Tuesday, February 25, 2020

Tuesday, February 25, 2020

FLOWONIX MEDICAL: Receives FDA Approval for its Prometra II® 40 mL Programmable Pump System


Flowonix Medical, Inc. issued the following announcement on Oct. 24.

Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software. This system approval expands the reservoir size options to include both 20 mL and 40 mL pumps, and also includes the claim of a 10-year battery life at average flow rates, potentially reducing the amount of replacement surgeries for patients. The Prometra II 40 mL Programmable Pump is designed to operate identically to the previously approved 20 mL pump, which has shown clinical benefits for many of the 7,000 patients implanted worldwide

The first implant of the Prometra II 40 mL pump was performed on Monday, October 21st in Scottsdale, Arizona by Interventional Pain Physician Lisa Stearns M.D., a world leader in the treatment of Cancer pain. Dr. Stearns, a pioneer in the field, has performed extensive clinical research in the use intrathecal drug delivery versus the use of oral opioids and is a co-founder of the Cancer Pain Research Consortium. Following her first use of the 40 mL Prometra II pump, Dr. Stearns noted, "With the addition of a 40 mL pump to the product line, physicians and patients can now choose the appropriate pump best suited to their own clinical needs. The larger reservoir, programming options, and battery life will improve patient outcomes and ultimately reduce healthcare utilization long-term. All patients deemed appropriate for intrathecal therapy, whether suffering from chronic non-malignant or cancer related pain will benefit from this therapy. "

Flowonix Product Manager Nicolette Pappas outlined the impact of the new reservoir size on the patient experience, "Patients can now enjoy the benefits of Prometra Technology, including novel infusion modes, consistently accurate dosing, and the potential for reduced dosage requirements, all while reducing the frequency of refill appointments. This is especially meaningful to those patients that have difficulty getting to their doctor's office for transportation or mobility reasons."

"The launch of the Prometra II 40 mL Programmable Pump is an important step for Flowonix", said Larry Heaton, President & CEO of Flowonix Medical, Inc. "This allows us to promote the substantial benefits of the Prometra system for patients who are best served by 40 mL pumps, in particular, patients who suffer from Cancer pain. We are excited to enter this underserved clinical market for many reasons, including the opportunity for Flowonix to grow market share, the dramatic cost savings targeted drug delivery can provide versus oral opioids, and most importantly, the clinical benefits to Cancer pain patients including better pain management, reduced side effects and improved cognition."

The new 40 mL Programmable Pump includes an update to the recently approved Maestro Programmer, building on the existing easy-to-use platform and improving the overall customer experience.

About the Prometra® II Programmable Infusion System

The Prometra Programmable Infusion System is FDA approved for intrathecal infusion of Infumorph® (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).

About Flowonix

Flowonix Medical Inc. (www.flowonix.com), headquartered in Mt. Olive, New Jersey, is working with healthcare professionals to help ease suffering associated with chronic pain and enabling patients to improve their lives through innovation and therapy advancements. Our goal is to become the leading implantable drug delivery company in the world.  Founded in 2005, Flowonix is working closely with physicians to enhance the capabilities of implantable drug delivery systems.  For more information, please visit http://www.flowonix.com.

About The Center for Pain and Supportive Care (CPSC)

Dr. Stearns' Center for Pain and Supportive Care (CPSC) is nationally and locally recognized as a center for excellence in both cancer and chronic pain management. CPSC's clinical experience indicates that successful pain treatment achieved by focusing on the whole person, improving not only pain relief but also quality of life. Aside from managing pain by traditional measures, Center for Pain and Supportive Care offers a full line of interventional pain management procedures, yoga therapy, fitness and yoga classes, group medical visits and unparalleled experience in implantable pump and electronic stimulation devices. For more information, please visit http://www.azcpsc.com.

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