![]() Note: The INFUSE Bone Graft is also known as bone morphogenic, or morphogenetic protein-2, BMP-2. The INFUSE Bone Graft is considered medically necessary for treating skeletally mature persons with acute, open tibial shaft fractures that have been stabilized with intramedullary nail fixation after appropriate wound management, when INFUSE Bone Graft is applied within 14 days after the initial fracture.Īetna considers the INFUSE Bone Graft experimental and investigational for all other indications, including its use in ankle fusions and cervical fusions, because its effectiveness for indications other than the ones listed above has not been established. INFUSE Bone Graft and device is to be implanted via an anterior (ALIF) or lateral (OLIF, DLIF, XLIF or LLIF) approach.INFUSE Bone Graft is to be used with a cage (for example, the MedtronicTitanium Threaded Interbody Fusion Device, the LT-CAGE Lumbar Tapered Fusion Device, or the INTER FIX or INTER FIX RP Threaded Fusion Device) and.The member meets medical necessity criteria for lumbar spinal fusion in CPB 0743 - Spinal Surgery: Laminectomy and Fusion and.INFUSE Bone Graft (Bone Morphogenic Protein-2)Īetna considers the INFUSE Bone Graft medically necessary for lumbar spinal fusion procedures in skeletally mature persons who meet the following criteria:.Abbott beats The Street in Q3 on stronger U.S.Number: 0411 Table Of Contents Policy Applicable CPT / HCPCS / ICD-10 Codes Background References.Sinaptica’s neurostim treatment for Alzheimer’s wins FDA breakthrough nod. ![]() GE Healthcare, AMC Health partner on remote monitoring.Medtronic expands global access to robotic-assisted surgery with three new global indication expansions.FDA clears HeartFlow’s AI-powered analysis tech.Philips Respironics CPAP, BiPAP mask recall is Class I.Outset Medical unveils TabloCart for Tablo hemodialysis system.Nuwellis appoints new CFO following $11M public offering.Ablation is the next step for Intuitive’s Ion system.Medtronic unveils new neurovascular innovation incubator program.FDA clears AI-enabled MR tech from Philips.Depuy Synthes wins FDA clearance for Teligen system. ![]() 3M Oral Care launches custom matrix for restorative procedures.Life Spine announces first implant of ProLift Micro endoscopic expandable spacer system.New Philips CEO says he is ‘deeply sorry’ over Respironics recall.Sam Wu joined Cerapedics’s board of directors.įiled Under: Funding Roundup, News Well, Spine Tagged With: Cerapedics Inc., Orthobiologics "Cerapedics is well-positioned to become a key player in the nearly $2 billion osteobiologics marketplace across spine, trauma and orthopedic reconstruction worldwide."Ĭerapedics also said the FDA) gave the green light to a modular pre-market approval submission for the IDE behind i-Factor "and has commenced that process."Īs part of the funding round, MedImmune managing director Dr. It is a direct reflection of the merits of the clinically tested i-Factor product portfolio and the team we have put in place globally," president & CEO Paul Mraz said in prepared remarks. "We are gratified with the response received from the financial community given the challenging economic environment present industry-wide. ![]() ![]() "The proceeds will also allow Cerapedics to accelerate the development of next-generation products and continue investments in sales and marketing to meet demand for the company’s i-Factor bone graft outside the United States," the Westminster, Colo.-based company said. Cerapedics said it closed a Series C equity round worth $19 million, led by new investors MedImmune Ventures and CVF LLC, an affiliate of Henry Crown & Co.Įxisting backers OrbiMed Advisors and NGN Capital also participated, according to a press release.Ĭerapedics said it plans to spend the proceeds on the investigation device exemption trial of its i-Factor peptide-enhanced bone graft technology, which is designed to treat problems in the cervical spine "and prepare for commercialization upon FDA approval," according to the release. ![]()
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