Flowonix Medical Inc. Announces First Implants of Prometra® II
First U.S. implants of state-of-the-art intrathecal infusion device
MOUNT OLIVE, N.J., May 6, 2015 /PRNewswire/ -- Flowonix Medical, Inc., announced today that the first implants of its Prometra® II intrathecal infusion pump took place on May 5, 2015 at St. Francis Hospital in Charleston, West Virginia. A Prometra II pump was implanted in three patients: a 56-year-old man, a 68-year-old woman, and a 53-year-old man for chronic conditions, including neck pain and lower back pain. The procedures were all performed by Dr. Timothy Deer and Dr. Christopher Kim. The patients were reported to be doing well, and Drs. Deer and Kim considered the surgeries successful.
"These first implants of the Prometra® II infusion system were successful, without any complications," stated Dr. Deer. "The Prometra devices from Flowonix are very accurate intrathecal infusion systems, which are critical to improved patient safety, and Prometra II offers a proprietary flow-activated safety valve or FAV™ technology, designed to shut off drug flow to the patient if a high flow rate should ever occur during magnetic resonance imaging. Prometra II gives our patients added safety, in case an MRI is ever needed."
Magnetic resonance imaging (MRI) is an imaging procedure that may be contraindicated for patients with certain implanted devices because strong electromagnetic energy may interfere with device function.
"The patients are doing well and will get improved pain relief," added Dr. Kim. "It is a major advantage of the Prometra II system that it has such a long service life. This not only benefits our patients, but also the healthcare system. A recent retrospective study from the Cleveland Clinic found this type of drug-delivery system to be cost effective,1 even when looking at older and less efficient devices. With the state-of-the-art Prometra II pump, our patients can expect many years of accurate drug delivery at costs that are likely much lower than other forms of pain therapy."
The study by Bolash and colleagues found the median device longevity of these older infusion systems to be 5.4 years with a median cost per day of $10.46. The newer Prometra devices have a ten-year service life, which is nearly double that of older systems.
"Prometra II borrows from the outstanding technology of its predecessor, Prometra," added Steve Adler, President and CEO of Flowonix. "Like its predecessor, Prometra II is a long-lasting device with the most accurate drug delivery available today in any implantable intrathecal infusion system, but it also offers FAV™ technology for enhanced patient safety. These first implants of Prometra II in the United States mark another major milestone for Flowonix. All of us at Flowonix extend our congratulations to Drs. Deer and Kim on the successful implants of Prometra II and we wish the very best to their patients."
About Flowonix
Flowonix Medical Inc. (www.flowonix.com), headquartered in Mt. Olive, NJ, is dedicated to working with healthcare professionals to help ease suffering associated with chronic pain and allow patients to reclaim their lives through innovation and therapy advancements. The strategic business goal of Flowonix Medical Inc. is to become the leading implantable drug delivery company in the world. Founded in 2005, Flowonix Medical Inc. received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. The company received approval by the FDA to market the Prometra in 2012. Flowonix Medical Inc. has been granted multiple patents, and is focused on working closely with physicians to rapidly improve the capabilities of implantable drug delivery and management systems.
For more information, please visit http://www.flowonix.com.
1 Bolash R, Udeh B, Saweris Y et. al. Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: a retrospective analysis of 365 patients. Neuromodulation 2015; 18:150-156. Median device longevity for all pumps was 5.4 years (97.5% confidence interval, range 5.0 to 5.8).
SOURCE Flowonix Medical, Inc.
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