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At least 163 records · Page 9Linked to original sources
PubMed2004

Celsius Control system.

The Celsius Control system (Innercool Therapies, Inc.) is an intravascular cooling catheter system consisting of the Celsius Control catheter,circulating set, and the Celsius Control console. Based on clinical studies, the system has recently received Food and Drug Administration approval for use as a device to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and recovery/intensive care, and is currently being marketed in the 10.7 Fr and 14 Fr catheter sizes. It works to regulate temperature by circulating sterile saline through the Celsius Control console, which contains an integrated assembly comprising a temperature and pressure sensing block,supply and return lines, and a 20-{m} filter with connective tubing and an independent heat exchanger and pump. The system relies on digital core temperature readings from either esophageal or bladder temperature probes. After the system is turned on, approximately 150 mL of sterile saline solution is pumped through the console and is cooled to achieve the preset temperature. This cooled saline subsequently circulates from the console through the catheter in a closed-loop manner. The distal portion of the catheter incorporates a flexible distal metallic heat transfer element that is designed to allow for direct exchange of thermal energy with blood circulating around the catheter.

Catheterization↗
PubMed1989

Medical devices; intent to initiate proceedings to establish effective dates of requirement for premarket approval for 31 class III preamendments devices--FDA. Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA) is announcing its intent to initiate proceedings to establish the effective dates of the requirement for premarket approval for 31 class III preamendments devices. The devices subject to this notice were distributed commercially before May 28, 1976, or are devices that FDA has determined to be substantially equivalent to such devices. This notice of intent identifies the 31 class III preamendments devices to which FDA has assigned a high priority for the application of premarket approval requirements. FDA is taking this action under the Medical Device Amendments of 1976.

Commerce↗
PubMedDate not supplied

Use of endovascular stents for the treatment of abdominal aortic aneurysm.

The conventional open surgical repair of abdominal aortic aneurysms is a well-established and durable procedure. However, as with all other major abdominal surgical operations, there are associated morbidities. Both mortality and morbidity increase significantly with advanced patient age and associated comorbid conditions. Endovascular aortic stent-grafts offer a significantly less invasive alternative to conventional open-surgical repair. Patients previously considered unsuitable for open repair can often receive treatment for aneurysms with endovascular techniques. The US Food and Drug Administration has recently approved two endovascular stent-graft devices for use within the United States.

Aortic Aneurysm, Abdominal↗
PubMedDate not supplied

Use of automobile restraining devices for infants.

Use of crash-tested and approved restraining devices for infants was studied in relationship to parents' locus of control, knowledge scores, and demographic data. Of 66 mothers who provided complete data, 19 (29 percent) owned and made proper use of the devices. Thirty-four mothers (52 percent) owned devices but did not use them properly.

Accidents, Traffic↗
PubMed2003

Complications of arterial closure devices.

As of July 2000, there were 4 closure devices with Food and Drug Administration (FDA) approval. The devices are successfully deployed in 89% to 98% of cases, and the complication rates are comparable to those seen with manual compression. Minor access site complications are defined as bleeding not requiring transfusion or surgical repair, hematoma (<5 cm), and pain at the puncture site. Major complications include hematoma (>5 cm), bleeding at the site requiring transfusion, pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage, plug embolization, groin infection, and death.

Anticoagulants↗