A Last Gasp for Stryker with OP-1? Not Likely.

Article preview reprinted from IN VIVO -  April, 2009   

Few were surprised when an FDA advisory panel recommended against approving Stryker's OP-1 device for spinal fusion. Plus, given the recent focus on off-label use of orthobiologics, OP-1 was not likely to displace its only competitor, InFuse. That said, the off label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.

Article preview reprinted from IN VIVO - April, 2009   

Given the pointed tone of its advance questions, few were surprised when on March 31, an FDA Orthopaedic and Rehabilitation Devices Advisory Panel recommended 6-1 against approving Stryker Corp.'s OP-1 Putty (recombinant human BMP-7 in a bovine collagen and carboxymethylcellulose matrix) for spinal fusion. The news was unremarkable in several ways. Stryker management and shareholders are more concerned these days with the outlook for its MedSurg business because of reduced hospital capital expenditures nationwide. Plus, given recent regulatory and policing actions around off-label use of orthobiologics, OP-1 was not likely to contribute much to earnings nor displace the only competitor, Medtronic Sofamor Danek's InFuse (BMP-2). That said, the off-label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.

With hindsight, it's fair to say that OP-1's fate was sealed some time ago, when Stryker executed studies of the product designed to show superiority when compared with the use of autograft bone in patients with nonunion long-bone fractures (turned away by the FDA in 2001, see "Stryker Misses the Goal with OP-1," IN VIVO, February 2001 and later in posterior lateral spine fusions (PLF, the subject of the March 2009 advisory panel review). It continued to run with that older study design despite the fact that OP-1 could have been approved in a less stringently powered trial--which of course would have meant starting fresh, at considerable added cost. With respect to the PLF indication, Stryker modified its primary end point several times during the PMA review process; and after OP-1 failed to meet its efficacy end point under the original study design, it then tried to establish non-inferiority to autograft, partly by arguing that an imaging analysis skewed the success rate using OP-1. Even so, the advisory panel viewed OP-1 as not as good as autograft.

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Companies mentioned in this article:

Medtronic Inc.

Medtronic Sofamor Danek

Stryker Corp.


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