Episurf Medical Updates: U.S./European Markets, Talus Study

By Julie A. Vetalice and wire services

Episurf Medical Updates: U.S./European Markets, Talus Study

Episurf Medical announced two additions to the European sales organization.

JAMO Orthopaedics has been appointed agent for the Episealer® Knee and Episealer® Talus in certain areas in the U.K. JAMO Orthopaedics focuses on the Midlands, and acts as a distributor or agent for several global orthopaedic companies. JAMO Orthopaedic will work alongside Episurf Medical's existing salesforce in the U.K.

Further, the company has added a senior sales rep in the Benelux region. Episurf Medical had representation in the region up to and including 2019, but later the region was de-prioritized awaiting the clinical data supporting a broader product launch. Now, Episurf seeks to expand further in the region.

Development of the company’s Episealer Patellofemoral System is progressing according to plan, and FDA 510(k) submission is still expected within 2021. The design for the system is now set and final device testing is presently being conducted. Episealer Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint.

Simultaneously, the company is preparing for a commercial launch in the U.S. of the Episealer Patellofemoral System during 2022.

Finally, the company announced results of a case report with 5-years’ follow-up data of the very first Episealer Talus patient.

The study reports on a 33-year old male patient who experienced persistent pain and reduced range of motion following an ankle sprain, and the patient underwent medial talar dome ankle surgery in 2016. The patient was treated with an Episealer Talus implant, and he was the first patient worldwide to receive this implant. The patient was consequently followed up at 3, 6, 12, 24, 36, 48 and 60 months using the standard subjective outcome measures.

The article reports that there was immediate pain relief, and a fast rehabilitation was achieved. Six weeks postoperatively, the patient returned to work. There have not been any limitations in activities of daily living or work-related activities until today and the patient was able to return to his athletic level and started playing soccer again. The authors conclude that the first implantation of this novel patient-specific metal implant for the treatment of focal osteochondral lesions of talus has been highly successful up to five years after implantation.

The Episealer Talus implant used in this surgical procedure was performed on a custom-made basis, implying a regulatory exemption to produce an implant before market approval.

Source: Episurf Medical

 

 

Product Labels: Knee Replacement, Ankle Replacement

Tags: Trial/Study