Drug-eluting biomatrix products developer Elutia has received the US Food and Drug Administration (FDA) clearance for EluPro, an antibiotic-eluting bioenvelope.

EluPro, previously referred to as CanGaroo RM, is designed to protect patients from post-operative complications arising from devices like implantable cardiac pacemakers and defibrillators.

According to Elutia, the EluPro device integrates antibiotic therapy with advanced tissue engineering to form a bioenvelope. This approach gradually transforms into a protective pocket of the patient’s tissue.

The EluPro bioenvelope is crafted from reinforced layers of natural extracellular tissue matrix, engineered to form an envelope and provide stability for implantable electronic devices.

Additionally, the device’s walls have integrated antibiotics rifampin and minocycline, offering extended delivery directly at the surgical site post-closure.  

The biomatrix products maker said that the combination of pharmaceutical and biomaterial helps to develop a healthy, vascularised pocket derived from the patient’s tissue. This approach reduces the long-term foreign body response.

Elutia CEO Randy Mills said: “Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope.

“While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device.

“We intend to rapidly extend our product offering to other indications as we fulfil our mission to humanise medicine so patients can thrive without compromise.”

The antibiotic-eluting bioenvelope has been in development since 2019 and is protected by intellectual property rights that extend beyond 2032.

The US-based Elutia plans to project EluPro as the only biological solution in the US market for protecting implantable electronic devices.

Furthermore, the device has received clearance for applications beyond cardiac implantable electronic devices (CIEDs). These includes neurostimulators and neuromodulators utilised in pain management, epilepsy, incontinence, and sleep apnoea.

Elutia intends to roll out EluPro in the US CIED market by the latter half of 2024.