SAN JOSE, Calif., June 15, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Geisinger Health Plan, a commercial health plan covering more than 500,000 lives in the states of Delaware, Maine, New Jersey, Pennsylvania, and West Virginia has issued a revised medical policy for SI joint fusion that exclusively covers the iFuse Implant System "for the treatment of SI joint syndrome and SI joint mediated mechanical low back pain" when the five diagnostic criteria recommended by the International Society for the Advancement of Spine Surgery (ISASS) are met. The policy becomes effective June 15, 2016, and further states: "the use of minimally invasive fusion products other than iFuse Implant System for sacroiliac joint fusion is considered experimental/investigational or unproven and therefore NOT COVERED." The complete policy can be found at: https://www.thehealthplan.com/Providers_Unsecured/ClinicalPolicies/Medical_Policies/Current_Policies/MP301_Sacroiliac_Joint_Fusion/
Geisinger's exclusive iFuse coverage policy further distinguishes iFuse from all other SI joint fusion technologies which are predominantly round, screw-based systems.
iFuse's unique patented triangular shape provides 31 times the rotational resistance of a screw. It is the only commercially available SI joint fusion device in the United States with published evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter prospective studies, two of which are randomized controlled trials (RCTs). Currently, there are more than 40 peer reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic value of iFuse. It is the only SI joint fusion product with a unique FDA clearance recognizing that clinical studies demonstrate improved pain, patient function and quality of life.
"Payors are increasingly requiring robust safety and effectiveness evidence, to include prospective and randomized controlled trials, that demonstrate significant patient improvement and long-term durability. iFuse is clearly the ONLY MIS SI joint fusion technology supported by prospective studies, including two RCTs, that demonstrate significant patient improvement and long-term durability; hence, we are seeing innovative leading-edge payors like Geisinger make iFuse the ONLY MIS SI joint fusion option available for their health plan members," said Michael Mydra, Vice President, Health Outcomes & Reimbursement, SI-BONE.
"I am very pleased to see the Geisinger Health Plan establish an exclusive coverage policy for iFuse based on the strength of clinical and economic evidence," said Dr. Matthew R. Eager, from Pennsylvania. "This decision provides an important treatment option for patients who fail to respond to non-surgical treatment for various SI joint conditions and will reduce the need for costly repeated interventions. I appreciate the health plans medical directors' willingness to discuss this specific treatment with me and consider this important policy change. I hope other health plans follow Geisinger's lead and establish exclusive coverage policies for iFuse to provide this important clinically proven technology to those patients suffering from certain types of SI joint dysfunction."
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. 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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. 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. ©2016 SI-BONE, Inc. All Rights Reserved. 9650.061516
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SOURCE SI-BONE, Inc.