Medtronic Infuse Woes Could be Good News for Other Device Makers

Medtronic’s problems with its <"http://www.yourlawyer.com/search">Infuse Bone Graft product could turn out to be a boost for other device makers. According to an article posted yesterday on SeekingAlpha.com, Wright Medical Technologies and Bacterin International are just two companies that could see sales of some key products take off if Medtronic’s Infuse loses market share.

Infuse is a spine product made from recombinant human Bone Morphogenetic Protein or rhBMP-2, was approved by the U.S. Food & Drug Administration (FDA) in 2002 as a treatment for anterior approach lumbar fusion. However, as we’ve reported previously, Infuse was widely used in off-label procedures, such as cervical spine (neck) surgeries. In July 2008, however, the FDA warned that Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries.

The 2008 FDA warning was just the beginning of the controversy surrounding Infuse. In the most recent chapter, several Medtronic-funded Infuse clinical trials were called into question by a review published this summer in The Spine Journal which charged that the trial downplayed the product’s association with serious side effects, including male sterility, infection, bone loss and unwanted bone growth. At the same time, the journal’s editors criticized Medtronic for failing to disclose that it had paid many of the researchers involved in the trials millions of dollars in consulting fees.

The U.S. Senate Finance Committee has been investigating Infuse for several years, and recently demanded Medtronic turn over records detailing payments made to Infuse researchers. Meanwhile, the U.S. Justice Department is investigating off-label use of Infuse.

There is some evidence that these issues could weigh on Infuse sales, which contribute roughly $750 million in annual revenue to Medtronic. Recently, a Becker’s Orthopedic, Spine & Pain Management Review poll of 10 spine surgeons found that Infuse safety concerns have caused some to use the product less, though most said Infuse is valuable even with the risks.

According to the SeekingAlpha.com article, several smaller companies “could gain significant traction due to Medtronic’s Infuse woes.” They include:

• Bacterin International: Its core product, according to SeekingAlpha.com, is OsteoSponge, which has shown to be equivalent to Infuse in 12-month data, and 24-month data is set to be released over the coming weeks. OsteoSponge has an added advantage of being only 1/3 the price of Infuse.

• BioMimetic Therapeutics: Exactech’s orthopedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis, according to SeekingAlpha.com.

• Wright Medical Group: In addition to hip knee; extremity implants for the hand, elbow, shoulder, foot and ankle implants, Wright manufactures both synthetic and tissue-based bone graft substitute materials.

• RTI Biologics: RTIX prepares human donated tissue and bovine tissue for transplantation that are used in orthopedic, dental and other specialty surgeries.

• Synovis Life Technologies: The company’s products include implantable biomaterials for soft tissue repair, devices for microsurgery and surgical tools.

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