A 5-year review of approved cardiovascular medical devices: are women and ethnic minorities adequately represented?




Background


Different demographic subgroups may have different prevalence, diagnosis, disease progression and treatment outcomes for some diseases. Although cardiovascular disease (CVD) is the number one killer of women, women have historically been underrepresented in cardiovascular clinical trials (CVTs). To accurately assess sex differences in the safety and efficacy of medical devices, it is necessary to have representation of both sexes in clinical trials to allow for sex-specific analysis. The purpose of this study was to assess the participation of women and ethnic subgroups in CVTs submitted in support of medical device premarket applications (PMAs) approved by the US FDA from 2005 to 2009.




Methods


All CVTs in approved PMAs approved from 2005 to 2009 were reviewed. Descriptive analyses of the study participants’ ethnicity and sex were tabulated. Demographic data from PMAs were analyzed in 12-month intervals to detect any notable trends in the rate of women’s and ethic subgroup’s participation.

Only gold members can continue reading. Log In or Register to continue

Related posts:

  1. Coronary stenting with MGuard: extended follow-up of first human trial
  2. Understanding the impact of drug-eluting stent on vascular function and the nitric oxide pathway genes using a pig coronary artery stent implantation model
  3. Statin improves outcome of patients presenting with first acute myocardial infarction
  4. Risk factors and impact of contrast left ventriculogram on incidence of contrast-induced nephropathy: is left ventriculogram really necessary?

Stay updated, free articles. Join our Telegram channel
Tags:
Nov 16, 2017 | Posted by in CARDIOLOGY | Comments Off on A 5-year review of approved cardiovascular medical devices: are women and ethnic minorities adequately represented?

Full access? Get Clinical Tree
Get Clinical Tree app for offline access