15 August, 2016

FDA Clears SPR Therapeutics Pain Management Device

SPR Therapeutics received clearance from the United States Food and Drug Administration to commercialize the SPRINT™ Peripheral Nerve Stimulation (PNS) System. SPRINT is the first and only completely reversible and minimallyinvasive peripheral nerve stimulation system cleared to provide relief of chronic and acute pain, including postoperative and posttraumatic pain.




"The FDA's clearance comes at a critical time when physicians, patients and the U.S. healthcare system are seeking therapies to manage pain while reducing opioid use," said Maria Bennett, SPR Therapeutics Founder, President and CEO. "SPR has developed a drugfree treatment for relieving chronic and acute pain. With more than 100 million Americans suffering from chronic pain, and more than two million people suffering severe acute and postoperative pain every year, we believe SPRINT will be a game changer in the world of pain management."

The SPRINT PNS System includes a threadlike, coiled wire, or lead, and a matchboxsized wearable stimulator, about the weight of four quarters. The lead is placed percutaneously, or through the skin, via a fine needle and connects externally to the wearable stimulator. The stimulator delivers electrical stimulation through the lead, which activates peripheral nerves to achieve pain relief.

SPRINT is unique in that it allows lead placement as far as two to three centimeters from the targeted nerve. This simplifies the lead placement procedure for physicians and gives them the distinct ability to preferentially stimulate specific fibers of the nerve to maximize pain relief. This innovative approach to PNS is fully reversible, as the device is designed to be withdrawn without surgery at the end of the 30day treatment period.

A press release can be found from SPR Therapeutics website.

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