The FDA approval expands the surgical applications of MONTAGE, a unique mouldable bone putty that was previously approved as a bone void filler, cranial cement, and haemostatic bone putty, to include cardiothoracic surgery after sternotomy
FDA expands the approval for MONTAGE bone putty. (Credit: Nino Liverani on Unsplash)
US-based biomaterial sciences company Abyrx has received the US Food and Drug Administration (FDA) expanded approval for its MONTAGE settable bone putty product.
MONTAGE is a unique mouldable bone putty that adheres to bleeding bone and hardens quickly to deliver bone-like properties after application.
It was previously approved as a bone void filler, cranial cement, and haemostatic bone putty.
The current FDA approval expands its surgical applications to include the use in cardiothoracic surgery after sternotomy.
Abyrx said that MONTAGE is the first FDA-approved settable bone putty on the sternum.
Abyrx founder and chief executive officer John J Pacifico said: “When we initially set a course to develop the MONTAGE technology platform, we believed its polymer backbone had unique capabilities that could ultimately support the use of the product as a new standard of care for treating bone defects during surgical procedures.
“Today, we see the product’s impressive breadth of indications enabling widespread, on-label use of MONTAGE across surgical specialities that represent millions of procedures each year.
“We believe MONTAGE has the potential to eliminate the need or desire for all other settable and non-settable biomaterials used on bone.”
According to Abyrx, more than 25,000 units of MONTAGE have been used to date, across trauma, orthopaedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.
Surgeons preferred MONTAGE over other bone putties due to its extensive FDA-approved applications, safe and reproducible performance, and intraoperative handling benefits.
University of Calgary Libin Cardiovascular Institute director, cardiac surgeon, and translational scientist, Paul Fedak, led a single-centre pilot study, conducted in partnership with Abyrx.
The study evaluated the feasibility, safety, and efficacy of MONTAGE in 60 patients.
Its results showed that patients treated using MONTAGE with wire cerclage experienced improved physical functional recovery, reduced pain, and shortened hospital stays.
The biomaterial company is also assessing the long-term outcomes and sternal integrity with MONTAGE, post-surgery using rigorous patient follow-up and radiographic imaging.
Fedak said: “This clearance marks a new frontier for cardiothoracic surgery and addresses a longstanding clinical gap where important technological innovation has been stagnant for more than 60 years.
“Standard sternal (breastbone) closure techniques use simple mechanical fixation devices such as wires and plates to provide mechanical support until the bone heals naturally over 8-12 weeks.
“The broken breastbone causes pain and delays recovery. MONTAGE is a breakthrough product that has the potential to enable heart surgeons to enhance sternal closure and repair and accelerate patient recovery after surgery.”