{"id":470936,"date":"2021-04-05T11:07:57","date_gmt":"2021-04-05T15:07:57","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=470936"},"modified":"2021-04-05T11:07:57","modified_gmt":"2021-04-05T15:07:57","slug":"nevro-announces-publication-of-landmark-senza-pdn-clinical-trial-results-in-jama-neurology","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nevro-announces-publication-of-landmark-senza-pdn-clinical-trial-results-in-jama-neurology\/","title":{"rendered":"Nevro Announces Publication Of Landmark SENZA-PDN Clinical Trial Results In JAMA Neurology"},"content":{"rendered":"
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Level I Randomized Clinical Trial Demonstrates Significantly Improved and Sustained Outcomes with 10 kHz Spinal Cord Stimulation<\/h2>\n

Patients Suffering from Painful Diabetic Neuropathy Experienced Substantial, Sustained Pain Relief and Improved Health-Related Quality of Life<\/h2>\n

Durability of 10 kHz Spinal Cord Stimulation Shown Over 6 Months<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n REDWOOD CITY, Calif.<\/span>, April 5, 2021<\/span> \/PRNewswire\/ — Nevro Corp.\u00a0(NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced\u00a0that results of its SENZA-PDN randomized clinical trial (RCT) were published online in\u00a0JAMA Neurology<\/i>.\u00a0 Data from the SENZA-PDN trial formed the basis of the company’s recent PMA supplement submission to the U.S. Food and Drug Administration (FDA) for use of the Senza\u00ae System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).\u00a0 If approved, the Senza System would be the only spinal cord stimulation (SCS) system FDA approved with a specific on-label indication for treating PDN.\u00a0 <\/p>\n

The JAMA Neurology <\/i>publication can be accessed at:
https:\/\/jamanetwork.com\/journals\/jamaneurology\/fullarticle\/10.1001\/jamaneurol.2021.0538?guestAccessKey=aac5074b-819f-48cc-a293-5e17e3084b56&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=040521<\/a>\u00a0 <\/p>\n

In addition, a JAMA Neurology<\/i> podcast featuring Dr. Erika Petersen<\/span>, Professor of Neurosurgery, Director of Functional and Restorative Neurosurgery at the University of Arkansas<\/span> for Medical Sciences, and lead investigator of the study is also available at:
https:\/\/edhub.ama-assn.org\/jn-learning\/audio-player\/10.1001\/jamaneurol.2021.559<\/a><\/p>\n

“It’s been an honor to lead this clinical study showing the significant benefit of 10 kHz spinal cord stimulation for PDN patients who have suffered for years with refractory symptoms,” stated Dr. Erika Petersen<\/span>.\u00a0 “The substantial pain relief and improved quality of life sustained over six months demonstrates that this therapy can safely and effectively treat this patient population. \u00a0I’m grateful to my co-investigators and the patients who participated in this study, as the results will have far-reaching impact on the lives of PDN patients.”<\/p>\n

“No conventional, low-frequency SCS treatments have been thoroughly evaluated or demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to offer our innovative treatment option to patients who are unable to find relief with currently available pharmacologic options,” said D. Keith Grossman<\/span>, Chairman, Chief Executive Officer and President of Nevro. \u00a0“A six-month review cycle by the FDA could position the company to achieve approval and initiate U.S. launch activities to provide HF10\u00ae therapy for the treatment of chronic pain in PDN patients during the second half of 2021.”<\/p>\n

The randomized SENZA-PDN study met its prespecified primary endpoint demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS.\u00a0 The study also demonstrated statistical significance in seven of eight prespecified secondary endpoints showing clear differences from the best available medical treatments.\u00a0 This safety and efficacy data will be used to support physician referral decisions as well as our market access initiatives to ensure adequate payer coverage of this procedure.\u00a0 The SENZA-PDN RCT results were previously presented during the plenary session at the 2021 North American Neuromodulation Society (NANS) Virtual Meeting in January.\u00a0 <\/p>\n

\n An investor presentation is available in the “Investor Relations” section of Nevro’s website at www.nevro.com<\/a>.<\/b>\n <\/p>\n

\n About the SENZA-PDN RCT<\/b>\n <\/p>\n

Nevro’s SENZA-PDN study, the largest RCT of spinal cord stimulation treatment conducted for PDN, compares 10 kHz SCS plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States<\/span>. \u00a0The primary endpoint of the study is a composite endpoint that includes the difference in proportion of treatment responders without deterioration of neurological deficits at 3-month follow-up. Study participants continue to be followed out to 24 months. The SENZA-PDN RCT six-month data show sustained effectiveness of 10 kHz SCS versus CMM and demonstrated the following benefits:<\/p>\n

\n Pain:<\/b>\n <\/p>\n