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Commercialization

In the last 30 years, only a few fundamentally new, synthetic degradable polymers were ever commercialized as part of an FDA-cleared medical devices, making the approval of new products based on tyrosine-derived polymers a very significant achievement.

In 1996, tyrosine-derived polycarbonates were highlighted on the cover of the Annual Report of Integra Lifesciences, a publicly traded company that had licensed these materials. Over the subsequent years, a series of commercial ventures were created. 

A tyrosine-derived polymer was used in creating a fully resorbable TYRX™ Absorbable Antibacterial Envelope for use with cardiac implantable electronic devices (CIEDs), including implantable cardioverter defibrillators (ICDs) and pacemakers. Its main purpose is to elute combination of antibiotics to prevent hospital-acquired infections for pacemaker patients.  Today, this product is cleared for marketing in more than 45 countries and has been used by over 350,000 patients. It is credited with saving the lives of hundreds of patients.  

Tyrosine derived polymers are now being used in multiple medical devices, including a fully resorbable, X-ray visible coronary stent. 

Reva Medical Inc. X-Ray Visible Biodegradable Coronary Stent

Fantom Encore is a drug-eluting bioresorbable vascular scaffold developed as an alternative to metallic stents for the treatment of coronary artery disease. After restoration of blood flow, scaffolds support the artery through the healing process and then disappear (or “resorb”) from the body over a period of time. This resorption is intended to allow the return of natural movement and function of the artery. Reva Medical’s Tyrocore is based on polymers researched and developed by the Kohn Lab at Rutgers University. 

 

Medtronic’s Tyrx Absorbable Antibacterial Envelope for Cardiac Implantable Electronic Devices

The TYRX™ Absorbable Antibacterial Envelope is designed for use with cardiac implantable electronic devices (CIEDs), including implantable cardioverter defibrillators (ICDs) and pacemakers.