Telesso Technologies Initiates Head-To-Head Study Comparing Its FDA-Approved Guide Wire-Assisted Peripheral IV Catheter To Industry's Gold Standard

Main Category: Medical Devices / Diagnostics
Also Included In: Clinical Trials / Drug Trials;  Vascular
Article Date: 24 Apr 2009 - 3:00 PDT

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Telesso Technologies Limited (ASX: TEO - News), a global healthcare company, has announced that Miami Children's hospital is the first site to enroll patients in a head-to-head trial evaluating its FDA-approved guide wire-assisted peripheral IV catheter versus the industry's gold standard device for peripheral IV placement. Telesso is funding the catheter clinical trial with Vascular Pathways, Inc.

"This post-market study represents the advancement of an important innovation in medicine designed to reduce the safety risks and costs traditionally associated with peripheral IV catheter use," said Telesso's CEO Nelson Stacks. "We are encouraged by the interest and positive feedback Telesso has received to date, and we look forward to announcing additional sites shortly with data review in Q2-Q3 of this year."

The trial will enroll approximately 400 pediatric, geriatric and oncology patients at three world-class sites who will be treated with either the novel guide-wire assisted peripheral IV catheter or the current standard of care.

About the Guide Wire-Assisted Peripheral IV Catheter

A peripheral vein is the most common site for insertion of a catheter for short-term diagnostic or therapeutic use. The catheter is placed into the peripheral vein in the arm, below the elbow and is typically passed up inside the vein to a length of 2-3 inches. Telesso's uniquely-designed guide wire-assisted peripheral IV catheter device uses a first-in-class retractable nitinol guide wire system that is believed to enable easier IV access, reduce common safety risks, significantly lessen patient pain and discomfort, and provide cost savings to facilities by lowering administrative costs associated with failed IV starts. Telesso believes this catheter device is the first clinically meaningful advancement in peripheral IV access since automatic needle retraction catheters and addresses significant unmet needs in peripheral intravenous access.

About the Telesso-VPI Agreement

Telesso Technologies Limited announced in December 2008 that it entered into a strategic agreement with Vascular Pathways, Inc. (VPI), a private company based in California, to co-develop VPI's guide wire-assisted device with the funding of the clinical trial and to potentially acquire VPI.

Source:
Jeff Riley
Cytori Therapeutics

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