Medical Device Daily Executive Editor

Med-tech powerhouse Medtronic (Minneapolis) made all sorts of news yesterday.

In order, perhaps, of importance:

The company reported that its artificial cervical disc, the Prestige, received FDA approval. The Prestige Cervical Disc is made by Medtronic Spinal and Biologics (Memphis, Tennessee), and the approval is the first for commercialization of an artificial cervical disc in the U.S.

On the wave of that success, the company yesterday was appearing before the FDA’s orthopedic and rehabilitation devices advisory panel to seek recommendation for approval of a second such product, its Bryan cervical disc system.

The FDA yesterday issued Medtronic a warning letter, citing problems at the company’s Minneapolis plant that makes implantable drug infusion and nerve stimulation devices. The agency said that Medtronic had failed to submit timely reports on adverse events “after becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.”

Approval of the Prestige clearly was the best news for the company since providing it first entry to the artificial cervical disc market in the U.S. It already is selling both the Prestige and the Bryan discs in Europe via CE mark approval.

The company banners the primary feature of the Prestige as the ability to improve motion.

Constructed of stainless steel in “a unique, two-piece ball-and-trough configuration,” the device “is designed to preserve mobility and alignment at the treated vertebral segment,” according to the company. The alternative for patients suffering DDD is anterior cervical discectomy and fusion, which usually results in limiting motion.

The company won an FDA advisory panel recommendation for approval last September (Medical Device Daily, Sept. 21, 2006), and it had projected final approval in the first half of 2007. So the agency’s action is only a bit off that mark.

The FDA panel had given its recommendation, with conditions, including the requirement for post-marketing surveillance and the stipulation that the company cannot claim that the Prestige is superior to spinal fusion, a recommendation that the claim be limited to “non-inferiority.”

The panel also recommended that the FDA limit Medtronic’s use of clinical motion discussions in marketing literature and require more analysis of pre-clinical toxicity.

Still another condition of the panel’s recommendation was that the agency require that the indication be narrowed down to cervical DDD that involves “intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression,” as confirmed by radiological studies.

Medtronic was seeking a claim that the Prestige is superior to surgery, but the FDA declined to endorse that claim. It can only say that the device is “as safe and effective” as surgery, thus perhaps limiting market uptake.

Among the conditions that conditions the company agreed to for final approval is the performance of a seven-year study to evaluate long-term safety and effectiveness and a five-year enhanced surveillance study.

The Prestige was studied in a multi-center, randomized clinical trial to assess safety and effectiveness, based on comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3-C7. Application for the device was based on a study of 276 patients received the Prestige Cervical Disc device and 265 patients in a control group receiving an anterior plated surgical fusion utilizing bone graft and plate stabilization.

The company billed the 541-patient study as the largest ever conducted for an artificial disc for the cervical application.

It said that the results showed that the Prestige 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.

Rick Wise, med-tech analyst with Bear Stearns, issued a note projecting a panel recommendation for agency approval of the company’s Bryan cervical disc, and provide a quick boost to the company’s share price.

He projected that the tandem of approved products would produce only “modest immediate financial impact” but longer-term “are key components’ of the Spine division’s growth strategy.”

More than 200,000 patients in the U.S. opt for spinal fusion for cervical disc problems each year, making the market for this and future devices potentially lucrative.

At an anticipated price of $4,500 per surgical set for the Prestige vs. that of the surgical set for standard spinal fusion (said to run between $3,000 and $3,500), analysts have said that Medtronic will have to make a strong argument for its product in order to foster a healthy sales volume.

But given its initial dominance of the field, the company is expected to offer a very controlled roll-out of the Prestige — and perhaps the Bryan — before other companies pursuing this opportunity join the race.

Winning reimbursement could also be a long road. Nevertheless, Prudential Equity Group has projected that sales for the Prestige could reach $400 million by FY11.

The advisory panel’s analysis of the Bryan cervical disc on Tuesday was expected to focus on a key issue: whether the device is more effective than surgery in treating certain neck injuries. The FDA, in documents posted online, said that the Bryan is just as effective as the current surgical procedure for treating worn out spinal discs.

The company studies claims that the disc is 10% more effective than fusion surgery, but FDA reviewers say further analyses of the data show the device may not be that effective.

About 15,000 people outside the U.S. have already been implanted with the device, according to Medtronic.

Also plaguing the sector are negatives concerning previous approvals of artificial discs for the lumbar region, specifically lawsuits claiming adverse events as a result of implants of the Charité, made by Depuy Spine (Raynham, Massachusetts), the orthopedic business of Johnson & Johnson (News Brunswick, New Jersey).

As to the warning letter from the FDA, the agency asked Medtronic to reply within 15 working days to provide an update concerning corrective actions it would take.

Medtronic released a statement saying that the company has “already implemented changed or programs to address many of the observations noted by the FDA” and that it is working to respond and to “ensure that any additional actions necessary to resolve the concerns are in place as quickly as possible” .

Commenting on the warning letter, Wise judged that “the crux of the deficiencies [focus] on device event reporting, standard operating procedures, corrective and preventative actions, design control, and other administrative shortcomings” rather than deficiencies in manufacturing. Thus he called it the “least bad” of the FDA’s warning letter types and could be resolved in a “reasonably short period of time.”