Guidance for Industry and FDA Staff – Procedures for Handling Post-Approval Studies Imposed by PMA Order.  FDA issued a new guidance intended to aid sponsors who are subject to clinical post-approval study requirements and to make CDRH’s approach to such studies more transparent.  FDA recommends that sponsors report the status of their post-approval studies using the specific terminology outlined in the guidance documents.  Generally, FDA asks that sponsors submit three copies of their protocols prior to PMA approval, although the final protocol and deadlines will be determined during the PMA review process.  The guidance document outlines the information that FDA recommends be included in any interim reports, which should be submitted every six months for the first two years and annually thereafter until the final post-approval study report is submitted.  CDRH will evaluate the interim post-approval reports within 60 days of receipt based on criteria outlined in the guidance document.  The sponsor’s final post-approval study report describing the study and its results and explaining how it fulfills the post-approval study requirements should be submitted separately.  FDA will evaluate the final study report and inform the sponsor whether or not additional information is required.  In the interest of transparency, some post-approval study information may be posted on the FDA website.  Additional information is available at http://www.fda.gov/cdrh/osb/guidance/1561.html.

AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II.  AGA Medical Corporation, the leader in development of devices to treat structural heart defects, announced that it has received FDA and CE Mark approvals for its AMPLATZER Vascular Plug II.  The device is a self- expandable nitinol mesh occlusion device, which can be introduced in a minimally invasive way through a catheter.  The device is available in a range of sizes, which allow treatment of a wider array of vessel sizes with a single device, increasing overall efficiency.  Additional information is available at http://www.devicelink.com/newsedge/. 

Smith & Nephew Receives Gender Knee System Clearance.  Smith & Nephew, Inc. received FDA clearance for the JOURNEY Bi-Cruciate Stabilized Knee System, the GENESIS II Total Knee System and the LEGION Revision Knee System product lines for gender specificity product requirements, giving Smith & Nephew the widest array of knee replacement products cleared for gender specific attributes.  These products boast anatomic tibial baseplates for both the right and left knees and ensure an anatomically correct fit regardless of gender. Additional information is available at http://www.devicelink.com/newsedge/.  

Medtronic Prestige Cervical Disc Rollout Marks 800 Surgeons Trained to Date.  Medtronic’s Prestige, which received PMA approval on July 16, is the first artificial cervical disc for the neck to receive U.S. approval.  Thus far, Medtronic has trained 800 surgeons on the use of its Prestige cervical disc and plans to continue training 200 surgeons each weekend for several weeks.  FDA approved labeling for Prestige claims superiority to fusion in terms of overall success and neurological status post-procedure.  Although other artificial discs were previously marketed in the U.S., Prestige is the first disc of any kind to receive an FDA labeling claim of superiority.  Medtronic touts Prestige as the first in a series of new product launches coming in the near term.  Other Medtronic devices awaiting FDA approval include the Bryan cervical disc and the Maverick lumbar disc.  Additional information is available at  http://www.thegraysheet.com (paid subscription service).

Patent Rule Limits Applications, Impacting Device Makers’ Filing Strategies.  The U.S. Patent and Trademark office recently handed down a final rule limiting the number of applications a manufacturer can submit for a single invention.  The rule aims to reduce the number of “continuing applications” filed with the PTO.  Currently, continuing applications are unlimited, but effective November 1, each parent application will be allowed only three continuing applications without justification.  Although the overall impact of the rule is uncertain, the medical device industry may feel the rule’s impact more acutely than other industries due to its disproportionate reliance on continuing applications.  Despite the PTO’s justifications for the rule, at least one lawsuit seeking to nullify the rule is already pending.  Additional information is available at  http://www.thegraysheet.com (paid subscription service).

CMS Denies Artificial Lumbar Disc Coverage For Patients Aged 60 And Over. CMS widened its national non-coverage policy for Johnson & Johnson/DePuy's Charité artificial lumbar disc to encompass Synthes' ProDisc and all future products in that category for Medicare patients over age 60. For disabled patients under age 60 who qualify for Medicare, coverage of artificial lumbar discs will continue to be at the discretion of local carriers. CMS says that the FDA-cleared trials of artificial lumbar discs completed to date excluded patients over age 60. The decision also cites the conclusion of the Medicare Coverage Advisory Committee that the evidence supporting lumbar discs for patients over 65 is insufficient. The committee also advised CMS that there is little evidence to support spinal fusion for the elderly population, which is the control therapy in artificial disc trials. Additional information is available at http://www.thegraysheet.com (paid subscription service).

Single-Use, Needle-Free, Lidocaine Delivery System Approved. FDA granted approval of Anesiva's Zingo needle-free, single-use lidocaine delivery system. Zingo gives quick, topical, local analgesia allowing intravenous line placement or venipuncture to begin in one to three minutes. The company foresees future potential Zingo use for delivery of other medications such as insulin, human growth hormone, erythropoietin, calcitonin, and vaccines. Additional information is available at http://www.thegraysheet.com (paid subscription service).

FDA Approves Mobile Mammography System for Improved Access to Breast Care. GE Healthcare, a unit of General Electric Company, received FDA approval for its new mobile mammography product that will improve access to breast cancer screening for millions of women around the world. The mobile Senographe(R) Essential is built on the company's Senographe Essential platform, the next-generation of GE's Senographe Full Field Digital Mammography systems. Additional information is available at http://today.reuters.com/news/articleinvesting.aspx?view=
PR&symbol=GE&storyID=122141+22-Aug-2007+BW&type=qcna.

Personalized Genetic Test Info Added To Warfarin Drug Labeling. FDA will change the label for warfarin to inform physicians and patients about the usefulness of genetic testing before beginning therapy, but the agency will wait for data from ongoing studies of the tests before adding stronger recommendations for the tests. Identifying variants in a patient's CYP2C9 and VKORC1 genes might be one factor in picking an initial dose. CYP2C9 is involved in warfarin metabolism and VKORC1 helps regulate the ability of the drug to prevent blood from clotting. According to studies cited in the labeling, genetic variation is responsible for 30%-40% of the variation in a patient's response to the drug. These studies also show that the prevalence for these genetic markers varies among ethnic groups. For example, the frequency of one important genetic variation influencing warfarin response may be as high as 89% in Asians and as low as 14% in Caucasians. FDA leaders say the labeling change is important to the progression of personalized medicine and pharmacogenomics. "This marks the first time that such pharmacogenomics information has been included with a widely used drug." Additional information is available at http://www.thegraysheet.com (paid subscription service).