Innocoll

CollaRx® Gentamicin Surgical Implant: Ex-US

CollaRx® Gentamicin Surgical Implant is a peri-operative surgical implant comprised of a lyophilized collagen matrix impregnated with the broad spectrum antibiotic, gentamicin (as the sulfate salt). The product utilizes Innocoll's fully biocompatible and biodegradable CollaRx® sponge technology to deliver the gentamicin to the site of the infection or one at risk of infection.

The CollaRx Gentamicin Surgical Implant is not a substitute for systemically administered antibiotics, but an adjunct therapy clinically proven to offer a more powerful treatment or better protection over the systemic antibiotic alone.

The product is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL® for the treatment and prevention of surgical site infections. The product is routinely used in a wide variety of surgical procedures, including:

• Orthopedic surgery
• Trauma surgery
• Abdominal/Colorectal surgery
• Cardiothoracic surgery
• Vascular surgery

Mechanism of Action

CollaRx Gentamicin Surgical Implant achieves very high local concentrations of drug far in excess of the MIC (minimum inhibitory concentration) for gentamicin susceptible micro organisms (~ 4 μg/ml), yet maintains systemic levels while below the toxicity threshold (10 to 12 μg/ml); refer to Figure 1. Gentamicin's antibacterial action is concentration dependent and there is evidence to support that such high local concentrations (typically orders of magnitude above the MIC for the first 12 to 24 hours) can eradicate bacteria normally considered gentamicin resistant such as MRSE and MRSA. In addition to its antibacterial action, CollaRx Gentamicin Surgical Implant also benefits from the natural haemostasis and wound healing benefits of the fibrillar collagen sponge matrix.

Figure 1: Pharmacokinetics of CollaRx Gentamicin Surgical Implant in Osteomyelitis Patients

There are at least 62 prospective clinical trials and published case reports involving more than 7,500 patients and covering various surgical procedures that support the safety and efficacy of our CollaRx Gentamicin Surgical Implant.

Please click here to find a list of or clinical publications