Title |
Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review
|
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Published in |
Systematic Reviews, October 2013
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DOI | 10.1186/2046-4053-2-94 |
Pubmed ID | |
Authors |
Julie Polisena, Alan J Forster, Karen Cimon, Danielle Rabb |
Abstract |
Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Members of the public | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 23 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Other | 3 | 13% |
Student > Bachelor | 3 | 13% |
Student > Ph. D. Student | 2 | 9% |
Student > Master | 2 | 9% |
Professor > Associate Professor | 2 | 9% |
Other | 2 | 9% |
Unknown | 9 | 39% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 8 | 35% |
Social Sciences | 1 | 4% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 4% |
Neuroscience | 1 | 4% |
Engineering | 1 | 4% |
Other | 0 | 0% |
Unknown | 11 | 48% |