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At least 217 records · Page 12Linked to original sources
PubMed1999

[Endovascular stent graft].

Endovascular stent grafting for aortic aneurysms using metallic stents covered with conventional vascular grafts has attracted attention as a catheter-based, minimally invasive alternative to open surgery. Since the first clinical experience with endovascular stent grafting for an abdominal aortic aneurysm was reported in 1991, experimental and clinical investigations have between undertaken world wide. Although several commercial bifurcated stent grafts for abdominal aortic aneurysms are currently available in Europe and Australia, none of the devices are approved for clinical use in Japan and the USA. Hand-made devices are still used in each institution particularly for thoracic aortic aneurysms. Endovascular stent grafting is feasible for aneurysm repair within limited conditions. However, several unsolved issues remain concerning not only delivery devices which require precise skill in stent-graft deployment, but also concerning patient selection and proper indications. Further investigation is necessary to clarify graft durability, aneurysmal neck enlargement, and the fate of the excluded aneurysm sac for long follow-up periods.

Aortic Aneurysm↗
PubMed2000

HeartSaver VAD: a totally implantable ventricular assist device. Results of in vivo studies.

Currently, the most widely utilized ventricular assist devices (VADs) require percutaneous connections and are located either externally (e.g., Thoratec, Abiomed) or intra-abdominally (e.g., Novacor, TCI). These attributes have been implicated in a variety of complications (infection, thromboembolic, gastrointestinal, etc.). To address these concerns, a totally implantable VAD that requires no percutaneous connections and can be implanted in the left hemi-thorax has been developed. The developed device has undergone in vivo evaluation as part of the design and development process. A total of 43 implants in the bovine model, with 5 device versions, have been conducted between July 1992 and February 2000. These studies successfully have demonstrated several important aspects of the developed device, including 1) feasibility of a totally implantable system; 2) capability of the device to support a dysfunctional heart; and 3) ability of the device to provide flows up to 10 L/min in a physiological setting. The studies to date have played a vital role in the design and development process as well as demonstrating the feasibility of a totally implantable intrathoracic VAD. Based on these studies, design optimization was conducted, resulting in the development of the pre-clinical version of the device in preparation for clinical trials.

Animals↗
PubMed2003

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

Bone Cements↗
PubMed1995

Holmium:YAG surgical lasers.

"Holmium:YAG (Ho:YAG)" is the shorthand name for a family of solid-state lasers that use the doping element holmium in a laser crystal (e.g., YAG [yttrium-aluminum-garnet]) and that emit energy at approximately 2.1 microns. This wavelength is relatively new to medicine and has been used in laser surgery for only about the last six years. Like the carbon dioxide (CO2) laser when it was first used clinically, the Ho:YAG laser is poised for rapid and wide-spread use. Ho:YAG lasers, like CO2 lasers, offer precise cutting with minimal damage to adjacent tissue; however, unlike CO2 lasers, they also offer fiberoptic delivery (which is ideal for endoscopic use) and the ability to treat tissue in a liquid-filled environment (e.g., saline, blood). The initial specialty for which the Ho:YAG laser was used was arthroscopic surgery, especially diskectomy. Today, it is effectively used in many surgical specialties, including general surgery, urology, laparoscopy, neurosurgery, lithotripsy, angioplasty, orthopedic surgery (which includes procedures such as meniscectomy, bone sculpting [may also be performed in plastic surgery], and some experimental surgery, such as cartilage shrinking to tighten loose joints), and dentistry. Because of its broad range of potential applications, it has been called the "Swiss Army Knife" of lasers. High-powered Ho:YAG lasers, which enable surgeons to work more quickly and cut more smoothly, have been made available only within the last three years (units offering > 20 W) to 18 months (units offering > 60 W). Because of this rapid increase, high-powered units are still relatively expensive, and it is not yet clear whether maximum power outputs will continue to increase or whether the cost of higher-power units will begin to come down. Although low-power and high-power Ho:YAG lasers can be used for the same procedures, their different ranges of possible clinical techniques make them better suited to different applications: low-power units are preferable for small-joint and some head-and-neck surgeries or for office use, and high-power units are more suitable for use in major surgery, such as gastrointestinal surgery or surgery in large joints. This evaluation includes two units at both ends of the Ho:YAG power spectrum--one 10 W and one 60 W--and thus provides a guide to evaluating other Ho:YAG lasers that are currently available or that will be entering the market.(ABSTRACT TRUNCATED AT 400 WORDS)

Carbon Dioxide↗
PubMed2006

Off-label use: an industry perspective on expanding use beyond approved indications.

The use of a medical device outside of its approved label is commonly referred to as "off-label use." Off-label use arises when physicians see the opportunity to leverage an approved therapy for an unmet patient need. This practice typically occurs on a case by case basis without clear documentation of indication, frequency, or outcomes. Sponsors have a responsibility to consider formal indication expansion depending on the actual use, how well the therapy fits the unmet need, product iteration cycles, adoption speed, resource demands, and the clinical risk to benefit ratio. This responsibility is particularly relevant for breakthrough technologies where adoption patterns can span a variety of uses. For Boston Scientific's drug-eluting stent program, a surveillance program was developed in collaboration with the FDA to compile information on practice patterns and safety outcomes for the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System. The ARRIVE program has used a Web-based format to collect real-time data on TAXUS stent use. This >7,000 patient registry documents both on-label and off-label use and key safety measures for the TAXUS stent. This real-world registry has successfully provided a data-driven approach to BSC's product development strategy, including the initiation of formal label expansion programs. For complex or combination products, more innovative ways of capturing risk to benefit data are needed to define off-label use and to maximize the potential therapeutic utility as supported by safety data.

Blood Vessel Prosthesis Implantation↗
PubMed2005

Bayesian predictions of final outcomes: regulatory approval of a spinal implant.

We describe a randomized controlled trial of an investigational spinal implant. The investigational device has an obvious benefit in comparison with control in that it precludes the need for harvesting bone graft and the pain and morbidity associated with it. Therefore, the principal comparison is one of noninferiority. The primary endpoint is overall success at two years. The "noninferiority margin" is 10%. Waiting for two years after the last patient's surgery may not be necessary depending on earlier measurements of success. We model the relationship between one- and two-year results. Our Bayesian analysis considers all available information, including some patients who have both one- and two-year results and some patients who have only one-year results. Our study provides an example in which Bayesian predictive modeling provided earlier information than otherwise and therefore it shortened the time line of the development of a therapeutic strategy.

Bayes Theorem↗
PubMed2004

[Mandibular advancement devices in the treatment of obstructive sleep apnea].

UNLABELLED: Obstructive sleep apnea (OSA) affects approximately 450,000 people in Poland. Use of nasal continuous positive airway pressure (nCPAP) devices and laryngeal surgery are widely accepted OSA treatment methods. In 1995 ASDA approved oral devices for treatment of OSA patients. The aim of the study was to determine efficiency of mandibular advancement devices (MAD) in OSA therapy. MATERIAL AND METHODS: The study group included 20 patients with OSA, all of whom did not tolerate nCPAP and did not have indications or did not agree for surgical treatment. RESULTS: Control polysomnography was carried out in 11 patients using MAD. In 64% of patients AHI was lower then 10. No correlation between MAD use and AHI values was found. 45% of patients declared improvement of sleep quality and life comfort. CONCLUSIONS: Use of mandibular advancement devices is an important alternative therapy of OSA.

Adult↗
PubMed2003

Good news and bad news: the cost of mending a broken heart.

The approval of a new treatment protocol known as "destination therapy" highlights the realities of today's health economics. This article discusses the technology, the economics and the philosophy of the newly approved left-ventricular-assist systems.

Cost-Benefit Analysis↗