Printer Friendly Email Article

October 2008 | Web Exclusive


Straumann’s Emdogain gets green light again

Oral tissue regeneration products re-launched in U.S. after re-inspection of Group’s Biora facility in Sweden by the FDA.


Straumann, a global leader in implant and restorative dentistry and oral tissue regeneration, recently announced that the import detention on Biora products in the United States, which has been in place since the beginning of 2007, has been lifted following a re-inspection of the Group’s Biora facility in Sweden by the Food and Drug Administration.

	PRE-OPERATION
	POST-OPERATION

As a result, Straumann can now supply its range of oral tissue regeneration products to dental professionals and their patients in the U.S. again. The company’s U.S. subsidiary is taking orders again for the products concerned—Straumann Emdogain, PrefGel® and BoneCeramic.

As no other countries have been affected by the U.S. import detention, availability elsewhere has been uninterrupted and global sales have continued to develop positively, reflecting the fact that these products help to meet healthcare needs both in tooth preservation and oral bone augmentation.

Straumann Emdogain is an effective therapy that helps to stabilize teeth and improve the outcome of periodontal surgery by regenerating the tissue structures that anchor the tooth. Specifically, Emdogain is used as an adjunct to periodontal surgery as a topical application onto exposed root surfaces, and is indicated for the treatment of intra-bony defects due to moderate or severe periodontitis, as well as the surgical treatment of gum recessions.

“We couldn’t be more excited to have it back,” said Peter Riddell, vice president of marketing for Straumann.

“We were always being asked, ‘When will it be back.’ We have plenty of inventory and now we’re just getting the message out.”

Since its introduction in 1996, Emdogain has been used in more than a million patients worldwide and continues to be a leading product for periodontal regeneration. The wealth of scientific evidence supporting the product continues to grow. In the past 12 months alone, more than 40 new scientific articles have been published in peer reviewed journals, including a systematic review of 18 studies on the treatment of gum recessions. This showed that Emdogain can increase the predictability of surgical outcomes by achieving equal or better root coverage and attachment.

Other recently published studies have indicated that less post-surgical discomfort is reported with Emdogain.

Straumann PrefGel is a convenient gel which is used to remove the smear layer on the tooth surface prior to application of Emdogain. Straumann is now introducing PrefGel in the U.S. in an easy-to-use pre-filled syringe, which has been well received by clinicians in Europe, where it has been available for some time.

For more information, visit straumann.com.