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Market & Industry Briefs

Brief summaries of recent medtech market and industry developments. This month we cover FDA panels' thumbs-down rulings on Styker's OP1-Putty and Therox's SuperSaturated Oxygen Therapy System, a potential curb on payments for negative pressure wound therapy pumps, CMS' review of carotid stenting coverage, and Abbott Vascular move into the second phase of its ABSORB trial for its drug-eluting stent.

Stryker Corp. was handed a big disappointment last month when a Food & Drug Administration (FDA) advisory panel concluded that the company’s OP-1 Putty was "not approvable" for use in posterolateral lumbar spine fusion procedures. Citing problems with the company’s clinical study design and unanswered questions about potential immunologic effects of the product, which contains recombinant human bone morphogenetic protein (rhBMP)-7, the agency voted 6 to 1 against recommending approval. During the panel meeting, some participants pointed out that the product serves an important clinical need by obviating the need to harvest bone graft material in patients undergoing spine fusions. Moreover, there is a large amount of data on the product already, which has been available since 2004 under a Humanitarian Device Exemption for limited use in spine surgery revision patients for whom autograft is not feasible. But these arguments were not enough to sway the panel’s vote.

This is not the first setback for OP-1, which also failed to win FDA panel recommendation in 2007. At that time, the panel requested more data, which the company attempted...

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