News: August 02, 2007
FDA Reform Bill May Be Delayed Until September. In “Breaking News From The Gray Sheet,” it was reported that Congress has prioritized the passage of a child health insurance program over legislation that would reauthorize medical device and prescription drug user fees prior to its August 2, 2007 adjournment. Despite the agency’s prior position that this might trigger a reduction in force, FDA did not send out notices of possible lay-offs to employees whose positions are funded by user fees. User fees are set to expire on September 30, 2007. Additional information will be available next week at http://www.thegraysheet.com (paid subscription service).
FDA Issues Guidance on 510(k) Submissions for Devices that Include Antimicrobial Agents. Due to an increase in the use of substances designed to inhibit or kill microorganisms in medical devices, the agency has drafted a guidance document for industry on the type of information FDA would like to see regarding the use of this substance with medical devices. The guidance applies to products used inside and outside the body, such as catheters and gloves. Premarket notifications must include a complete characterization of the antimicrobial agent, including description, sterilization, and biocompatibility information, and performance testing results. Comments on the draft will be accepted up to the end of October. Additional information is available at http://www.thegraysheet.com (paid subscription service).
FDA Panel Meeting Date Set for SyntheMed’s Cardiac Anti-Adhesion Barrier. On September 19, the Circulatory System Devices Panel will consider a PMA for the Repel-CV resorbable surgical anti-adhesion film. This product would be the first approved adhesion barrier specifically for use in cardiac surgery. The study population was 144 newborns requiring staged open-heart procedures spaced between 2 and 8 months apart. Seventy percent (70%) of the barrier group was free of significant adhesions at the second surgery compared to 30% of the control group. Additional information is available at http://www.thegraysheet.com (paid subscription service).
Implanted Cardioverter Defibrillators Prevent Sudden Death from Hypertrophic Cardiomyopathy. Results of a Medtronic-sponsored registry study were reported in the July 25 issue of JAMA. Hypertrophic cardiomyopathy (HCM), a genetic disorder that occurs in 1 in 500 people is a leading cause of sudden death in the young, including athletes, and can cause death at any age. While the appropriateness of ICDs for secondary prevention is not disputed, there is uncertainty as to patient selection for primary prevention therapy. Over a mean follow-up of 3.7 years in 506 patients implanted between 1986 and 2003 at 42 centers in the US, Europe and Australia, 20% experienced at least one appropriate shock for ventricular fibrillation or ventricular tachycardia, including 51 patients who had never had a documented arrhythmia prior to implantation. Of these 51 patients, 18 had received the device on the basis of only one sudden death risk factor. The rates of appropriate shocks for patients with one, two, or three risk factors were 3.83, 2.65, and 4.82 per 100 person-years, respectively. Additional information is available at http://www.thegraysheet.com (paid subscription service).
Innovative Brain Imaging System. The July 2007 issue of MD&DI reports on a novel optical imaging system being developed with a $750,000 grant from the Human Frontiers Science Program. The device technology involves a charge-coupled device and three computers, one each for photo acquisition, stimulation generation, and analysis. Brain activity is converted into orientation maps. The device takes a baseline reading of the cortex, stimulates the brain, and then records changes in and around the stimulated areas, generating orientation maps 30 times faster than conventional techniques. The system is contemplated for predicting brain trauma recovery as well as assisting in surgery. For example, it could be used to define the borders of a tumor or to localize epileptic loci, or to identify functional regions to avoid during surgery. The next step in product development is to transfer the system into intraoperative human imaging. Additional information is available at http://www.devicelink.com/mddi/archive/07/07/024.html.