PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

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

At least 235 records · Page 13Linked to original sources
PubMed1997

Post-decision diagnosis: medical device preemption alive and mostly well after Medtronic, Inc. v. Lohr.

In Medtronic, Inc. v. Lohr, the United States Supreme Court, in a five-to-four split, held that the Medical Device Amendments of 1976 did not preempt state tort claims against a pacemaker manufacturer. A careful reading of the factually specific holding of this case suggests that manufacturers of medical devices distributed pursuant to premarket approval requirements and investigational device exemption can still successfully raise preemption as a defense to state common law tort claims.

Device Approval↗
PubMedDate not supplied

Clinically available intracorporeal left ventricular assist devices.

There are now 3 commercially approved intracorporeal left ventricular assist devices (LVADs). Product similarities include (1) LV apex, to pump, to ascending aorta flow patterns, (2) excellent hemodynamic support with reversal of heart failure and neurohormone/cytokine milieu, and (3) the requirement of major surgery for device implantation and later explantation, with or without transplant. Two electrically powered models allow a tether-free existence and hospital discharge. All complications are being addressed, and in the past decade, device failure and thromboemboli have been reduced. Infection continues to be an obstacle to more widespread adoption of therapy. Despite pre-LVAD shock, most patients (65% to 78% by Food and Drug Administration data) survive until transplant (averaging 80 to 96 days of LVAD support), and posttransplant survival is equal to nonbridged patients. As the problem of infection is reduced, more widespread LVAD use can be anticipated.

Device Approval↗
PubMed1999

The Hemopump in 1997: a clinical, political, and marketing evolution.

BACKGROUND: The Hemopump (Medtronic, Inc, Minneapolis, MN) was conceived in 1975 and designed in 1982 as a temporary, extracorporeal cardiac assist system. Although it has been used clinically in Europe, it is not currently available in the United States. METHODS: In vitro and in vivo testing of the Hemopump began in 1983. Clinical investigations have included studies of patients in cardiogenic shock, Hemopump-supported coronary artery bypass operations in Sweden, and European studies of percutaneous transluminal coronary angioplasty (PTCA) with Hemopump support. RESULTS: The Hemopump has demonstrated positive hemodynamic effects in patients. Laboratory and clinical studies have shown that the nonpulsatile axial flow generates flows of up to 4.5 L/min while maintaining adequate perfusion of other organs. In Europe, hemopumps have been used successfully to support coronary bypass and PTCA. CONCLUSIONS: The Hemopump system is simple, inexpensive, and well tolerated by the blood elements. Moreover, its design allows flexibility in supporting patients during cardiopulmonary bypass (in lieu of conventional techniques) and high risk angioplasty, as well as in rescuing patients with low cardiac output.

Angioplasty, Balloon, Coronary↗
PubMed2003

[Stent grafting for aortic aneurysms].

Endovascular stent grafting for aortic aneurysms/dissections using metallic stents covered with conventional vascular grafts has attracted attention as a minimally invasive alternative to open surgery. Since the first clinical experience of endovascular stent grafting for abdominal aortic aneurysm was reported in 1991, numerous clinical applications have been undertaken worldwide. Although several commercial bifurcated stent grafts for abdominal aortic aneurysm are available in various countries, including Europe, the USA, and Australia at present, none of the devices are approved for clinical use in Japan. Particularly for thoracic aortic aneurysms, hand-made devices are still used in individual institutions. Endovascular stent grafting is feasible for aneurysm repair within limited conditions. Although further investigation is necessary to clarify the indications, it is clear that aortic aneurysms could be successfully treated with precise stent-graft deployment and proper patient selection based on our 10-year follow-up results.

Aortic Dissection↗
PubMed2000

The ventricular assist device: An overview.

With the continued shortage of available donor organs, the need for a mechanical alternative to support increasing numbers of heart failure patients has become increasingly apparent. This article reviews the ventricular assist devices currently approved by the Food and Drug Administration, and some of the concepts surrounding ventricular assist device therapy. Common postoperative and long-term concerns are addressed, and nursing care of these complicated patients is reviewed.

Equipment Design↗
PubMed1997

Drug patent expirations and the speed of generic entry.

OBJECTIVE: Using recent data, to analyze the generic drug entry phenomenon to determine the factors that influence the speed and likelihood of generic drug entries. DATA SOURCES: Data for 81 drugs that have lost patent between 1987 and 1994. Patent and exclusive marketing rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates: FDA Drug and Device Product Approvals (Jan. 1987-Dec. 1994). Numbers of pending generic applications: FDA Office of Generic Drugs Quantitative Report-ANDAs and AADAs (Nov. 1990-Jan. 1993). Sales revenue: Pharmaceutical Data Services, Walsh-America. STUDY DESIGN: This study appropriately recognizes generic entry as a survival problem, and uses a proportional hazard method for analysis. PRINCIPAL FINDINGS: (1) There is a negative relationship between an innovative drug's sales revenue and the time to generic entry. (2) Entries of generics tend to be slower for drugs that have either very few or a very large number of competing brands in the marketplace. (3) The time to generic entry increased overall between 1987 and 1994. (4) Drugs that primarily treat chronic symptoms tend to enter faster than the types of drugs that primarily treat acute illnesses. CONCLUSIONS: The analysis shows that the generic industry is targeting large-revenue products and chronic drug markets. Entry of a generic drug is influenced by the existing branded substitutes in the marketplace. Surprisingly, the generic drug entry process has slowed despite many changes that would facilitate entry.

Drug Industry↗