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HomeFDASIGNAFUSE Bioactive Bone Graft Receives FDA Clearance

SIGNAFUSE Bioactive Bone Graft Receives FDA Clearance

June 25, 2020

SIGNAFUSE Bioactive Bone Graft in a new strip format receives FDA Clearance reports Bioventus. The strips consist of 55% bioglass by weight and have been shown to induce higher levels of osteoblast differentiation compared to other synthetic bone graft strips.1

SIGNAFUSE Bioactive bone graft has been available as a putty since 2014; the new strips hydrate rapidly and provide exceptional handling properties for intraoperative flexibility. They come in multiple sizes ranging from 25 to 200 millimeters in length, with the longer strips providing a great option for large, multilevel procedures.

The biphasic mineral in SIGNAFUSE is composed of 60% hydroxyapatite and 40% beta- tricalcium phosphate; a ratio supported by multiple prospective2 and randomized controlled trials.3-5

“We are excited to expand our portfolio of bone graft solutions with the SIGNAFUSE Bioactive Bone Graft strip,” said Megan Osorio, Vice President, Marketing, Bioventus. “Apart from the ideal combination of biomaterials that contribute to healing, and best-in-class handling, this product is unique in that it offers a great solution for patients that require more significant interventions such as spinal deformity correction.”

“We also believe SIGNAFUSE in the strip format will provide efficiencies for the hospital, either by opening fewer packages or cost savings opportunities vs. alternative grafts,” added John Nosenzo, Chief Commercial Officer, Bioventus.

The new strip format of SIGNAFUSE will be available in Q3 from our distributor partners across the country.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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