SPECIAL NOTICE
B -- Drug-eluting stent population follow-up study
- Notice Date
- 5/13/2003
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-223-03-6050
- Response Due
- 5/28/2003
- Archive Date
- 6/12/2003
- Point of Contact
- Susan Gane, Contract Specialist, Phone (301) 827-7166, Fax (301) 827-7103, - Paul Scarborough, Contract Specialist, Phone (301) 827-7168, Fax (301) 827-7103,
- E-Mail Address
-
sgane@oc.fda.gov, pscarbor@oc.fda.gov
- Description
- The Food and Drug Administration (FDA) Center of Devices and Radiological Health (CDRH) intends to award a contract to the American College of Cardiology (ACC) for the project entitled ? Drug?eluding stent population follow-up study. The mission of the Center for Devices and Radiological Health is to promote and protect the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products. In fulfilling this mission, it is important to use the most extensive health data available to monitor the postmarket safety and effectiveness of new devices and technology. Clinical trials conducted premarket are necessary to show the safety and effectiveness of a new device. However, data on the long-term follow-up of patients may be limited. Due to the short-term nature of much premarket clinical data, long-term postmarket data are essential to monitor the safety and effectiveness of devices in the clinical setting. Limited follow-up of the premarket studies may leave unanswered questions as to the experience of devices over time. CDRH is interested in collaborating with the ACC to study the long-term follow-up of patients who have undergone percutaneous coronary interventions. The main objectives of this study would be to gather information on the prevalence of use of various devices in coronary interventions. Information will be collected on factors such as patient demographics, cardiac risk factors, coronary revascularization, and angiographic findings. In addition, this study should describe possible long-term device-related adverse events such as aneurysm, thrombosis, MI, and malapposition. The ACC should provide a proven, independent mechanism by which to collect long-term patient data. This institution should have a mechanism where the data are comprehensive and collected nationally, from multiple centers. The statutory authority for this action is 41 U.S.C. 253 ? 1 as set forth in FAR 6.302. The closing date of this announcement is May 28, 2003. The NAICS is 541990.
- Place of Performance
- Address: 5630 Fishers Lane, Rockville, Maryland
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN00322968-W 20030515/030513213330 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |