Flowonix Medical said today it won FDA 510(k) clearance for its Patient Therapy Controller designed to interface with intrathecal infusion devices.
The PTC is a small hand-held device with a touch screen that allows patients to initiate bolus delivery of medication from implanted pumps, according to the Mount Olive, N.J.-based company. The device is designed to operate with the company’s Prometra platform of infusion devices.
“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. 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,” Dr. W. McRoberts of Fr. Lauderdale, Florida’s Holy Cross Hospital said in prepared remarks.
The Prometra device is designed to support pain-relief medication delivery, the company said. Flowonix said it received approval for 3 new products this year including its Prometra II delivery device.
“The new Patient Therapy Controller or PTC allows patients to administer a bolus of medication as needed. 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,” Summit Paint Alliance prez Dr. Jason Pope said in a press release.
“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,” Flowonix CEO Steven Adler said in a prepared statement.
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