PubMed Health⌕ Search

PubMed · 12027133

Current options for mechanical heart technology.

Abstract

Heart transplantation remains the treatment of choice for end-stage heart failure despite limited donor availability and allograft durability. Artificial heart technology was initially developed as a replacement for transplantation but the initial experience with these technologies was disappointing. The quest for a total artificial heart has largely been abandoned in favor of ventricular assist devices (VADs). VADs have gained widespread acceptance as bridge to transplant and bridge to recovery therapy. After more than a decade of clinical use, several FDA approved device designs have proved effective in treating patients with various causes of heart failure. This review describes the current, clinically available ventricular replacement and assist devices and defines the adult patient populations in which they are useful. The next generation of these devices will soon become available and their clinical utility will likely shape the future direction of heart failure therapy. Ultimately the concept of a long-term total artificial heart may be revisited.

Explore related subjects

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

D A D'Alessandro, V Rao, P L DiGiorgi, Y Naka, M C Oz. Current options for mechanical heart technology.. https://doi.org/10.1111/j.1540-8191.2001.tb01225.x

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

Medical devices; immunology and microbiology devices; classification of fecal calprotectin immunological test systems. Final rule.

The Food and Drug Administration (FDA) is classifying fecal calprotectin immunological test systems into class II (special controls). The special control that will apply to these devices is the guidance document entitled, "Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems." The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.

Device Approval↗

Medical devices; exception from general requirements for informed consent. Interim final rule.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

Device Approval↗