AmericanHHM
KP - Pentamed® - High performance packaging films for medical devices

Innovative MONTAGE® Bone Putty by Abyrx Secures FDA Approval for Cardiothoracic Surgery

Abyrx, a leading company specializing in biomaterial sciences and therapeutic technologies for surgical applications, has recently achieved a significant milestone. The United States Food and Drug Administration (FDA) has granted regulatory clearance for Abyrx's pioneering product, the MONTAGE® Settable Bone Putty, specifically for use in cardiothoracic surgery following sternotomy. This marks a historic moment as it is the first time the FDA has granted clearance for the application of a settable bone putty on the sternum. This achievement builds upon Abyrx's previous FDA clearances for the versatile MONTAGE product, which includes its use as a bone void filler, cranial cement, and hemostatic bone putty.

Beyond regulatory success, Abyrx's MONTAGE has already made a significant impact in the medical field. Surgeons across various specialties, including trauma, orthopedics, sports medicine, foot and ankle procedures, and craniomaxillofacial surgeries, have widely embraced MONTAGE. The preference for MONTAGE is attributed to its extensive list of FDA-cleared applications, a track record of safety and consistent performance, and its ease of use during surgical procedures.

One of MONTAGE's standout features is its unique ability to transition from a moldable putty that adheres to bleeding bone to a hardened material with properties similar to natural bone. This transformation occurs rapidly following application. MONTAGE not only effectively controls bleeding but also eliminates the need for topical agents that can hinder bone healing, such as bone wax.

Preliminary clinical studies indicate that MONTAGE has the potential to expedite patient recovery and reduce postoperative pain, making it an innovative product with the potential to enhance sternal closure and repair in cardiothoracic surgery. The product is applied as a putty-like substance to the separated sternum, offering new possibilities for improved patient outcomes in this critical medical field.

 

Source: prnewswire.com

Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare CMO SummitHealthcare CNO Summit