News: July 24, 2007

Congressional Scrutiny of the 510(k) Process. FDA legislation recently
passed by the House and Senate reauthorizing the medical device user fee
program must be reconciled before it can be signed into law. A
provision in the House, but not the Senate version of the bill, requires
completion of a GAO study of the 510(k) premarket notification process
within a year. Consumer groups, notably Public Citizen and the National
Research Center for Women and Families, have pushed for public scrutiny
of this process due to concern that substantial equivalence
determinations short circuit gathering more safety and effectiveness
data, especially for Class III devices that would normally require a
PMA. Industry representatives worry that statutory changes to the
510(k) process might take place along with the 2012 reauthorization of
user fees. Whether the House provision for a GAO study will survive
into law will be known very shortly. The user fee program expires on
September 30, therefore, reauthorization must be accomplished before the
month-long Congressional recess in August. Additional information is
available at www.thegraysheet.com (paid subscription service).

First of a Kind - Cervical Disc Approved by FDA. The Medtronic Sofamor
Danek Prestige Cervical Disc has been approved for marketing. It is the
first artificial cervical (neck) disc for the treatment of cervical
degenerative disc disease, one of the most common causes of neck and arm
pain. A diseased or bulging intervertebral disc previously was treated
surgically by disc removal and fusion of the two adjacent bony
vertebrae. The device consists of two main pieces of stainless steel
that articulate against one another with a ball and trough. The
artificial disc is attached to the adjacent vertebrae with bone screws.
Additional information is available at
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01668.html

Smith and Nephew Launches First-in-Class Knee Replacement System. The
new Journey Deuce bi-compartmental knee system may supplant nearly 70%
of total knee replacements. The device replaces only the inner portion
of the thigh and shin bone and the kneecap - the areas most often
affected by osteoarthritis. The cruciate ligaments are left intact. So
far, 200 surgeons have received training with the system. Additional
information is available at www.thegraysheet.com (paid subscription service).

First Molecular-Based Lab Test to Detect Metastatic Breast Cancer
Approved by FDA. FDA has approved a molecular-based laboratory test for
detecting whether breast cancer has metastasized to lymph nodes. The
GeneSearch BLN Assay detects molecules abundant in breast tissue but
scarce in normal lymph nodes. The sentinel node, the first lymph node
filtering fluid from the breast, is the most probable location of
migrating breast cancer cells, and is the best indicator of further
metastases. It is often removed and examined during a first surgery.
The new rapid test can be used intra-operatively, thus assisting in the
decision for a more extensive first surgery rather than waiting for a
second surgery in patients with metastatic disease. In a clinical
trial, the assay showed strong agreement with results from microscopic
examination of the lymph nodes, accurately predicting metastases nearly
88% of the time, and identifying patients without metastases 94% of the
time. While the assay had fewer false negative results, it had slightly
more false positive results. A false negative test result may delay the
needed removal of additional lymph nodes, whereas, a false positive test
may result in a more extensive surgery, putting women at risk of
unnecessary lymphedema and other side effects. Additional information
is available at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01667.html