SAN JOSE, Calif., Sept. 25, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company which pioneered the use of the iFuse Implant System^® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of one-year results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis; ClinicalTrials.gov ID NCT01741025).  iMIA is a randomized controlled trial, conducted at 9 hospitals in 4 countries in Europe, that assessed the safety and effectiveness of SI joint fusion with the iFuse Implant compared to conservative management (CM) in patients with chronic SI joint dysfunction.  This Level 1 study was published in Pain Physician, the official journal of the American Society of Interventional Pain Physicians and titled 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint¹.  The study showed that for patients with chronic low back pain (LBP) due to certain types of SI joint dysfunction, minimally invasive SI joint fusion with the iFuse Implant was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life at one year.  The full article can be found at the following link: http://www.painphysicianjournal.com/current/pdf?article=NDYwOQ%3D%3D

The study included 109 subjects enrolled between June, 2013 and May, 2015 and follow-up for this publication extends through October, 2016.  Mean age was 48.1 years, 75 subjects (72.8%) were women and mean SI joint pain duration was 4.7 years.  Most (72.8%) had undergone prior SI joint steroid injections, a minority (16.5%) had had prior radiofrequency ablation and about 1/3 (35.9%) had undergone prior lumbar fusion, a known risk factor for SI joint pain.  Patients in the surgical arm of the study were treated with the iFuse Implant, which has been commercially available in the United States since 2009.

As shown in the figures below, at one year, mean LBP improved by 41.6 VAS points (0 – 100 VAS pain scale) in the SI joint fusion group compared to 14.0 points in the CM group (Figure 1), and the mean Oswestry Disability Index (ODI) improved by 25.0 points in the SI joint fusion group compared to 8.7 points in the CM group (Figure 2).  Also, mean improvements in leg pain and EQ-5D-3L were large after SI joint fusion and superior to those after CM.  CM subjects were allowed to cross over to SI joint fusion after six months and subjects who crossed over to surgical treatment had no pre-crossover improvement in pain and ODI scores.  After crossover, improvements in most measures were as large as those patients originally assigned to SI joint fusion.

“It’s been most gratifying to be a part of this important trial to help identify the value and benefits of the use of the iFuse Implant for SI joint patients who no longer benefit from conservative therapies,” said Bengt Sturesson, MD, from Ängelholm Hospital, Ängelholm, Sweden and one of the study authors.  “The one-year results from iMIA clearly show consistent outcomes with the previously published U.S. RCT, INSITE, thus further validating the applicability of the iFuse Implant to patients across a broad spectrum of clinical practitioners.”

Aaron Calodney, MD of Texas Spine & Joint Hospital in Tyler, TX said, “as a member and past president of the American Society of Interventional Pain Physicians, I am delighted to see such a high-quality study be published in the Pain Physician journal.  In addition, I continue to be impressed with both the quantity and quality of the clinical evidence being generated that clearly separates the iFuse Implant from all other SI joint surgical options.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁶ Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections to confirm the diagnosis.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9760.092517

SOURCE SI-BONE, Inc.

SUNNYVALE, Calif., Sept. 19, 2017 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately held medical device company that has developed the Intracept® Procedure, a minimally invasive and clinically proven approach for the treatment of chronic low back pain, announced today that Kevin Hykes has been appointed President and Chief Executive Officer as well as a member of the Board of Directors, effective immediately. Alex DiNello, the Company’s CEO since 2011, will remain an integral member of the management team as Chief Operating Officer.

Mr. Hykes joins Relievant from Metavention, a clinical-stage medical device company developing interventional therapies for the treatment of type 2 diabetes, where he was Chairman and CEO as well as an Operating Partner at Versant Ventures. He is remaining as Chairman of the Board of Directors at Metavention. Mr. Hykes was previously President and CEO of Cameron Health, developer of the first subcutaneous implantable defibrillator, until its acquisition by Boston Scientific in 2012. Prior to Cameron Health, he was the Chief Commercial Officer of Visiogen, Inc., a privately held ophthalmology company which was acquired by Abbott Medical Optics in 2009. Previously, Mr. Hykes spent sixteen years at Medtronic, where he held leadership positions in the Cardiac Rhythm Management (CRM), Neurological, Heart Valve, and Cardiac Surgery businesses in the U.S. and Europe.

“Kevin is a highly respected industry veteran with an exceptional track record of building and leading strong teams, rapidly growing businesses, and developing markets for groundbreaking, PMA-class devices. Kevin’s experience and track record commercializing medical technologies around the world will be a significant asset as he leads Relievant into the next phase of its growth,” said Richard Mott, Executive Board Chairman of Relievant. “On behalf of the entire Board of Directors, we thank Alex for his contributions which have created a solid foundation for the company’s future success. We look forward to his continued leadership as our Chief Operating Officer.”

“I am thrilled to join Relievant and am impressed by what the company has accomplished to date.  The results of the SMART Trial, the medical device industry’s first successful Level 1, randomized sham-controlled trial for chronic low back pain, demonstrate the significant potential for the Intracept Procedure to fill a critical gap in the treatment continuum for chronic low back pain, and to provide physicians and patients with a much-needed new solution,” said Kevin Hykes. “I look forward to working with the Relievant team to deliver on our mission to improve the quality of lives for millions of patients suffering from this disabling condition.”

About Relievant Medsystems

Founded in 2006 and based in Sunnyvale, California, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from chronic low back pain. Relievant’s Intracept® System delivers targeted energy into the spine and blocks the transmission of pain signals from the basivertebral nerve (BVN).  This minimally invasive procedure provides orthopedic surgeons, neurological surgeons and interventionalists with a new way to provide clinically proven, lasting pain relief for chronic low back pain.  As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please see www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

FDA has cleared the Intracept System for the following Indications for Use:   The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

* Surgical Multi-Center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

Contact
Lynn Lewis or Carrie Mendivil
Gilmartin Group
415-937-5402
investors@relievant.com

BRISBANE, AUSTRALIA (PRWEB) SEPTEMBER 14, 2017

AxioMed is pleased to announce the success of the first viscoelastic Freedom Lumbar Disc case in Australia. Dr. Steven Yang completed the procedure on a 35-year-old female patient suffering from degenerative disc disease with radiating pain as a result of a degenerative lumbar disc at level L5-S1. The patient failed conservative treatments prior to undergoing surgery.

Dr. Yang spoke to the advantages of the AxioMed Disc after the operation, stating, “The Freedom Lumbar Disc is a great implant. It’s a very easy system to use and the compressible viscoelastic core restores the natural motion in the lumbar spine. My patient was pain free and out of the hospital in two days.”

AxioMed President Jake Lubinski personally met with Dr. Yang months before the surgery. “Dr. Yang’s disc replacement expertise led him to deciding the AxioMed Disc is the best treatment for his patients because it restores natural motion in the spine which ball-and-socket disc replacement cannot do.” Lubinski added, “With the addition of the viscoelastic lateral lumbar technique, we expect AxioMed to be the worldwide leader in disc replacement surgery.”

Dr. Yang is an orthopedic spinal surgeon specializing in complex spine reconstruction and vertebral tumor surgery, as well as all aspects of adult and pediatric spine surgery. Prior to joining his current practice – BrizBrain & Spine – in 2013, Dr. Yang was director of orthopedic surgery and director of spine surgery fellowship at the Royal Brisbane and Women’s Hospital.

View motion footage of the AxioMed Freedom Lumbar Disc here.

About AxioMed 
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® Disc through clinical studies in the U.S. and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.