SWEDEN

Nobel Biocare refutes criticism concerning its teeth-in-an-hour dental implant

Nobel Biocare refuted criticism voiced by Swedish scientists, saying its implant product `teeth-in-an-hour` is a scientifically proven concept with high success rates. The Swiss-Swedish implant maker said that one of its `ongoing studies with 19 patients and a total of 118 implants shows that after three years, 96.3 pct of all implants still function`. The complete report will be available in April, it said. The group`s statement came in reaction to a study by Sweden`s Karolinska Institute published on Saturday

`Teeth-in-an-Hour` may carry more complications than conventional methods

Swiss-Swedish Nobel Biocare`s Teeth-in-an-Hour implant system may carry more risk of complications than conventional methods, an abstract of a study by Sweden`s Karolinska Institutet showed on Saturday. The study examined 31 patients treated using the method, which uses computer modeling to reduce implant installation time and showed that complications such as the loss of fixtures and the need for adjustments arose for nearly a third. Nine percent of the 175 fixtures examined were lost, said Bjorn Klinge, professor of periodontology

Sweden`s MPA restricts sale of NobelDirect and NobelPerfect

The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products.The MPA decision directs Nobel Biocare to clearly describe possible causes for the breakdown of the jawbone in the instructions for use and training programs. In addition, the company must describe how the risk for breakdown can be avoided. In sales and promotion information and instructions for use, the company shall indicate the user

Nobel Direct – too risky to use except with `great care`

Sweden`s Medical Products Agency has made a preliminary finding that Nobel Biocare AG`s dental implant Nobel Direct, is too risky to use except with `great care`. The regulator said it will over the next few weeks come to a final view on Nobel Direct and what eventual warnings will be attached to the implant. The agency issued its statement after investigating the results of Nobel Biocare`s own two year study and said this study was not based on a representative

Cresco(r) – Passive fit on screw-retained implant bridges

Astratech has released their Cresco(r) system for ensuring passive fit on screw-retained implant bridges. This system allows for up to 17 degrees of angle correction for screw-retained bridges using bendable wax tubes giving maximum flexibility in terms of being able to compensate for angled implant placement when bone quality and quantity are poor. Using a Cad-Cam-like milling machine corrects the casting distortion of prosthetic superstructures to a very high degree of precision. The majority of implant systems are supported.

NobelDirect – Verdict delayed

Sweden`s Medical Product Agency (SMPA) has announced it will delay its final verdict on the safety of Nobel Biocare AB`s dental implant NobelDirect, which is alleged to cause bone-loss, until November. The agency cited a delay in the release of Nobel Biocare`s two-year follow-up study as being responsible. Two Swedish dentists in May 2005 alleged that the product is causing bone-loss, prompting investigations by the heathcare authority.

NobelDirect – Analysts` Report on Bone Loss Controversy

Merrill Lynch and UBS have released stock research reports regarding Nobel Biocare`s NobelDirect implant design. Several recent studies suggest more than 3mm of bone loss in 14-55% of patients. An expert panel advising the Swedish Medical Products Agency on the safety of the NobelDirect implant has responded to a recent Nobel Biocare rebuttal letter in a critical manner. The Merrill Lynch analyst suggests a NobelDirect withdrawal may be ahead.

Nobel Biocare`s Groovy Implant Surface

Nobel Biocare has introduced an improvement to their Ti-Unite Surface. By placing micro grooves on the surface they claim to increase the implant stability by up to 30% thereby allowing for more rapid bone formation. This surface improvement takes a mechanical approach to increase Bone-to-Implant Contact as opposed to the chemical surface modification`s introduced by Astra (Osseospeed) and Straumann (SLAtive), their main competitors.

12