FDA Clearance to Remanufacture Da Vinci Robotic Instruments Could Present Hospitals with Substantial Savings

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Encore Medical Device Repair to Offer Remanufactured Da Vinci Instruments

EndoWrist is a significant cost driver at U.S. hospitals, and we can now provide them with the option of reducing these costs significantly without having to abandon good instrumentation and the ability to perform robotic surgeries.

Iconocare, a healthcare cost containment company, today announced it has received FDA 510(k) clearance (#K210478) to remanufacture and market used EndoWrist SI robotic attachments (8mm Monopolar Curved Scissors) originally produced by Intuitive Surgical, Inc., the company behind the Da Vinci robotic system.

Da Vinci robots are widely used in U.S. hospitals, and reusable accessories used in robotic procedures are very expensive and limited by the manufacturer to typically 10-15 uses. However, they can be used many more times when going through a controlled remanufacturing process without losing functionality. Encore Medical Device Repair has exclusive distribution rights to FDA cleared remanufactured EndoWrist SI, and access to the EndoWrist XI is expected soon.

Remanufactured EndoWrist is significantly less expensive than new EndoWrist and can save the hospital hundreds of thousands of dollars. Using remanufactured EndoWrist poses no additional patient risk, and devices function as new.

“EndoWrist is a significant cost driver at U.S. hospitals, and we can now provide them with the option of reducing these costs significantly without having to abandon good instrumentation and the ability to perform robotic surgeries. This is the only FDA clearance for a robotic instrument, and we are very excited for the financial relief we can now provide to hospitals,” says Tom Milano, President & COO of Encore Medical Device Repair.

Iconocare is a healthcare cost containment company offering provider-focused healthcare solutions combining financial responsibility and healthcare technology to improve patient care.

Encore Medical Device Repair was founded in 2022 on the vision that device and instrument reuse should play a key role in responsible healthcare. To achieve this, the founders knew they had to raise the level of quality, sophistication, transparency, and service in the industry. A focus on the highest-price, highest-utilization instrument categories allows encore to employ the most qualified technicians and deliver unparalleled service while containing costs.

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