDD) have an alternative to motion limiting spinal fusion."
The Prestige Cervical Disc is designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Currently, the most common form of surgery for treating cervical degenerative disc disease (DDD) is an anterior cervical discectomy and fusion. More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots and to implant an interbody graft and metal plate to rigidly fuse the vertebrae together.
The Prestige Cervical Disc is designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Currently, the most common form of surgery for treating cervical DDD is an anterior cervical discectomy and fusion. More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots and to implant an interbody graft and metal plate to rigidly fuse the vertebrae together.
The Prestige Cervical Disc underwent a prospective, multi-center, randomized clinical trial to assess its safety and effectiveness based on comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients received the Prestige Cervical Disc device while the 265 patients in the control group received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
More information about the Prestige Cervical Disc can be found at www.necksurgery.com or www.prestigedisc.com.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business at Medtronic, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
(a) Individual patient results may vary.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.

[Harrison]

Folks,

I wish I had more positive things to say about Medtronic’s approval of the Prestige artificial disc. I have much to say, but for now, please see the news release, and the topic I posted today here.

As always, your comments are appreciated.

[sidekicker]

Harrison --

Do you know if any of the risks reported for Prestige in that article (higher incidence of cancer development, device migration, need for resurgery, etc.) are present in the other cervical ADRs floating around the world? In other words, does it appear this one is worse than any of the others? How does it compare in those same categories?

Sorry for so many questions, but this is rather dismal news, particularly considering how long these things are taking to get to market in the US.

Thanks.

SK

[Harrison]

SK,

We all wish we had the comparative stats to make decisions like car-buyers do when using Consumer Reports -- but that will have to wait a few years.

In short, I believe the criticisms of the Prestige also apply to other metal on metal designs as well. The same issues of metal wear and resultant charged particles are thought to present a risk. Sure, other discs may have different designs, with more or less wear; but the risks remain.