Flowonix Medical Patient Therapy Controller receives FDA approval


Flowonix Medical’s newest product, the Patient Therapy Controller (PTC), has been approved for US market release by the Food and Drug Administration. The PTC interfaces with the company’s Prometra platform of intrathecal infusion devices. A small, hand-held device with a touch-screen, the PTC allows the patient to initiate a bolus delivery of medication from the implanted pump.

“The new Patient Therapy Controller, or PTC, allows patients to administer a bolus of medication as needed,” stated Jason Pope, president of Summit Pain Alliance in Petaluma, USA. “Patients need only to press the Rx button and hold the PTC over the implanted pump. The PTC then communicates with the pump and the supplemental medication is delivered. It is intuitively easy to use and it provides greater flexibility for pump patients.”

Chronic pain is estimated to affect 116 million Americans. Back pain alone is the leading cause of disability in Americans under 45 years old. Flowonix is dedicated to providing ongoing solutions designed for the relief of pain, receiving approval for three new products in 2015, including the Prometra II, the longest-lasting targeted drug delivery device available.

“Breakthrough pain can be a significant problem for this patient population. Oral medications are not ideal for treating breakthrough pain because of the potential for side effects and abuse,” stated W Porter McRoberts, medical director of Interventional Spine, Pain and Neurosurgery at Holy Cross Hospital in Fort Lauderdale, USA. “The PTC allows a patient experiencing breakthrough pain to deliver a bolus of pain medication which provides quick and effective pain relief. Not only can the PTC help to control breakthrough pain better, it may help reduce or eliminate the need for oral analgesics.”

Flowonix president and chief executive officer, Steven Adler added, “Our new Patient Therapy Controller demonstrates our ongoing commitment to making the Prometra drug delivery system the most advanced infusion system available. This device will allow a great number of patients, specifically those with variable pain pathologies, to benefit from targeted drug delivery.”