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At least 199 records · Page 11Linked to original sources
PubMed1987

Cochlear implant: audiometric results with a single-channel device.

With the FDA approval of the first cochlear implant device in November 1984, the possibility of the perception of sound became a reality for the profoundly deaf individual. The cochlear implant group of Cincinnati was involved in the coinvestigator study before the approval of the device. This paper presents data from seven patients with cochlear implants and the resulting improvement in their hearing perception, as well as a discussion about which patients can benefit from the cochlear implant.

Adult↗
PubMed1997

Current and future directions of biomedical materials research.

Biomedical materials and implants are not synonymous. Materials per se are not implanted--after configuring, processing, and finishing operations, they constitute parts of implants and other devices. The U.S. Food and Drug Administration currently does not "approve" biomaterials; rather, it approves medical devices, biologicals, and drugs. There have been important advances during the past 40 years in the clinical uses of medical implants and other devices, especially in ophthalmology, cardiology, orthopaedics, surgery and dialysis. In the 21st Century, there will be increased emphasis on curing and preventing major genetic diseases. There will be many nontraditional clinical applications of biomaterials, such as viral- and nonviral-mediated delivery agents in gene therapy, synthetic biomaterials with pharmacologic effects, and biomaterials that can integrate with the biological system to form a long-term, living, renewable interface with prosthetic implants. Therefore, those working in the field of biomaterials must become familiar with new molecular biological techniques and be able to collaborate effectively with molecular biologists.

Biocompatible Materials↗
PubMedDate not supplied

Hydromorphone polymer implant. A potential alternative to methadone maintenance.

Although methadone maintenance remains the best available treatment for opioid addiction, the need for daily oral dosing limits the effectiveness of methadone as opioid substitution therapy. Limitations of methadone maintenance include the administrative costs and burdensome time commitment associated with daily clinic visits, the danger of illicit diversion and accidental overdose associated with oral dosing, the low rate of treatment retention, and inadequate treatment capacity. A new opioid delivery device awaiting approval for clinical use may overcome some of these limitations. The device, a button-size polymer containing hydromorphone, releases near constant levels of opioid when implanted subcutaneously. Because of its location and duration of effect, the polymer may eliminate the need for daily clinic visits, reduce the costs and time constraints of treatment, reduce the risk of illicit diversion, provide an incentive for compliance with initial methadone maintenance treatment, and increase treatment capacity and retention.

Administration, Oral↗
PubMed2003

Medical device regulation for manufacturers.

Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.

Canada↗
PubMed2003

Early experience with computer-mediated flexible circular stapling technique for upper gastrointestinal anastomosis.

BACKGROUND: Creating the proximal anastomosis in laparoscopic biliopancreatic diversion with duodenal switch (LBPD-DS) and Roux-en-Y gastric bypass (LRYGBP) is a critical step in ensuring the success of the procedures. The aim of this study was to assess the safety and efficiency of performing this anastomosis using a flexible, computerized, circular stapling device. METHOD: We prospectively monitored the use of a newly FDA-approved stapling device (SurgASSIST, Power Medical Intervention) for the construction of the proximal anastomosis by a variety of approaches and reviewed the charts of 10 patients. RESULTS: We successfully constructed 9 out of 10 proximal anastomoses: 2 gastro-jejunostomies and 7 duodeno-ileostomies, without any signs of leakage. In 2 patients, the stapling technique involved a transpyloric instrumental passage; both were complicated by the difficulty to pass either the flexible scope or the anvil through the narrow pyloric lumen. In 5 patients, the anvil was placed directly through a duodenotomy and no technical problems were encountered. The median time for performing the proximal anastomosis was 19 minutes (range 9-55). There were no postoperative complications in any patients. CONCLUSIONS: Stapling using the SurgASSIST was feasible and safe for performing laparoscopic anastomoses in bariatric bypass procedures. A duodenotomy for direct placement of the anvil into the postpyloric region seems to be most feasible for duodenoileostomies, while transoral passage of the anvil can be recommended for gastro-jejunostomies. In its current form, we do not recommend transoral placement of the flexible shaft of the SurgASSIST device. Further clinical trials need to be performed for comparison with existing devices.

Adult↗