Astra Tech, Inc., announces FDA approval and the availability of OsseoSpeed™

March 10, 2005
Fluoride modification to TiOblast™ surface promotes growth of more bone more rapidly after dental implant surgery

Astra Tech, Inc., the medical device company, has announced FDA approval and the availability of OsseoSpeed™, a unique fluoride modification to the TiOblast™ surface that promotes faster bone growth and improves on the clinically documented TiOblast surface for optimal treatment outcomes in dental implant surgery. OsseoSpeed provides more rapid bone growth during the crucial healing period immediately following implant placement, improving bone growth speed, surface contact area and bonding strength by as much as 30-50 percent over un-modified roughened titanium implants.

"Our research has shown that the fluoride-modified surface leads to faster osteoblast differentiation (the basis of more rapid bone formation) that my be advantageous in sub-optimal clinical situations," said Dr. Lyndon F. Cooper, DDS, PhD, Department of Prosthodontics, University North Carolina at Chapel Hill, School of Dentistry. "More bone growth more rapidly may enable dental professionals to perform implant surgery with greater confidence." Dr. Cooper's research was funded by The AstraZeneca group.

Once the implant is firmly attached to the bone, dental professionals select and place an abutment onto which prosthetic teeth can be attached. The results are replacement teeth that very closely match the patient's original teeth in terms of look, feel and function.

"The Astra Tech Dental Implant System is backed by a 10-year record of clinical and pre-clinical research," said Dr. Clark Stanford, DDS, PhD, University of Iowa, College of Dentistry. "And ongoing studies of the OsseoSpeed surface have demonstrated enhanced qualities compared to other rough implant surfaces in terms of the speed of bone growth, surface contact area, and bonding strength - the primary factors in a successful implant placement."

The OsseoSpeed surface is available in four diameters (3.5, 4.0, 4.5 and 5.0), all of which include internal "double-hex" to provide anti-rotation and allow for convenient indexing of the abutment. To further simplify installation, the carrier is narrower with depth markings which can guide abutment selection and confirm implant depth.

"OsseoSpeed and the other key features of the Astra Tech Dental Implant System provide optimal long-term results in which surgeons and patients alike can have confidence," said Anders Holmén, Dental Medical Director at Astra Tech AB. "We are proud to make this technology available in the United States."

The U.S. market for dental implants is approaching $400 million and is estimated to grow by as much as 20 percent each year for the next five years to an estimated $1 billion in 2011. More than 500,000 dental implants were placed in the U.S. last year.

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