Swedish medtech is revolutionising orthopaedics

Rickard Brånemark, Integrum AB, has succeeded with something not normally achievable by smaller companies: The establishment of a new medtech product in the USA. Integrum produces prostheses for which Willo makes a component: A connector that releases under high strain.

For 30 years, Rickard Brånemark has worked on setting a new standard in orthopaedics. He acknowledges that it has been a difficult journey at times.

“During the difficult times I motivate myself by thinking of all the patients who smile and thank me for giving them a new life.”

His father, Per-Ingvar Brånemark, was a pioneer in the use of titanium dental implants and would later coin the term osseointegration. Rickard, who is an orthopaedic surgeon, developed the idea further and began using the same technique to perform surgery involving prosthetic arms and legs. Thanks to his efforts, hundreds of amputees around the world now enjoy a higher quality of life.

“That is the strongest motivation of all – being able to do something that brings joy to other people. If you can then you simply have to do it.”

Better for the patients

An ordinary prosthesis is attached around the stump using a socket. Patients who use this method of attachment often experience problems such as pain, sweating, chafing and abrasions, fatigue and itching. Transfemoral amputees may feel that their prosthesis is controlling their lives, and some may not be able to use it at all.

By contrast, a prosthesis that is attached directly to the bone entails greater freedom for the patient. Life begins functioning as normal, and the patient has less pain and no longer experiences skin problems.

The only approved product

The prosthesis in question is called OPRA^TM Implant System and is used in Europe, Australia, Chile and the USA. In 2020, OPRA^TM achieved the highest possible classification as a medtech product in the USA and is the only approved product in its area of application. Today, OPRA^TM Implant System is recommended by 12 of the 20 highest ranked American hospitals.

“There are a lot of regulatory requirements to be met, but we have passed the highest barrier, which is called Pre Market Approval”, Rickard Brånemark explains.

Connector made by Willo

The connector for the transfemoral prosthesis is called Axor. It releases when subject to excess strain, in the same way that the binding on a slalom ski releases when subject to a certain level of force.

“If the connector doesn’t release, the bone could be broken. Prosthetic arms and fingers don’t need a safety connector to the same extent as a prosthetic leg, as they aren’t subject to strain from the entire body.

In total around 600 patients across the globe have prostheses that are attached using the OPRA^TM Implant System, of which 400 use the Axor connector.”

Assured quality and expertise

Integrum has been a customer of Willo for many years, and Rickard Brånemark feels that there aren’t many companies prepared to make the ongoing investments required to meet applicable quality requirements. 

“We evaluated several potential suppliers for the Axor connector, but we chose to go with Willo. They were able to assure the quality and expertise required to deliver products to the American market. This demands commitment and dedication from the supplier, and we feel that we can rely on Willo. We’re talking about components that are extremely critical to the functionality of the product. If they aren’t of requisite quality, people could end up suffering serious injuries.”

Rickard Brånemark wishes that more countries could offer patients better prostheses, but to achieve this there needs to be a broader acceptance and commercialisation of the concept.

“After 30 years of hard work, it feels like the rest of the world is finally starting to understand that this is the future, and that the future is here now.”

His next areas of focus involve dexterous hand prostheses, e-OPRA^TM , and products to reduce phantom pain. Willo will once again be contributing high-quality components to these new areas of application.