In the past few weeks we've seen a bunch of ink spilled around the treatment of vertebral compression fractures. While always a controversial topic, it seems the discussion has gotten especially vibrant, culminating in new guidelines released by the American Academy of Orthopedic Surgeons (AAOS). On Monday, AAOS approved and released clinical practice guidelines that recommend against the use of vertebroplasty--a procedure in which bone cement is inserted percutaneously into a fractured vertebra.
Generated by a working group that had completed an extensive review of clinical literature to arrive at an evidence-based conclusion, the guidelines concluded that there was little evidence to suggest that vertebroplasty offers any real clinical benefit. While the literature that informed the guidelines spanned several decades, two major studies which appeared in the same issue of the New England Journal of Medicine in 2009, were especially important to their conclusions. Both of these studies compared vertebroplasty to a sham procedure and found no measurable clinical benefit among patients that received vertebroplasty.
While the guidelines were especially negative towards vertebroplasty, AAOS did not show favor to kyphoplasty either, expressing a weak recommendation for its use in patients. Though this recommendation does at least suggest the therapy may be useful, it shows little confidence that this is the case.
Recent movements on the industry front don't reflect such middling clinical support for these procedures. Only a few days before AAOS published its guidelines, ArthroCare announced that it had received FDA clearance for its Parallax Contour Vertebral Augmentation Device, the second kyphoplasty technology to receive FDA clearance in the past couple of months (CareFusion had a balloon approved in August as reported previously on the Pipeline). After being a single-vendor market for so long, these back to back approvals are a big change, and suggest that industry still sees kyphoplasty as a big growth opportunity.
Next week, members of Technology Insights will be headed to Orlando to attend the annual scientific sessions of the North American Spine Society (NASS), and we will be sure to keep you all abreast of any additional updates to the current controversy over vertebroplasty and kyphoplasty, as well as all other concerns in the spine world. Look for updates here on the Pipeline.
Several years ago, women's health vendor Hologic introduced the concept of 3D digital breast tomosynthesis, a new technology thought to revolutionize the breast imaging specialty by increasing the performance of standard 2D digital mammography. Interest from the health care community immediately sparked, with many experts indicating breast tomosynthesis could ultimately supplant digital mammography as the modality of choice for the screening and diagnosis breast cancer in any setting. Despite its promise, the years came and went, but still no tomosynthesis product. The lack of clinical data, a very complicated FDA reviewal process, unclear indications for use, and myriad other factors were, and still are, to blame. Now, it appears one very important and cumbersome barrier to tomosynethsis development is beginning to budge.
Last Friday, the FDA's Medical Devices Advisory Committee - a group consisting of clinicians, statisticians, patient advocates, and industry representatives - convened to advise the FDA on whether or not to proceed with approval for Hologic's Selenia Dimensions 3D tomosynthesis system. In a 12-0 vote, the panel overwhelmingly, and somewhat surprisingly, came out in favor of the FDA approving the device and moving forward in the pre-market approval (PMA) process. While many radiologists, technologists, administrators, and members of industry anxiously await the final decions from the FDA, last week's panel recommendation to proceed in the formal FDA review process marks a historic first step towards a definitive answer.
Tomosynthesis Inches Closer to Approval with Positive FDA Meeting
While transcatheter valves and the PARTNER trial clearly took center stage at this year's TCT meeting, a host of other clinical trials were presented as well, including the continuation of follow-up on some major drug-eluting stent trials. As a round-up of the conference, please see below for a brief overview of each of the major clinical trials presented at the meeting.