Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Device Approval”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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

At least 1,351 records · Page 75Linked to original sources
PubMed1998

Medicare and Medicaid programs; quarterly listing of program issuances--fourth quarter 1997--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during October, November, and December of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1997

Medicare and Medicaid programs; quarterly listing of program issuances; fourth quarter 1996--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during October, November, and December of 1996 that relate to the Medicare and Medicaid programs. It also indicates certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2003

Evaluating devices for treating epilepsy.

PURPOSE: Research into new implantable devices for treating epilepsy is expanding rapidly. Pilot studies suggest sufficient safety and potential efficacy to justify proceeding with larger scale clinical trials. Understanding the challenges presented by these trials, the testing and approval process for implantable devices, and how these differ from requirements for antiepileptic drugs (AEDs) is vital to evaluating when and where these new technologies will fit into the therapeutic armamentarium. METHODS: Important lessons regarding the limitations of uncontrolled pilot studies, patient registries, and how the Food and Drug Administration (FDA) approval process can influence trials are drawn from the implantable device literature. Some discussion of the role of animal experiments is presented, both as justification for investigational device exemptions and their potential role in establishing safety. Clinical trial experience with the vagal nerve stimulator, the first device approved for the treatment of epilepsy, is also discussed. RESULTS: New implantable devices hold great promise for medically refractory epilepsy patients who have no other therapeutic alternative. If effective, they may become a viable alternative to epilepsy surgery or multiple AED therapy in appropriate patients. CONCLUSIONS: The proper evaluation, use, and acceptance of antiepileptic devices will ultimately depend on carefully executed clinical trials that take into account unique aspects of these devices, such as the requirement for surgery, electrode placement, and navigation through FDA-monitored testing and approval.

Animals↗
PubMed2004

Medical device regulation: an introduction for the practicing physician.

Patient care for the practicing physician increasingly relies on medical devices. The U.S. Food and Drug Administration is responsible for the safety and effectiveness of medical devices in the United States. In addition to playing a role in the clinical use of devices, physicians may also participate in their design, production, use, and safety by expressing their need for certain products, by providing practical input and feedback into product design, by participating in device-related research, and by reporting device-related adverse events. Physicians should understand the rules that govern the approved and unapproved use of medical devices as well as device premarket evaluation and approval processes and device postmarket surveillance.

Consumer Product Safety↗
PubMed2006

Abdominal aortic aneurysm-repair devices.

Traditional open aneurysm repair is associated with significant perioperative morbidity. The development of abdominal aneurysm-repair devices has provided a minimally invasive alternative to open repairs. The field of aneurysm-repair devices is burgeoning since the approval of the first device in 1999. A clear perioperative survival advantage and lower perioperative morbidity has been reported by multiple studies. In addition to benefiting the normal risk aortic aneurysm patient, this new technology is making the repair of aneurysms in older patients with high operative risk factors possible. Modifications to devices are introduced rapidly to overcome anatomical limitations and to improve on device-related complications such as endoleaks and migration. Limited long-term outcomes are available for newer devices, and life-long surveillance is still recommended for all patients. Patient selection and preoperative planning are the cornerstones to successful endovascular repair of abdominal aortic aneurysms.

Aortic Aneurysm, Abdominal↗
PubMed2003

Percutaneous arterial closure devices.

Advances in interventional angiography such as covered stent technology and adjunctive anticoagulation and antiplatelet therapy for arterial recanalization have reached the margins of percutaneous application. In these circumstances, compression methods of arterial closure require prolonged compression or long arterial sheath dwell times that increase procedural time, complication rates, and patient discomfort. Percutaneous arterial closure devices offer the potential of rapid hemostasis and shorter times to ambulation and discharge. These benefits have costs, in terms of the price of the devices and complications of their use. A Web search identified approved and pending devices. A Medline search identified device studies that were reviewed to assess the efficacy and complication rates of device-mediated closure versus the gold standard of manual compression. Studies that compared devices were evaluated to determine if any particular device was superior. The arterial closure devices were equivalent to manual compression in the establishment of hemostasis in the diagnostic population. However, complication rates were higher. In the therapeutic populations, the devices were as efficacious as manual compression, without correction of anticoagulation, and the complication rates were similar. No individual device was clearly superior.

Arteries↗
PubMed1997

Interventional cardiology and intracoronary stents--a changing practice: approved vs. nonapproved indications.

Our objective was to document change in stent usage in a single practice over time and to study "off-label" compared to Food and Drug Administration (FDA)-approved indications. Although only two intracoronary stents have been approved by the FDA, the relatively limited approved indications do not account for the dramatic increase in stent implantation. This increase has important implications for patient health care delivery. This study of stent usage in a single center over a 36-mo period included all patients treated with coronary stents at the Mayo Clinic from January 1993-December 1995, and evaluated the relative difference in frequency between "off-label" and FDA-approved indications for implantation. During the 36-mo period of study, 3,614 interventional procedures were done and one or more stents were placed in 25.4% of patients. The proportion of patients receiving stents increased throughout this time: during the first 6-mo period, stents were placed in 6.2% of procedures; during the last 6-mo period, stents were placed in 46.3% of procedures, an eightfold increase. During the final 6 mo, an unapproved device or an unapproved indication for an approved device constituted 59.4% of all stent procedures. In addition, use of the non-FDA-approved adjunctive treatment regimen without warfarin increased from 2.9% in the first 6-mo period of observation to 82.7% in the last 6 mo. The use of stents increased strikingly over a 36-mo period, from 6% to 46% of all procedures. The majority of implantations were performed either for an "off-label" unapproved indication or with an unapproved device.

Angioplasty, Balloon, Coronary↗
PubMed1998

Facilitated vascular anastomoses: the one-shot device.

BACKGROUND: A mechanical system for facilitating vascular anastomosis (end-to-side, end-to-end) is described that enables the rapid construction of nonpenetrated, compliant junctions. The instrument (United States Surgical One-Shot system) simultaneously applies either 10 or 12 nonpenetrating, arcuate-legged titanium clips to everted vessel or prosthetic conduit edges. METHODS AND RESULTS: The instrument has been tested in animals (jugular and femoral vein jump grafts in carotid and femoral arteries, interpositional grafts, 20 pigs) and human cadaveric constructs (saphenous veins to left anterior descending coronary arteries, 20 cases, 5 brachiocephalic access fistulas) as end-to-side constructs. Clipped constructs have equivalent or superior physical properties to control sutured constructs (6-0 polypropylene) as gauged by burst and tensile strength. All studies were performed under Food and Drug Administration Good Laboratory Practice standards, and the device has been approved for marketing by the Food and Drug Administration. CONCLUSIONS: The device enables rapid and reproducible vascular anastomotic constructs with vessels as small as 1.8 mm outer diameter. The constructs are flanged, interrupted, and nonpenetrated.

Anastomosis, Surgical↗
PubMed2003

Total artificial hearts: bridge to transplantation.

The CardioWest TAH was created and initially tested at the same time as the Thoratec, Novacor, and HeartMate devices. It was designed as a permanent artificial heart and was the first-ever mechanical circulatory device to be used as destination therapy. Twenty years have passed since that early experience. Pneumatic technology is still current and being developed as in existing or new implantable Thoratec VADs the pneumatic HeartMate, and the Abiomed BVS 5000 pumps. Portable pneumatic drivers have been available since 1982, and in recent times have allowed discharge to home of substantial numbers of patients, thus reducing the length of hospital stays and making mechanical device support less expensive to society and more tolerable to patients. Within months, a portable driver for the CardioWest will be available. The documented benefits of the CardioWest TAH include rescue of: critically ill patients with advanced heart failure; patients with biventricular failure especially those with significant right heart failure, elevated pulmonary vascular resistance, or pulmonary edema; patients with renal or hepatic failure secondary to low cardiac output; patients with massive myocardial damage such as those with post-\infarction VSD or irreversible cardiac graft rejection; patients with mechanical valves or native valve disease; and patients with intractable arrhythmias and heart failure. High device outputs with restoration of normal filling pressures result in high perfusion pressures that have led to dramatic recoveries, convalescence, and return to levels of activity compatible with normal life. The average device output with the CardioWest TAH is higher than any other approved or investigational device. The reason for this resides in design simplicity this device has the shortest and largest inflow pathway. Stroke, in the authors' own series, is rare with a linearized rate of 0.068 events per patient year. If the experiences of La Pitie and the University of Arizona are combined, there has been one stroke in 25 patient years (0.04 events/patient year). Serious infections have been rare (12% of patients). No clinical mediastinitis has occurred. Drivelines have healed in tightly and never caused an "ascending" infection. There has not been a case of device endocarditis. Using a broad definition of bleeding, including takeback reoperation for bleeding, bleeding more than 8 units in the first postoperative 24 hours or 5 units over any other 48-hour period, a 25% to 36% incidence has been documented. No cases of fatal exsanguination have resulted, as there have been with the HeartMate. The incidence of bleeding as an adverse event is about 17% lower than the rate reported for the HeartMate VE LVAD, and it is about the same as that reported for Novacor and for Thoratec. Implantation of this device is relatively easy and often done (with attending help) by the authors' residents. If one follows the guidelines for fitting the device, and takes the recommended advice for implantation, hemostasis is excellent and restoration of immediate cardiac function with high flows is nearly automatic. Use of a neopericardium of 0.1 mm EPTFE at the time of implantation assures atraumatic and relatively quick re-entry for transplantation and prevents the normal inflammatory mediastinal reaction that might be desirable in a destination application. In selected patients the CardioWest TAH is the device of choice for bridge to transplantation. When a portable driver becomes available, out of hospital management of CardioWest TAH patients will be feasible and consideration of use of this device for longer term applications, (e.g., "destination therapy,") will be reasonable. A wearable driver, even smaller than a portable, will improve quality of life and expand the patient population that may be therapeutically served with this system. In short, the CardioWest TAH has come nearly full circle. It was first used as a destination device. It has since been used as a bridge to transplantation in nearly 200 patients as the Jarvik-7/Symbion TAH and, since 1993, in over 225 patients as CardioWest. The results have improved with time. Thromboembolism and infection rates have been competitive with currently available devices. Device reliability and durability have been excellent. Survival rates have been very high in a group of perhaps the sickest patients to be supported with any pulsatile device. Pneumatic technology has improved with portability and miniaturization, and there is reason to believe that it will become even better. Application of modern manufacturing techniques to this very simple device raises the possibility of significant manufacturing cost reduction, in an era of prohibitive cost for other devices. All of this establishes the CardioWest as a valuable device for any program that is seriously interested in end-stage heart disease and a likely device for permanent use in appropriately selected patients.

Anticoagulants↗
PubMed2001

Left ventricular assist devices and the slippery slope of ageism.

The use of left ventricular assist devices is growing each year, as is the size of the United Network for Organ Sharing cardiac waiting pool. Notably, the geriatric waiting pool (age 65 and older), although small, is growing each year and this growth is predicted to increase as geriatric population projection curves soar. While left ventricular assist devices have clinically proven benefit, their use in geriatric patients raises ethical issues. Where these devices are currently not approved as destination therapy, their use must be reflected upon in conjunction with allograft transplantation. Age-based organ allocation policies could facilitate left ventricular assist devices as a bridge to nowhere for some geriatric patients. Specifically, the extended use of a left ventricular assist device by older patients could, in theory, put them in a position of not being able to get an allograft due to the fact that they have aged while on the waiting list. Unless these devices are approved as destination therapy, or age-based organ allocation policies contain exception clauses, an older person's cardiac dilemma could be confounded as an assist device recipient. Without these measures one might argue the devices themselves should be subject to age-based allocation procedures. Is this the slippery slope of ageism?

Age Factors↗
PubMed1996

ABIOMED BVS 5000: experience and potential advantages.

BACKGROUND: The ABIOMED BVS 5000 is a two-chambered extracorporeal pulsatile assist device intended for temporary circulatory support. The Food and Drug Administration granted approval for the device for postcardiotomy patients in 1992. METHODS: A worldwide registry is maintained with the BVS 5000. Currently 500 patients have been entered into the registry. The majority of patients were postcardiotomy (53%) and required biventricular assist devices (65%). RESULTS: Postcardiotomy patients have had a 27% discharge rate compared with cardiomyopathy patients with a more than 40% discharge rate. Comparison at Baylor University Medical Center of the ABIOMED BVS 5000 with a nonpulsatile device demonstrated an improved wean rate (60% versus 47%, respectively) as well as discharge rate (27% versus 17%, respectively). CONCLUSIONS: A worldwide registry combined with the experience at Baylor University Medical Center demonstrates the capability of the BVS 5000 to support postcardiotomy patients. The device is safe, simple, and effective. In addition, the pulsatile nature of the circulatory support appears to offer advantages over other systems.

Cardiac Output, Low↗
PubMedDate not supplied

Long-term mechanical circulatory support system reliability recommendation: American Society for Artificial Internal Organs and Society of Thoracic Surgeons: long-term mechanical circulatory support system reliability recommendation.

Jointly developed by members of the American Society for Artificial Internal Organs and the Society of Thoracic Surgeons along with staff from the Food and Drug Administration, the National Heart, Lung and Blood Institute and other experts, this recommendation describes the reliability considerations and goals for Investigational Device Exemption and Premarket Approval submissions for long-term, mechanical circulatory support systems. The recommendation includes a definition of system failure, a discussion of an appropriate reliability model, a suggested in vitro reliability test plan, reliability considerations for animal implantation tests, in vitro and animal in vivo performance goals, the qualification of design changes during the Investigational Device Exemption clinical trial, the development of a Failure Modes Effects and Criticality Analysis, and the reliability information for surgeons and patient candidates. The document will be periodically reviewed to assess its timeliness and appropriateness within five years.

Clinical Trials as Topic↗
PubMed1993

The Hydroflex penile prosthesis: a test case for the introduction of new urological technology.

The AMS Hydroflex* penile prosthesis was introduced for commercial distribution in 1985 but 5 years later this device was no longer available on the United States market. In an attempt to understand why this device, which initially enjoyed substantial popularity, was abruptly withdrawn from the market, patients who underwent implantation at the University of Wisconsin were interviewed and a critical analysis of the Food and Drug Administration approval process of medical devices was performed. An AMS Hydroflex penile prosthesis was implanted in 17 patients (mean age 57.7 years, range 27 to 84 years). The followup period ranged from 37 to 73 months with a mean of 58 months, and 3 patients died within that time. Of the remaining patients 10 (71%) were satisfied with the device in the first months after implantation but only 6 (43%) were satisfied at the time of followup, 9 (64%) were more satisfied with sexual relationships after receiving the prosthesis and 7 (50%) found the prosthesis simple to operate. Mechanical failure was noticed by 11 patients (79%), of whom 5 (45%) underwent further surgery. Classification of medical devices started with the enactment of the Medical Device Amendment to the Federal Food, Drug and Cosmetic Act, May 28, 1976. All medical devices that were in commercial distribution at that time were classified in 3 regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device. Before May 28, 1976 no approved application was necessary for marketing medical devices, and the Food and Drug Administration has variable amounts of information about safety and effectiveness of the different devices marketed prior to that date. Since May 1976 approved applications have been mandated for new or significantly changed devices. The specific process by which the Hydroflex prosthesis, as well as other medical devices, is approved is critically reviewed.

Adult↗
PubMed1998

Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review; companion document to direct final rule--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

Device Approval↗