dilluns, 11 d’abril del 2016

St. Jude Medical’s Axium chronic pain device makes its U.S. debut

St. Jude Medical's AxiumSt. Jude Medical (NYSE:STJ) today announced the U.S. debut of its Axium neurostimulator system, after the device won FDA approval in February for treating chronic pain.

The 1st patients were implanted in West Virginia and California with the Axium device, which uses dorsal root ganglion stimulation to treat moderate to severe chronic intractable pain of the lower limbs in adult patients with complex regional pain syndrome, St. Jude said. The Axium is slated to be implanted in 25 states in the coming weeks, with 100 procedures due in the 1st month after launch, the Little Canada, Minn.-based company said.

“Since the approval of dorsal root ganglion stimulation with the Axium system in February 2016, we have focused on a strategic rollout with a disciplined training program for physicians across the country. We believe this approach ensures patient access to this highly effective new therapy to help manage their chronic pain,” vice president Dr. Allen Burton said in prepared remarks. “The 1st Axium system implants in the United States reflect our ongoing commitment to working with our physician partners to deliver on our promise to transform the treatment of chronic pain.”

St. Jude said it aims to train more than 300 surgeons on implanting the Axium device this year.

“Although many chronic pain patients can find relief from a traditional spinal cord stimulation device, many patients suffering from focal chronic pain including CRPS I and II don’t receive adequate pain relief from spinal cord stimulation,” said Dr. Timothy Deer, of Charleson, W.Va.’s Center for Pain Relief, 1 of the 1st to implant Axium. “Adding dorsal root ganglion stimulation with the Axium neurostimulator system to my therapeutic arsenal is an exciting step in the treatment of chronic intractable pain of the groin, knee and foot. I’m impressed with the speed in which I am able to reach and stimulate the dorsal root ganglion, something I was unable to do before the Axium neurostimulator system. For the 1st time, I now have a device designed specifically for the large and growing number of under-treated chronic pain patients I could not previously serve.”

“Stimulation of the dorsal root ganglion is the 1st therapy option designed specifically for patients suffering from complex regional pain syndromes. This serious and traditionally challenging to treat chronic pain condition can occur from complications to recovery from surgeries such as knee arthroscopy, foot surgery or hernia surgery,” added Dr. Jason Pope of Santa Rosa, Calif.-based Sutter Santa Rosa Surgery & Endoscopy Center, another 1st implanter for Axium. “Having a treatment option rooted in clinical evidence fundamentally changes our approach to treating patients. I am thrilled to be among the 1st in the United States to offer previously underserved patients this revolutionary technology.”

The post St. Jude Medical’s Axium chronic pain device makes its U.S. debut appeared first on MassDevice.



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