FDA Device Clearances: Glucose Recorder, Ultrasound System, Magnetic Irrigated Catheter

Jill Taylor

February 05, 2008

February 5, 2007 — The US Food and Drug Administration (FDA) has granted supplemental 510(k) clearance for a recorder for continuous glucose monitoring and for an ultrasound system for assisted vascular access and has approved a premarket approval supplement for a magnetic irrigated catheter for use in mapping and ablation.

Recorder (CGMS iPro) for Continuous Glucose Monitoring

On January 22, the FDA granted supplemental 510(k) clearance for a recorder (CGMS iPro, Medtronic, Inc) for continuous glucose monitoring by physicians.

Blood glucose monitoring is important in the management of diabetes, a disease affecting an estimated 21 million Americans. When blood glucose levels are effectively controlled, patients may delay or prevent the development of complications from diabetes.

According to Medtronic, the CGMS iPro is able to uncover patterns and potential problems in diabetes management that may not be detected when monitoring with regular finger-stick meters and HbA1c tests. The device attaches to a tiny glucose sensor inserted under the skin, which measures glucose values during daily activities. The information stored on the device is downloaded at the physician's office after a 3-day recording period and can be used to generate detailed glucose reports.

Ultrasound System (VascuView Visual) for Assisted Vascular Access

On January 23, the FDA granted 510(k) clearance for an ultrasound system (VascuView Visual, Escalon Medical Corporation) for assisted vascular access, providing a safe and efficient means of obtaining access to peripheral and central veins.

Ultrasound-assisted vascular access provides the operator with real-time visualization of the target vein and surrounding tissue before and during the insertion of a needle, guidewire, or catheter. The technique has been mandated by the Agency for Healthcare Research and Quality for the insertion of central venous catheters, which have been associated with hazards such as arterial puncture, hematoma, pneumothorax, brachial plexus injury, arrhythmias, and other adverse effects.

The new device uses a probe containing ultrasound circuitry that connects through a USB-2 interface to a tablet computer. The computer offers a touchscreen user interface, and the software includes tools such as calipers for vessel size measurement and needle guide overlay.

Irrigated Catheter for Use in Mapping and Ablation

On January 4, the FDA approved a premarket approval supplement for a magnetic irrigated catheter (Biosense Webster) for use with the Stereotaxis Navigation System for mapping and ablation procedures in patients with complex arrhythmias.

Arrhythmias, or abnormal heart rhythms, are estimated to affect more than 5 million Americans. The condition is associated with a wide range of complications, which vary from feeling fatigued to stroke or death.

The magnetic irrigated catheter is a product of Biosense Webster, a Johnson & Johnson company, developed in partnership with Stereotaxis, Inc.


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