Ixef PARA in the BlueBridge sternal spacer

Syensqo worked with medical device manufacturer Thoracic Innovations to develop the BlueBridge modular sternal spacer, designed for use after complex heart and chest surgery. Following some cardiothoracic procedures, surgeons may need to temporarily leave a patient's chest open until it can be safely closed. Appropriate spacing and stability must be maintained during this period. BlueBridge was developed as a standardized solution with a modular, adjustable design to support healthcare teams caring for patients in intensive care units. The device can be secured to the chest wall to maintain appropriate mediastinal space, protect the heart and provide stability until final chest closure.

Glass fiber-reinforced polyarylamide

To meet the requirements of this application, Thoracic Innovations selected Ixef PARA GS-1022 BU01, a polyarylamide reinforced with 50% glass fiber. The material provides the strength, stiffness and dimensional stability required for the device while enabling precise and efficient molding of its components.

Ixef PARA is also compatible with imaging methods frequently used in cardiothoracic patients, including chest X-ray, coronary angiography, computed tomography and magnetic resonance imaging.

Syensqo participated in the device development process, providing support in material selection as well as technical and regulatory matters related to bringing BlueBridge into clinical use.

"Syensqo was an important partner as we developed BlueBridge, helping us navigate material selection as the design evolved and providing the technical and regulatory information we needed," said Luiz Maracaja, MD, founder of Thoracic Innovations. "Ixef PARA gives us the combination of strength, precision and healthcare material performance required for this demanding application."

"Our collaboration with Thoracic Innovations demonstrates how material expertise can contribute from the earliest stages of medical device development," said Sophie Dufour, Account Manager at Syensqo. "By working closely with their team, we were able to identify Ixef PARA as the right fit for the evolving application and support them with the technical and regulatory information needed along the way."

More than 100 clinical uses

BlueBridge is commercially available in the United States. The device has been used in more than 100 patients undergoing complex cardiothoracic procedures. The collaboration involved the use of an advanced material, technical expertise and regulatory support to translate the device concept into a solution used in clinical practice.