Sofamor Danek increases the size of its Bryan and Prestige Cervical Disc trials, we think.
BY EDITOR, JULY 21, 2003
We have been hounding the overworked folks in Medtronic's investor relations department about last week's Bryan® and Prestige™ Cervical Disc clinical trial press release. Apparently, we were the only people who called with a question. All other Analysts calling in were pre-occupied with defibrillators, drug eluting stents, heart valves, pacemakers, etc. Sofamor Danek increases the size of the clinical trial for a potentially game changing spinal implant technology and they have only received one call in reference to it.
We might have misinterpreted past press releases and articles. However, it appears as though Sofamor Danek has significantly increased the size of its two Cervical Disc clinical trials. Before last week's press release, we read that the two trials were held at 12 centers, then 20 centers, then 25 centers and now, according to last week's press release, 50 centers. Before last week's press release, we also read that the trials would enroll 350 patients. Now, that figure stands at 1,100. It is also possible that the previous articles and press releases were referring specifically to the Bryan, or the Prestige, or even both.
The two artificial discs being studied in the clinical trials are the BRYAN® Cervical Disc Prosthesis and the PRESTIGE™ Artificial Cervical Disc. The Bryan disc is CE Mark approved (as of September 2000) and has been distributed in more than 17 countries outside the United States. To date, more than 1,000 patients have received the Bryan device. The Bryan® Cervical Disc System is a composite-type artificial disc designed with a low friction, wear resistant, elastic nucleus with two anatomically shaped metal plates. A flexible membrane forms a sealed space and contains a lubricant to reduce friction as well as wear and tear. It comes in five sizes. The PRESTIGE™ Artificial Cervical Disc consists of two metallic components designed to act as a pivot point, which allows the spinal segment to undergo a full range of motion.
