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News Article | May 8, 2017
Site: www.prnewswire.com

"It gives me great pride to announce that the iFuse ProcedureTM is considered a proven treatment by the United States Defense Health Agency and can now be appropriately offered to active and retired military personnel and their family members," said Michael Mydra, SI-BONE's Vice President, Health Outcomes & Reimbursement.  "SI-BONE is pleased to be able to help all the brave men and women in our armed forces for their service to our country." "Earlier this year, we met with Colonel Stephen C. Phillips, DO, MPH and his staff at the Defense Health Agency in Washington, D.C. and reviewed the extensive published clinical evidence for the iFuse Implant.  Following that meeting, the TRICARE policy team determined that coverage for MIS sacroiliac joint fusion was appropriate and warranted," said Tony Recupero, Chief Commercial Officer at SI-BONE.  "We are now fully engaged with physicians at military facilities across the country to assist them in providing iFuse to appropriately diagnosed military personnel." The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 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 misattributed 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 Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections. 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 ImplantTM 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 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 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 CPT copyright 2017 America Medical Association.  All rights reserved.  CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9876.050817 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/si-bone-inc-announces-us-militarys-tricare-now-covers-mis-si-joint-fusion-300452667.html


The policy specifically states that "use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFuse Implant System) is considered experimental, investigational and/or unproven."  In other words, only the iFuse Implant System is considered a proven MIS SI joint fusion procedure and is covered by the policy. Blue Cross and Blue Shield® (BCBS) plans of Illinois, Montana, New Mexico, Oklahoma and Texas, under the umbrella of HCSC, is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, covering approximately 15 million lives. The iFuse exclusive positive coverage policy, which originally became effective January 1, 2017, is based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse ImplantsTM for SI joint fusion.  The policy has been further strengthened with additional iFuse Implant publications demonstrating the safety and effectiveness of the iFuse ProcedureTM.  The BCBS plans in Illinois, Montana, New Mexico, Oklahoma and Texas join SelectHealth in Utah and Geisinger in Pennsylvania as a growing number of commercial health plans to offer exclusive positive coverage for the iFuse Implant System. Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: "this exclusive coverage policy update by the five Blue Cross and Blue Shield plans in Illinois, Oklahoma, New Mexico, Montana and my home state of Texas further validates the strength of the clinical evidence supporting the iFuse Implant System as the only minimally invasive SI joint fusion device with appropriate and sufficient data to support coverage." 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 pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5  Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side. SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it.  While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test.  The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint. About the iFuse Implant System The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint's unique motion of nutation.  The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth6, facilitating long-term fusion of the joint.  The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life. 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 About SI-BONE, Inc. SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9954.080217


The focus of the review was to outline the diagnostic value of signs and symptoms for use in primary care without access to additional more expensive and invasive confirmatory tests.  The intent was to provide an evidence-based clinical diagnosis with acceptable accuracy that may reduce the need for invasive or expensive diagnostic methods.  In a primary care setting, the clinical prediction rule for the diagnosis of SI joint pain, using a cluster of 3 of 5 positive provocative maneuvers in the absence of known discogenic or radicular pain, and dominant pain localized over the posterior superior iliac spine (PSIS), are as good or in most cases better than the clinical prediction rules for other lumbar spine conditions. "The takeaway of this review is that physical exam findings for the SI joint are more predictive of a positive SI joint block than most other physical exam tests for other low back conditions," said Mark Laslett, PhD, one of the study authors.  "While controlled and guided intra-articular SI joint blocks are the best reference standard test for intra-articular SI joint pain, positive provocation SI joint tests in patients known to have no other obvious source of pain, is a reliable and validated diagnostic process that primary care clinicians can predicate referral for surgical opinion and more invasive diagnostic workup." 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 pain2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.6  Patients with SI joint disorders may feel pain in the lower back, buttocks and/or legs localized over the posterior superior iliac spine (PSIS). This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side. SI joint pain is often misdiagnosed or misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it.  SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test.  The diagnosis is confirmed with an appropriate physical examination and image-guided diagnostic injections directly in the SI joint. About the iFuse Implant System The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint's unique motion of nutation.  The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth7, facilitating long-term fusion of the joint.  The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life. 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 About SI-BONE, Inc. SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9956.080917


Patent
Si Bone Inc. | Date: 2017-07-26

Implants for the fusion or fixation of two bone segments are described. For example, the implants can be used for the fusion or fixation of the sacroiliac joint. The implants can have a matrix structure, have a rectilinear cross-sectional area, and have a curvature.


"We are very pleased to learn that Blue Cross Blue Shield of Vermont has established a positive coverage policy based on the published peer-reviewed clinical evidence for patients with SI joint related low back or buttock pain who essentially meet the NASS coverage criteria for MIS SI joint fusion," said Michael Mydra, Vice President, Health Outcomes & Reimbursement at SI-BONE. 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 pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 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 misattributed 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 Sign, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections. 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 ImplantTM 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 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 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. 9929.061217 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/si-bone-inc-announces-blue-cross-and-blue-shield-of-vermont-establishes-positive-coverage-policy-for-mis-sacroiliac-joint-fusion-300472133.html


The iFuse-3D Implant's surface and fenestrated structure were designed to provide enhanced osteointegration and promote intra-articular fusion.  A study, published on June 1, 2017, in the International Journal of Spine Surgery (IJSS) titled: Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants1 shows significant bone growth on and into the implant's porous surface (Figure 1) as well as through its fenestrations (Figure 2). Scott Yerby, Chief Technology Officer at SI-BONE, commented, "The design and development of the iFuse-3D implant was a multi-year effort.  Our goal was to expand the iFuse family using 3D-printing technology to provide enhanced surface characteristics while retaining key performance features of the iFuse Implant, including superior rotational resistance, mechanical strength and ease of use with our existing instrumentation.  iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than our highly successful iFuse Implant.  Additionally, the structural fenestrations allow complete bone through growth." "The iFuse-3D Implant embodies our commitment to advancing the diagnosis and treatment of chronic SI joint disorders through innovative products, procedures and educational programs in order to help patients suffering from chronic SI joint pain," said Jeffrey Dunn, President and CEO of SI-BONE.  "Our team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the iFuse Implant, and we believe that expanding the iFuse family has the potential to help thousands more patients.  What can be more exciting and rewarding than that?" On May 30, 2017, the U.S. Patent and Trademark Office issued patent no. 9,662,157 covering various structural design features of the iFuse-3D Implant that will extend intellectual property protection of the unique implant design for 17 years until September 2035. 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 pain2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.6  Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side. SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it.  While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test.  The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint. About the iFuse Implant System The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The patented triangular implant shape and patented press fit insertion technique are designed to provide immediate fixation by minimizing the SI joint's unique motion called nutation.  The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth1, facilitating long-term fusion of the joint.  The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life. 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 About SI-BONE, Inc. SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9848.061317 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/si-bone-inc-announces-fda-clearance-and-full-us-commercial-launch-of-the-ifuse-3d-implant-a-patented-3d-printed-next-generation-member-of-the-ifuse-implant-system-300472718.html


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 pain2-5, 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


Systems, devices, and methods for diagnosing and treating conditions of the spine employ a garment for selectively positioning vertebrae of a spine of a supine individual, e.g., during diagnostic imaging of the spine. The garment affects movement of vertebrae that can be diagnostically correlated with incidents of back pain.


Patent
Si Bone Inc. | Date: 2012-11-12

A stem-like bone fixation device allows for bony in-growth on its surface and across fracture fragments or between bones that are to be fused.


Patent
Si Bone Inc. | Date: 2011-04-01

A joint between two bone segments is fused by passing an elongated, rectilinear bone fusion device over a guide pin across the joint and into tight engagement within bores formed in the bone segments, to thereby restrict movement of the elongated bone fusion device across the joint. The elongated, rectilinear bone fusion device also provides bony in-growth within the bores along the exterior surface of the bone fusion device.

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