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Data from the first postmarket safety report of OssDsign’s OssDsign Catalyst revealed that, from product launch in August 2021 through August 2022, the product did not record any device related complaints nor device related adverse events.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. Similar to the body’s own bone mineral structure, the nanocrystalline structure of OssDsign Catalyst provides a favorable bone biology environment inducing rapid and reliable bone formation. The postmarket safety review shows that 511 units of OssDsign Catalyst have been sold since the product launch in August 2021. During this time, no device related complaints nor device related adverse events have been reported.
U.S. regulatory clearance is based on preclinical results that surpass other synthetic bone grafts in the most established and demanding pre-clinical model for spinal fusion, the Boden model. To collect clinical data, OssDsign is currently running PROPEL, a U.S. based multi-center prospective spinal fusion registry. In parallel, the company is conducting the clinical trial TOP FUSION in Hungary, in which patient enrollment was completed in April 2022, with patient follow-up over 24 months under the leadership of world-leading experts in spinal surgery.
“When a new product is launched, surgeons will always ask about the safety of usage. This postmarket safety review strongly supports the safety profile of OssDsign Catalyst and gives me high confidence in the product going forward. Together with our ongoing clinical trial TOP FUSION and our patient registry PROPEL, solid data like this continues to strengthen our competitiveness on the U.S. market,” said Morten Henneveld, CEO.
Source: OssDsign
Data from the first postmarket safety report of OssDsign's OssDsign Catalyst revealed that, from product launch in August 2021 through August 2022, the product did not record any device related complaints nor device related adverse events.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in...
Data from the first postmarket safety report of OssDsign’s OssDsign Catalyst revealed that, from product launch in August 2021 through August 2022, the product did not record any device related complaints nor device related adverse events.
OssDsign Catalyst is a nanosynthetic bone graft that stimulates the formation of healthy bone tissue in spinal fusion surgeries. Similar to the body’s own bone mineral structure, the nanocrystalline structure of OssDsign Catalyst provides a favorable bone biology environment inducing rapid and reliable bone formation. The postmarket safety review shows that 511 units of OssDsign Catalyst have been sold since the product launch in August 2021. During this time, no device related complaints nor device related adverse events have been reported.
U.S. regulatory clearance is based on preclinical results that surpass other synthetic bone grafts in the most established and demanding pre-clinical model for spinal fusion, the Boden model. To collect clinical data, OssDsign is currently running PROPEL, a U.S. based multi-center prospective spinal fusion registry. In parallel, the company is conducting the clinical trial TOP FUSION in Hungary, in which patient enrollment was completed in April 2022, with patient follow-up over 24 months under the leadership of world-leading experts in spinal surgery.
“When a new product is launched, surgeons will always ask about the safety of usage. This postmarket safety review strongly supports the safety profile of OssDsign Catalyst and gives me high confidence in the product going forward. Together with our ongoing clinical trial TOP FUSION and our patient registry PROPEL, solid data like this continues to strengthen our competitiveness on the U.S. market,” said Morten Henneveld, CEO.
Source: OssDsign
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
