SafeBreak® Vascular Cleared for Pediatrics

FAYETTEVILLE, Ark. - Amzeal -- Lineus Medical, a medical device company focused on reducing IV complications, announced that the company's flagship product, SafeBreak Vascular, has received clearance from the U.S. Food and Drug Administration (FDA) for use in pediatric patients. SafeBreak Vascular has been shown in adult clinical studies to reduce IV complications with its innovative breakaway technology¹.

SafeBreak Vascular is the first breakaway device cleared by the FDA and proven to reduce IV complications in adults by 44%¹. It fits between the IV tubing from the IV pump and the patient's IV access point at the arm. When there is a damaging force on the line, SafeBreak separates to protect the patient's IV. This innovative feature helps prevent accidental dislodgement of the catheter, as well as other IV complications caused by damaging forces on the IV line¹. This is especially important for pediatric patients who may be more active, less inclined to follow instructions, and less aware of their surroundings.

"We are incredibly proud to receive clearance from the FDA for the use of SafeBreak Vascular with pediatric patients," said Vance Clement, CEO of Lineus Medical. "SafeBreak provides a simple, effective solution for preventing IV complications, which reduces IV restarts and additional needlesticks for patients.  Now, it doesn't matter if the patient is 1 or 100 years old, SafeBreak is cleared for use on all peripheral IVs.  Our goal is to have a SafeBreak on every IV line, everywhere in the world, and this additional clearance lets us help one of the most vulnerable populations that needs it the most, our kids."

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ABOUT LINEUS MEDICAL

Lineus Medical is the developer of a unique, patented, break-away technology that is designed to work with all types of medical tubing. Complications with feeding tubes, IV lines, urinary catheters and any other type of medical tubing may be reduced as breakaway devices separate to protect the patient. More information about Lineus Medical can be found on the company website:  www.lineusmed.com or you can follow the company on Twitter or LinkedIn.

¹ Dipper Study Data on File

MKG-0194 REV 00