Now that more and more physicians in Europe are offering the NUsurface® Implant to treat knee pain you might be wondering: What exactly is the NUsurface® Implant? In short, it’s an “artificial meniscus” designed to reduce knee pain, allowing patients to return to their normal activities of daily living, by replacing a medial meniscus that is damaged or deteriorating. But just how does it work? How is it made? The answers might surprise you.
Here are 10 things you didn’t know about the NUsurface® Implant:
- The NUsurface® Implant has been around more than 10 years.
The first person to receive the NUsurface Implant was a 65-year-old man in Italy who had a tear in his medial meniscus. As of his 10-year follow-up appointment, the patient and the implant were doing great. He was part of our first-in-human series of 18-patients treated in a clinical trial conducted in Europe. To date, more than 300 people have received the implant in clinical trials.
- The NUsurface® Implant is a circular disc made of Bionate® Thermoplastic Polycarbonate-urethane (PCU) – a medical grade plastic.
Bionate PCU has been used in implanted medical devices for nearly two decades. These polymers are tough, stable and extensively tested, making them ideal for long-term implanted devices. The NUsurface® Implant is in good company – Bionate is currently being used in a wide range of implanted applications, including artificial hearts, and in vascular, neurostimulation and diagnostic devices. Thanks to this remarkable material, Plastics Today recently featured NUsurface® in its list of “15 Ways Plastic was Fantastic for Medical Technology.”
- The fibres used in the NUsurface Implant are made of the world’s strongest and lightest fibre: DYNEEMA®.
DYNEEMA is 15 times stronger than steel on a weight-for-weight basis, yet it can float on water! This combination of extreme strength and low weight is used in bullet-resistant vests and highly advanced anti-ballistic vehicle armour, but also makes the perfect solution for an implant that mimics the function of the natural meniscus. DYNEEMA has been safely used in millions of patients world-wide, across a broad range of medical devices.
- The NUsurface® Implant is made in 7 different sizes, for Right and Left Knees.
The NUsurface® System includes trial implants so that your surgeon can confirm which of the seven implant sizes is the best match for your knee. Once the best size is confirmed, the disposable trial is removed and the final NUsurface implant® is inserted.
- The NUsurface® Implant moulds to your body shape.
It may be firm at room temperature, but when the implant is inserted into the knee joint through a small incision, it becomes pliable over time and conforms to the shape of the bones pushing against it (the femur on top; tibia on bottom).
- The NUsurface® Implant is designed to restore deficient biomechanics.
Through a minimally invasive procedure, the implant is semi-constrained and self-centring – allowing it to re-establish load distribution across knee joint. By distributing the load across the knee joint, this can help protect articulating cartilage from further deterioration and allows the knee to be
- The NUsurface® Implant can be easily replaced, and if necessary, permanently removed.
Since the implant is pliable and conforms to the body, there is no fixation, drilling, sutures or significant bone resection. This allows for easy removal, if necessary, to allow for future treatment options, including the option to exchange a NUsurface® implant with a new NUsurface® implant.
- The NUsurface Implant is the first “artificial meniscus” to be marketed in select European countries.
The NUsurface® implant is available on a limited commercialization in Germany, Italy, Belgium, Israel and the United Kingdom. Availability of the NUsurface® implant will be expanded in 2021.
- The NUsurface® Implant is the first implant for knee pain to receive the Breakthrough Device Designation from the U.S. Food & Drug Administration and may be available in the U.S. as early as 2021.
In September 2019, the NUsurface Implant became the first orthopaedic implant designed to treat knee pain to be granted a Breakthrough Device Designation from the U.S. Food and Drug Administration. The FDA program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions, and it is designed to ensure patients and healthcare providers have more timely access to vital devices. The NUsurface® Implant received the designation because it is designed for population of people for whom traditional treatments are insufficient to relieve their knee pain.
- The NUsurface® Implant has the potential to help hundreds of thousands of patients.
More than 720,000 patients undergo knee replacement surgery each year, and that number is expected to skyrocket to 3.5 million cases by 2030 – an increase of nearly 400 percent. The NUsurface® Implant fills a current gap in the treatment of meniscus injuries and could treat hundreds of thousands of patients who are still suffering after meniscus surgery, but who want to delay, or avoid knee replacement surgery.
If you are interested in being notified when the NUsurface® Implant becomes available in your area, click here.