Sam Brusco, Associate Editor04.05.23
Abryx, a biomaterial sciences company focused on therapeutic technologies for surgical procedures, has earned additional U.S. Food and Drug Administration (FDA) clearances for its MONTAGE settable, resorbable bone putty as both a bone void filler and cranial bone cement.
MONTAGE is a hand-moldable, hardening putty that offers intraoperative utility and achieves bone-like properties within minutes of mixing and application. The clearances follow MONTAGE’s clinical introduction for use on bleeding bone.
"These expanded clearances for MONTAGE reflect its versatility, which is derived from its unique, self-setting and absorbable polymer. The product already has an impressive track record, with more than 22,000 uses since its initial FDA clearance, and we expect that these latest clearances will support its expanded use across more applications," John J. Pacifico, founding president and CEO of Abyrx told the press. "This important milestone is a testament to the dedicated efforts of Abyrx's excellent scientific and regulatory teams, whose work is expanding the number and type of patients who have access to the benefits of MONTAGE."
MONTAGE aims to replace traditional settable calcium phosphate/sulfate and magnesium-based products, which tend to be brittle. The proprietary polymer allows MONTAGE to be moldable and shapeable during the hardening process and machined using standard tools found in operating rooms.
After surgery, MONTAGE is engineered to resorb during bone modeling and be replaced by bone. Because MONTAGE is cohesive, adheres to bone, and hardens, it may be used to help stabilize bone fragments and primary fixation hardware constructs during the procedure. The product can also be drilled and tapped, and hardware can be placed through it at any time during the setting process.
MONTAGE is a hand-moldable, hardening putty that offers intraoperative utility and achieves bone-like properties within minutes of mixing and application. The clearances follow MONTAGE’s clinical introduction for use on bleeding bone.
"These expanded clearances for MONTAGE reflect its versatility, which is derived from its unique, self-setting and absorbable polymer. The product already has an impressive track record, with more than 22,000 uses since its initial FDA clearance, and we expect that these latest clearances will support its expanded use across more applications," John J. Pacifico, founding president and CEO of Abyrx told the press. "This important milestone is a testament to the dedicated efforts of Abyrx's excellent scientific and regulatory teams, whose work is expanding the number and type of patients who have access to the benefits of MONTAGE."
MONTAGE aims to replace traditional settable calcium phosphate/sulfate and magnesium-based products, which tend to be brittle. The proprietary polymer allows MONTAGE to be moldable and shapeable during the hardening process and machined using standard tools found in operating rooms.
After surgery, MONTAGE is engineered to resorb during bone modeling and be replaced by bone. Because MONTAGE is cohesive, adheres to bone, and hardens, it may be used to help stabilize bone fragments and primary fixation hardware constructs during the procedure. The product can also be drilled and tapped, and hardware can be placed through it at any time during the setting process.