Sam Brusco, Associate Editor09.26.23
Abyrx, a biomaterial sciences firm developing therapeutic technologies for use in surgery, has been granted U.S. Food and Drug Administration (FDA) clearance for its MONTAGE settable bone putty for use in cardiothoracic surgery, following sternotomy.
The company said this is the first time the FDA has granted clearance for using a settable bone putty on the sternum. It follows previous FDA clearances for MONTAGE as a bone void filler, cranial cement, and hemostatic bone putty.
MONTAGE moldable putty adheres to bleeding bone and quickly hardens to achieve bone-like properties after being applied.
"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," Dr. Paul Fedak, MD Ph.D., cardiac surgeon, translational scientist and director of the Libin Cardiovascular Institute, University of Calgary, told the press. "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 potential to enable heart surgeons to enhance sternal closure and repair and accelerate patient recovery after surgery. The product is applied to the separated sternum in a putty-like consistency. Upon application, MONTAGE controls bleeding and eliminates the need for topical agents known to prevent bone healing, such as bone wax. Following closure, MONTAGE hardens and has been shown in a pilot clinical study to potentially accelerate patient recovery and reduce pain. I predict that sternal closure using MONTAGE settable bone putty will become a standard of care for patients undergoing heart surgery through the breastbone and will significantly improve recovery and meaningful clinical outcomes."
Abyrx founder and CEO John J. Pacifico added, "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 specialties 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 as it is easy to use, can be molded and shaped to conform to varying anatomy, hardens with bone like properties even in the presence of irrigation and bleeding, and has been shown to resist brittle fracture and disintegration over time as it is replaced by bone during the remodeling process."
The company said this is the first time the FDA has granted clearance for using a settable bone putty on the sternum. It follows previous FDA clearances for MONTAGE as a bone void filler, cranial cement, and hemostatic bone putty.
MONTAGE moldable putty adheres to bleeding bone and quickly hardens to achieve bone-like properties after being applied.
"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," Dr. Paul Fedak, MD Ph.D., cardiac surgeon, translational scientist and director of the Libin Cardiovascular Institute, University of Calgary, told the press. "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 potential to enable heart surgeons to enhance sternal closure and repair and accelerate patient recovery after surgery. The product is applied to the separated sternum in a putty-like consistency. Upon application, MONTAGE controls bleeding and eliminates the need for topical agents known to prevent bone healing, such as bone wax. Following closure, MONTAGE hardens and has been shown in a pilot clinical study to potentially accelerate patient recovery and reduce pain. I predict that sternal closure using MONTAGE settable bone putty will become a standard of care for patients undergoing heart surgery through the breastbone and will significantly improve recovery and meaningful clinical outcomes."
Abyrx founder and CEO John J. Pacifico added, "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 specialties 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 as it is easy to use, can be molded and shaped to conform to varying anatomy, hardens with bone like properties even in the presence of irrigation and bleeding, and has been shown to resist brittle fracture and disintegration over time as it is replaced by bone during the remodeling process."