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At least 973 records · Page 54Linked to original sources

Endovascular repair of abdominal aortic aneurysms: our early experience.

Endovascular repair of abdominal aortic aneurysms (AAA) seems to hold the potential for decreased perioperative mortality and morbidity associated with the standard open repair by eliminating major surgical exposure of the aorta and prolonged aortic cross-clamping. After several years of FDA-approved clinical trials of multiple aortic-stented grafts, the FDA, in September 1999, approved two devices (the ANCURE and the AneuRx) for commercial use in the United States. We implanted the first device in the Tri-State area at the Charleston Area Medical Center (CAMC) on Feb. 6, 2000, and this study reviews our early experiences with 15 patients utilizing these two devices at CAMC.

Aged↗

Medical devices; exemptions from premarket notification; class II devices. Final rule.

The Food and Drug Administration (FDA) is publishing a final rule exempting from the premarket notification requirements the fluoroscopic compression device, a manual compression device that allows a radiologist to press on the abdomen during a fluoroscopic procedure without exposing his or her hand to the x-ray beam. The device is classified as an accessory to the image-intensified fluoroscopic x-ray system. FDA received a petition requesting an exemption for the F-Spoon device, a type of fluoroscopic manual compression device. FDA is expanding the exemption for this type of generic device to include other fluoroscopic compression devices. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗

Inhaled insulin for the treatment of diabetes mellitus.

(1) Insulin delivery via inhalation, as an alternative to administration by injection, is under development. (2) The available evidence comparing subcutaneous (sc) insulin with inhaled insulin for persons with type 1 and 2 diabetes, shows similar glycosylated hemoglobin (HgA1c) levels after three months of treatment. (3) Clinical trials suggest that insulin delivered by inhalation has a quicker onset of action relative to regular insulin. This means insulin can be taken just prior to a meal rather than the 30 minutes prior to eating required with sc injections of regular insulin. (4) No changes in pulmonary function were noted in the studies, however data is limited to use for three months. Pulmonary thrombosis has subsequently been reported in one patient out of 1000, using Exubera(R) and the Inhale Therapeutic Systems device.

Administration, Inhalation↗

IMRT (intensity modulated radiation therapy): progress in technology and reimbursement.

For a new treatment technology to become widely accepted in today's healthcare environment, the technology must not only be effective but also financially viable. Intensity modulated radiation therapy (IMRT), a technology that enables radiation oncologists to precisely target and attack cancerous tumors with higher doses of radiation using strategically positioned beams while minimizing collateral damage to healthy cells, now meets both criteria. With IMRT, radiation oncologists for the first time have obtained the ability to divide the treatment field covered by each beam angle into hundreds of segments as small as 2.5 mm by 5 mm. Using the adjustable leaves of an MLC to shape the beam and by controlling exposure times, physicians can deliver a different dose to each segment and therefore modulate dose intensity across the entire treatment field. Development of optimal IMRT plans using conventional manual treatment planning methods would take days. To be clinically practical, IMRT required the development of "inverse treatment planning" software. With this software, a radiation oncologist can prescribe the ideal radiation dose for a specific tumor as well as maximum dose limits for surrounding healthy tissue. These numbers are entered into the treatment planning program which then calculates the optimal delivery approach that will best fit the oncologist's requirements. The radiation oncologist then reviews and approves the proposed treatment plan before it is initiated. The most recent advance in IMRT technology offers a "dynamic" mode or "sliding window" technique. In this more rapid delivery method, the beam remains on while the leaves of the collimator continually re-shape and move the beam aperture over the planned treatment area. This creates a moving beam that saturates the tumor volume with the desired radiation dose while leaving the surrounding healthy tissue in a protective shadow created by the leaves of the collimator. In the dynamic mode, an IMRT treatment session generally can be initiated and completed within the traditional 15-minute appointment window for radiation oncology clinics. In addition to being comforting for the patient, this rapid treatment delivery mode satisfies a key financial issue for hospitals and clinics by giving them the ability to handle high patient loads and achieve a more rapid return on their investment in an IMRT system. New IMRT reimbursement codes have been issued under the pass-through provisions of Medicare's Outpatient Prospective Payment System (OPPS), which authorize special or increased reimbursement levels for promising new developments in healthcare technology that previous reimbursement procedures did not address. These pass-through payments are generally applicable for defined periods during a promising new technology's early stage of adoption. In the case of codes G0174 and G0178, the effective period has been left open-ended. While the CMS adoption of these new IMRT reimbursement codes certainly paves the economic road for the diffusion of this technology by flattening out some of the economic obstacles, there are still bumps to overcome. The most obvious one is the investment in hardware and software that may be required. However, the added demands on staff and the cost of training cannot be ignored. IMRT is a treatment process involving FDA-approved medical devices, offering the hope of improved treatment outcomes with fewer complications for patients and higher reimbursement rates for hospital providers. By the end of the year 2001, there will probably be more than 75 hospitals with IMRT capabilities in place.

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

The initial United States experience with the ATS mechanical cardiac valve prosthesis.

From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement (MVR) in 72 patients (18 with coronary bypass). Overall operative mortality was 1.8% (AVR = 2.8%, MVR = 0%), with only one valve-related death. In 372 patient-years of follow-up, there were an additional four patient deaths, two of which were valve related following a stroke. Valve-related complications included: thromboembolism (linearized rate = 3.8% per patient year), of which 3/11 had chronic deficits (0.8% per patient year); thrombosis (1 MVR = 0.8% per patient year); paravalvular leak (1 AVR = 0.4% per patient year); anticoagulant-related hemorrhage (1 AVR and 5 MVR = 1.6% per patient year) with no patient mortality; prosthetic valve endocarditis (1 MVR = 0.8% per patient year); and valve dysfunction (0%). Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. This study documented the ATS Medical prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease.

Adult↗

The Oxford unicompartmental knee replacement for osteoarthritis.

The Oxford unicompartmental knee replacement is a reliable treatment for medial knee compartment osteoarthritis, provided patients with the correct indications are chosen and the appropriate surgical expertise is available. The Oxford knee has been available since fall 2000 in Canada and since the early 1980's in Europe. The latest version, Phase III, has generated interest since it uses both a minimally invasive surgical technique, as well as a free-floating, fully congruent meniscal bearing. This has the potential for faster recovery of the patient, as well as improved wear characteristics.

Arthroplasty, Replacement, Knee↗

Medical devices; gastroenterology-urology devices; classification of the ingestible telemetric gastrointestinal capsule imaging system. Final rule.

The Food and Drug Administration (FDA) is classifying the ingestible telemetric gastrointestinal capsule imaging system device into class II (special controls). The special controls that will apply to this device are set forth below. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Capsules↗