Bioabsorbable polymer for medical applications has been around since the 1960s and 1970s, but the current chemistry has a number of shortcomings that can compromise surgical experience and patient outcomes.
The history of bioabsorbable polymer for medical applications dates back to the 1960s and 1970s with the introduction of polyglycolic acid (PGA) and poly-L-lactic acid (PLLA). These materials heralded a new era in the development of implantable devices that would perform a function in the body and then degrade away, leaving nothing behind.
Whilst these materials have been widely adopted and remain in common use today, they have a number of fundamental shortcomings that have been recognised in clinical practice:
- Acidic by-products of degradation that provoke a local inflammatory response that can lead to cyst formation and pain.
- An unpredictable outcome of the degradation process, where early degradation can lead to premature loss of device function and delayed degradation that can lead to an extended foreign-body response and late infection.
- Biomechanical performance issues due to lack of material strength or inability to match the modulus of host tissue.
- Processing and manufacturing limitations that constrain design freedom and lead to sub-optimal device geometries.
Brittle biodegradable materials result in early device failure
Poor degradation profiles lead to bulk erosion & fragmentation
Degradation by-products cause pain & local inflammatory response
Design constraints lead to compromised device
Over the last twenty years, biomaterial science has focused on adding materials such as calcium phosphate (CaP) and hydroxyapatite (HA) to common polymers in an effort to address these shortcomings and enhance clinical performance. However, this approach fails to address the underlying drawbacks of the polymer constituent.
Introducing 4Degra®
4Degra® was designed at the molecular level with one purpose in mind – to deliver a better bioabsorbable material for implantable medical devices. After more than 15 years’ rigorous academic research and development, 4Degra® represents the next generation of bioabsorbable polymeric biomaterials. 4Degra® successfully overcomes legacy material performance challenges and accesses the design freedom presented by precision 3D printing and other photocurative processes.
Capable of creating devices that range from soft and flexible to strong and rigid, 4Degra® resins are all formulated with 4D’s patented polycarbonate-urethane chemistry.
Softer grades of 4Degra® exhibit excellent shape memory response, making them ideally suited to minimally invasive surgical devices including stents, films, and soft tissue scaffolds.
Stronger formulations are suited to more mechanically demanding uses such as trauma fixation plates, pins, screws, and load-bearing bone regeneration scaffolds. 4D will leverage this material versatility to create best-in-class proprietary medical devices that deliver a better surgical experience and improve the quality of life for patients worldwide
