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At least 649 records · Page 36Linked to original sources
PubMed2004

Controlled localized thrombolysis with the "turbo" trellis to treat acute arterial occlusions following major surgery.

PURPOSE: To present the management of acute arterial ischemia following major abdominal and orthopedic surgery using a percutaneous thrombectomy device and a low dose of thrombolytic agent. CASE REPORT: A 38-year-old woman with T-8 paraplegia from a traumatic fall developed pelvic osteomyelitis, for which a left hemipelvectomy, hysterectomy, and partial vaginal resection were performed. Twelve hours after the procedure, the patient developed an ischemic left leg. Computed tomographic angiography demonstrated an occlusion of the left external iliac and common femoral arteries. A Turbo Trellis percutaneous thrombectomy device was used to lyse the left external iliac artery thrombosis using 1 mg of tissue plasminogen activator infused between the proximal and distal occluding balloons of the device. Total dispersion time was 5 minutes. There was complete thrombus removal without any significant bleeding complications. At 6 months, the artery remains widely patent. CONCLUSIONS: Combination therapy with mechanical thrombectomy devices and low dose thrombolytic agents can be used to treat acute arterial occlusions at a single setting. The increased speed of the Turbo Trellis may allow for smaller doses of thrombolytic agents and shorter treatment times.

Adult↗
PubMed2006

Evolution and future of preclinical testing for endovascular grafts.

The preclinical testing of endovascular grafts has evolved significantly since the creation and early testing of these devices; however, there are continued limitations in using preclinical testing to predict clinical performance. Early testing was conducted in the absence of standards and guidance specific to endovascular grafts, and references available for vascular grafts and stents did not adequately account for the complexity of endovascular graft systems. Failure of early-generation devices suggested that the testing being conducted was inadequate and that there was a lack of understanding of the in vivo environment. These concerns led to several efforts to improve preclinical testing. The Food and Drug Administration (FDA) sponsored a workshop to discuss the limitations inherent in testing of endovascular grafts, and an ISO standard for endovascular grafts was developed. Publication of the standard in 2003 succeeded in standardizing testing and reporting across device manufacturers; however, several clinical failure modes, such as migration and stent fractures, continued to be unpredicted by current preclinical testing. This, coupled with knowledge gained from additional clinical experience, led the FDA to hold a second workshop to discuss the benefits and limitations of current testing and propose future testing that may better predict device performance. This workshop was successful in accurately describing past testing, determining what has been learned, identifying issues that have not been adequately addressed, proposing modifications to address these limitations, and discussing how the proposed modifications should be implemented. While significant progress has been made in endovascular graft testing, continued collaboration among industry, academia, regulators, and clinicians will provide continued improvement in the predictability of device performance.

Animals↗
PubMed2006

Regulatory issues facing the development of drug-eluting stents: a US FDA perspective.

Coronary drug-eluting stents (DES) are a breakthrough technology that has changed the standard of care for many patients undergoing percutaneous intervention for coronary artery disease. Initial trials of two DES demonstrated significant clinical benefit with respect to the need for reintervention when compared with bare metal stents. However, more recent studies of DES involve in-patients with more complex disease, such as bifurcation lesions, chronic total occlusions and multiple-vessel disease. Additionally, DES are now being evaluated in patients previously only considered for surgical intervention. Assessment of DES in these complicated patient populations can lead to challenges in trial design, but the US FDA is willing to consider alternative clinical trial designs and statistical analysis plans. Other complex issues associated with DES include duration of clinical trials to determine safety, and the appropriate dose and duration of concomitant antiplatelet therapy. Finally, the FDA acknowledges that DES are complex products to produce and we believe that through interaction with the FDA during development, difficulties with test methodologies, animal studies and clinical trial designs can be addressed. The future of DES likely involves new stent and carrier materials, including biodegradable materials and new drugs and biologicals. The FDA anticipates continued collaboration with physicians, manufacturers, academic institutions and professional societies.

Blood Vessel Prosthesis↗
PubMed2002

Assessment of the DIXTAL DX-2710 automated oscillometric device for blood pressure measurement with the validation protocols of the British Hypertension Society (BHS) and the Association for the Advancement of Medical Instrumentation (AAMI).

OBJECTIVE: To assess the Dixtal DX2710 automated oscillometric device used for blood pressure measurement according to the protocols of the BHS and the AAMI. METHODS: Three blood pressure measurements were taken in 94 patients (53 females 15 to 80 years). The measurements were taken randomly by 2 observers trained to measure blood pressure with a mercury column device connected with an automated device. The device was classified according to the protocols of the BHS and AAMI. RESULT: The mean of blood pressure levels obtained by the observers was 148+/-38/93+/-25 mmHg and that obtained with the device was 148+/-37/89+/-26 mmHg. Considering the differences between the measurements obtained by the observer and those obtained with the automated device according to the criteria of the BHS, the following classification was adopted: "A" for systolic pressure (69% of the differences < 5; 90% < 10; and 97% < 15 mmHg); and "B" for diastolic pressure (63% of the differences < 5; 83% < 10; and 93% < 15 mmHg). The mean and standard deviation of the differences were 0+/-6.27 mmHg for systolic pressure and 3.82+/-6.21 mmHg for diastolic pressure. CONCLUSION: The Dixtal DX2710 device was approved according to the international recommendations.

Adolescent↗
PubMed2004

New Product Review (September 2003). Norelgestromin/ethinyl oestradiol transdermal contraceptive system (Evra).

This new transdermal contraceptive system (contraceptive patch), Evra (Janssen-Cilag), received a UK product licence in 2003. In clinical trials: Consistent doses of norelgestromin and ethinyl oestradiol are released into the systemic circulation daily. Pharmacokinetic data suggest that levels are sufficient to inhibit ovulation for at least 7 days. The overall Pearl index for the contraceptive patch (1.24; 95% CI 0.19-2.33) was similar to that of a triphasic combined oral contraceptive (COC) pill (2.18; 95% CI 0.57-3.8). Self-reported "perfect" compliance was significantly better with the contraceptive patch (88.2%) than with a combined contraceptive pill (77.7%). Patch detachment, requiring replacement with a new patch, with normal daily activity is uncommon (4.6%). Breakthrough bleeding and spotting were significantly more common with the contraceptive patch than with combined oral contraception in the first two cycles but differences were not significant by cycle three. In general, reported side effects were not significantly different with contraceptive patch or combined pill use. However, breast tenderness in the first two treatment cycles was more common with patch use. Symptoms were mild to moderate in 85% of women and were rarely treatment limiting. Currently, there are limited data regarding risk of venous thromboembolism, and cervical or breast cancer with the contraceptive patch. No clinically significant alterations in metabolic or haemostatic parameters were identified with contraceptive patch use. A month's supply of the contraceptive patch costs 7.74 UK pounds. Combined oral contraception prices range from approximately 0.80 to 5.00 UK pounds and hormone replacement therapy patches range from 10.00 to 13.00 UK pounds. The contraceptive patch offers additional choice for women who wish to use a combined hormonal method of contraception.

Administration, Cutaneous↗
PubMed1997

Regulatory issues unique to clinical trials on periodontal diagnostic methods and devices.

A wide variety of in vitro diagnostic products have been proposed for use in patients with periodontal disease. The Food and Drug Administration (FDA) review focuses on three important issues. First, the product must exhibit acceptable analytical performance (accuracy, precision, analytical sensitivity, and analytical specificity). Second, the effectiveness of the device must be clearly defined. The studies required to establish this will depend largely on the proposed intended use of the product. At a minimum, clinical or diagnostic sensitivity and specificity should be established. Finally, the product must meet the labeling requirements for in vitro devices. These requirements outlined in CFR 809.10(b) are comprehensive and cover 15 key elements including information about the principles of the analytical method; handling of instruments, reagents, and patient samples; test limitations; and test performance. Applicants developing products for any in vitro diagnostic device are encouraged to review the labeling regulations along with other divisional and office guidance material to help in defining the submission requirements. The FDA is willing to meet and work with companies prior to and during preclinical and clinical trials to assist in the development of appropriate study protocols.

Clinical Trials as Topic↗
PubMed1997

Voluntary programs: ADA Seal program and international implications.

For about 130 years the American Dental Association (ADA) has aided the profession and the public in selecting safe and effective dental products. Since 1930, dental products have been evaluated through the ADA Seal program. In accordance with the ADA's Bylaws, the Council on Scientific Affairs assesses information evaluating the safety, efficacy, appropriate use, and promotional claims of dental products. In doing so, the Council may award the ADA's Seal of Acceptance. In collaboration with interested parties, expert consultants, and Council members, the ADA produces guidelines suggesting appropriate methodologies and submission data to assist manufacturers in voluntarily earning the Seal of Acceptance. To date, numerous professional and consumer products have been evaluated, and about 1,300 of these products bear the Association's Seal of Acceptance. When a product is awarded the Seal it means that adequate data have been submitted and reviewed and, based on available information, the product meets ADA guidelines of safety and effectiveness. Dental health care professionals and consumers who use products that have the Seal can be confident that a product's properties and performance are consistent with current professional standards and manufacturers' claims. The ADA Seal program serves to help dentists and manufacturers meet their ethical obligations to the public by promoting safe and effective health care products.

American Dental Association↗
PubMed2005

FDA report.

Explore the source record for details and available documents.

Device Approval↗
PubMed2005

FDA report.

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Dental Equipment↗
PubMed2006

FDA report.

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Bone Plates↗
PubMed2006

Osteogenic protein-1 : a review of its utility in spinal applications.

The potentially revolutionary effect that bone morphogenic proteins (BMPs) could have on orthopaedic surgery has fueled an exhaustive research effort that continues today. Upwards of 1.5 million bone-grafting operations take place in the US annually, with the anterior and posterior iliac crest being the most common donor site for autologous bone graft. Harvesting autologous bone graft, however, is not benign. It is postulated that a synthetic bone graft containing BMPs would possess the characteristics of autologous bone that allow new bone formation: osteogenesis, osteoinduction, and osteoconduction, without the negative repercussions related to bone harvesting. As a result of the ensuing research following their discovery some 40 years ago by Marshall Urist, the basic science behind BMPs has been largely uncovered. New information on BMPs now comes from clinical trials regarding their utility and efficacy in surgical applications. To date, BMPs have been studied in skeletal bone surgery throughout the body, and have been found to be particularly useful in surgical applications such as spinal arthrodesis. Osteogenic protein-1 (OP-1), or recombinant human BMP-7, is one subtype of BMPs that has shown particular potential in clinical trials. Pre-clinical and clinical studies have, thus far, garnered OP-1 a Humanitarian Device Exemption approval for spinal applications in the US. As clinical trials with larger patient numbers and longer clinical follow-up are completed, the usefulness of OP-1 as a bone graft substitute will be better elucidated.

Animals↗
PubMed1995

The evolution of FDA policy on silicone breast implants: a case study of politics, bureaucracy, and business in the process of decision-making.

The central issue facing federal regulation of breast implants is that while such devices are not functionally necessary or needed for survival, the side effects may be harmful and have not been proven unharmful. The Medical Device Amendments of 1976 appear to require such evidence prior to the FDA permitting the unrestricted marketing of these devices. However, only recently have such requirements been imposed by the FDA. The author examines the FDA's decision-making process, particularly as applied to silicone breast implants, and the factors that appears to have affected such decisions. In pursuing this study, the activities of a number of interest-group actors, as well as congressional responses and the role of federal bureaucratic actors, were examined. In 1992, the FDA established a regulatory protocol that effectively withdrew most silicone breast implants from the market for the purpose of breast augmentation and allows for the monitoring of the impact of new implants on women's health. This increase concern for determining the safety of breast implants is due to a number of factors, which are examined in this article.

Breast Implants↗