PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 253 records · Page 14Linked to original sources

Surgically implanted devices: ethical challenges in a very different kind of research.

Research on surgically implanted devices not only can raise issues familiar from drug studies, but also can raise special challenges. This article suggests some ways in which device trials can raise distinctive ethical issues. The AbioCor artificial heart trial is used as an example. Although this particular trial should not be deemed typical of surgically implanted device studies, it can highlight some particularly significant methodologic and ethical features.

Clinical Trials as Topic↗

First clinical use of the redesigned HeartMate II left ventricular assist system in the United States: a case report.

Axial flow ventricular assist devices show great promise as a potential treatment for patients with end-stage heart failure. The HeartMate II system, redesigned on the basis of initial clinical experiences in Europe, is now in clinical trials in the United States. We report on the 1st use of the newly redesigned HeartMate II in the United States. The system has unique features, which include an accurate flow estimator and the ability to automatically detect and correct excessive left ventricular unloading. The new design also incorporates changes in the texturing of the blood-contacting surfaces to prevent thrombosis. The implantation technique and configuration are similar to those of the HeartMate XVE LVAS and require a median sternotomy for access. The 1st patient to receive the device in the United States has had an uncomplicated perioperative course and now awaits transplantation.

Adolescent↗