Thank you for your interest in Episurf and the Episealer® technology. In this newsletter, you will find a summary of important events during the last months. I encourage you to read the interview with Dr. Innocenti from Milan, who performed the first Episealer® surgery in Italy a few weeks ago.
Despite the very challenging business climate given
the current pandemic, Episurf has taken some significant and critical steps during the last months:


 

• Patient recruitment in the pivotal clinical trial in the US and Europe was initiated,
• The first surgeries since the CE-clearance of our ankle implant Episealer® Talus were performed,
• The first surgery in Asia was planned,
• The results from the largest European multi-center study for the Episealer® knee implant were submitted to a scientific journal for publication, reporting on strong clinical outcomes.

 

First of all, thanks for the congratulations. I was looking for a type of medical device that would allow me to treat this kind of patient. Among the various features of Episealer, those that struck me the most were undoubtedly the possibility of adapting the implant to the patient's defect as well as your software that allowed me to analyze my patient's bone defect accurately. During the surgery, I also realized the perfect characteristics of your implant (perfect press-fit and extremely precise instrumentation designed ad hoc). Furthermore, this first patient had high functional demands, and the devices I had used up until now were unable to respond to these requests. 

Can you tell us a little bit about the patient?
As mentioned before, the patient was a "particular" patient with different requests. I had known him for some time and had tried various treatments; I had started sometime before with simple hyaluronic acid infiltrations, and then moved on to biological treatments. What I could have offered without Episealer would have been either a trochlea prosthesis or even a TKR. The patient himself suggested that I consider the Episealer hypothesis. His age (52), his pathology (4th degree osteochondral defect), and his particularly active lifestyle made him an ideal candidate for this kind of device.

What made you decide to use Episealer for this first patient?
After reading several articles and discussing with the Italian representatives of your company, the decision was simple. Episealer is a unique device that, starting from a simple MRI, you get to have a customized device for the focal defect of your patient. Thanks to your team of experts, the procedure was quick and easy. In this patient, given his anamnesis, it is more effective than biological treatments and less invasive than any other metal implant (TKR or UNI). In the past, in similar cases, I had used other "buttons" for focal defects, but with poor results (I would say: in the past, I have always used only biological regeneration devices even in elderly patients, not always obtaining the desired results. Like Episealer, I had never considered them as I am aware of several failures, as well as these devices have always aroused many doubts, especially for the accuracy of the implant and the instruments themselves). What made me think again about the benefit of this type of implant was certainly the extreme customization of the Episealer and the related instruments, both customized to the patient's needs.

How was the surgical experience?
In one word: Simple. Extremely guided and with few steps. The customized, sterile, and single-use instruments guarantee absolute perfection. The result is the perfect fit of the implant, the intervention speed (40 minutes), and the correct positioning of the surgical tools. The Epiguide (also 3D printed based on the patient's defect and identical to the final implant) guides you exactly to drill the amount of bone needed. Moreover, thanks to the dedicated sawbone, it is possible to "practice" before entering the operating field.

What are your thoughts about future use of the Episealer in your clinic?
Episealer has been and will undoubtedly be part of my clinical portfolio. The "damage report" and the preparations carried out step by step with you, from the initial design to the final production of the device, guide the surgeon towards a final decision on whether or not to choose the implant and discover our errors in evaluation. The damage marking report and the final customization of the implant are the two pillars of your device, which is extremely innovative in the field of focal knee injuries. I have also heard about the ankle – which sounds very interesting.

Press releases
In recent weeks, Episurf Medical has published several relevant news.
Please press on the links below to access the most relevant press releases:

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