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Integrum is a world leader in osseointegrated prosthetics for amputees. The company has developed the OPRA™ Implant, a unique bone-anchored system that is available in designs for both upper and lower limbs.
Mr. Magnus René, ORTHOWORLD Member since 2009 and former President and CEO of Arcam, has served on Integrum’s Board of Directors since 2016. The OPRA product is exciting and its impact is inspiring, and we felt that other ORTHOWORLD Members would benefit from learning more. He graciously shared his time.
How did the Integrum story come to be? What do you consider the keys to the success of Integrum in the marketplace?
Magnus René, former President and CEO of Arcam
Mr. René: Integrum´s technology of bone-anchored prostheses is based on the principle of osseointegration, which is the ability of titanium to naturally integrate with bone. Osseointegration was discovered in Gothenburg by Per-Ingvar Brånemark, M.D., Ph.D., and the first clinical application was for dental implants in 1965. Since then, many applications using osseointegration have been developed, such as craniomaxillofacial reconstructions, osseointegrated hearing aids, osseointegrated percutaneous amputation prostheses, etc. In 1998, Rickard Brånemark, M.D., Ph.D., and Dr. PI Brånemark founded Integrum with the aim to help amputees around the world to have an improved quality of life with the OPRA Implant System.
Integrum is the first company in the world developing and marketing this kind of special implant system based on long-term scientific evaluation and validation in controlled clinical studies.
What are the benefits of bone-anchored prostheses vs. traditional socket prostheses?
Mr. René: The traditional way of attaching the prosthetic limb to the body is with a socket. Socket prostheses are frequently associated with discomfort, pain, skin sores and limited range of movement, and some patients cannot use a socket and need to rely on crutches or be bound to a wheelchair.
The OPRA Implant System provides direct connection of an artificial limb to the bone, thus eliminating most of the problems caused by socket use. The patients will benefit from increased prosthetic use, better mobility, fewer problems, simplified attachment of the prosthesis and improved quality of life.
Looking ahead, bone anchored prosthetics are a prerequisite for being able to use the new exciting robotic limb systems.
Where is OPRA available today? Where is it headed next?
Mr. René: OPRA is available in 14 different countries, including the U.S., where Integrum received a Humanitarian Device Exemption approval from FDA in 2015.
Walter Reed Army Medical Center has been evaluating the OPRA Implant System for many years, and when the FDA approval came, the time was right to start a collaboration together with Dr. Rickard Brånemark. In the public sector, the first hospital to start was the UCSF Medical Center. Ms. Maria Lopez, Integrum’s CEO in Sweden, and the U.S. team are focusing on further expansion in the U.S. and the rest of the world. We will present several new centers in the next months.
What is the vision for Integrum’s future? What would you like the orthopedic device companies to know about Integrum?
Mr. René: Integrum’s OPRA Implant System is the first and only implant with an FDA approval in the U.S. Integrum is also developing the e-OPRA™ Implant System, combining implanted electrodes and advanced power prosthetics using artificial intelligence for natural control of the prosthetic limb. e-OPRA Implant System is soon to become a reality for amputees. There is an ongoing clinical trial in Europe and a clinical trial will soon start in the U.S. including collaboration with MIT, Brigham and Women’s Hospital and UCSF.
What developments/trends/changes in the bone-anchored prosthesis industry excite you the most?
Mr. René: We are glad to see increased recognition of bone-anchored prostheses around the world as a viable treatment in amputees. Bone-anchored prostheses will become the primary option for select amputees, and our product offerings providing the most natural attachment and mind-controlled solutions will aim to support the best quality of life for amputees.
What developments/trends/changes in your industry are of most concern to you?
Mr. René: Medical care systems globally are increasing the focus on cost control. Current clinical studies in the U.S. show cost benefit data, and Integrum is confident that the improved quality of life using the OPRA will be evident. While cost advantage for the whole system is difficult to quantify, we believe that the cost efficiency of the overall patient care and the Implant System in combination will help us reach more patients.
You have served the medical device industry on the supplier side with some very well-known companies, like Arcam, and more recently SLM Solutions. What advice do you have for those just starting out in the orthopedic industry?
Mr. René: The orthopedic industry is highly regulated, and that may scare people off because of how long it takes to get new products and production technologies in use. However, that also means that once you have a product in production, it will be used for a long time.
The orthopedic industry is very innovative and open to new technology, and an observation is that a lot of the technology and materials used in the orthopedic industry were brought in from other industry sectors. So, inspiration from the outside is welcome.
Personally, what is your most significant professional accomplishment?
Mr. René: For sure, it was when at Arcam we took additive manufacturing to the implant industry together with partners in Italy, among them Michele Pressacco and his team at Lima. We managed to get additive into production in a relatively short time, and it is now hard to believe that just recently additive manufacturing was perceived as a technology only for prototyping. Today, additive manufacturing is well-established for manufacturing advanced implants and it is used by all the large manufacturers. The pioneer in the industry, LimaCorporate, has now more than 10 years of experience and data from their additively manufactured implants, and they are offering a wide range of product made by additive manufacturing.
Thank you for your time and consideration.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.
Integrum is a world leader in osseointegrated prosthetics for amputees. The company has developed the OPRA™ Implant, a unique bone-anchored system that is available in designs for both upper and lower limbs.
Mr. Magnus René, ORTHOWORLD Member since 2009 and former President and CEO of Arcam, has served on Integrum’s Board of Directors since...
Integrum is a world leader in osseointegrated prosthetics for amputees. The company has developed the OPRA™ Implant, a unique bone-anchored system that is available in designs for both upper and lower limbs.
Mr. Magnus René, ORTHOWORLD Member since 2009 and former President and CEO of Arcam, has served on Integrum’s Board of Directors since 2016. The OPRA product is exciting and its impact is inspiring, and we felt that other ORTHOWORLD Members would benefit from learning more. He graciously shared his time.
How did the Integrum story come to be? What do you consider the keys to the success of Integrum in the marketplace?
Magnus René, former President and CEO of Arcam
Mr. René: Integrum´s technology of bone-anchored prostheses is based on the principle of osseointegration, which is the ability of titanium to naturally integrate with bone. Osseointegration was discovered in Gothenburg by Per-Ingvar Brånemark, M.D., Ph.D., and the first clinical application was for dental implants in 1965. Since then, many applications using osseointegration have been developed, such as craniomaxillofacial reconstructions, osseointegrated hearing aids, osseointegrated percutaneous amputation prostheses, etc. In 1998, Rickard Brånemark, M.D., Ph.D., and Dr. PI Brånemark founded Integrum with the aim to help amputees around the world to have an improved quality of life with the OPRA Implant System.
Integrum is the first company in the world developing and marketing this kind of special implant system based on long-term scientific evaluation and validation in controlled clinical studies.
What are the benefits of bone-anchored prostheses vs. traditional socket prostheses?
Mr. René: The traditional way of attaching the prosthetic limb to the body is with a socket. Socket prostheses are frequently associated with discomfort, pain, skin sores and limited range of movement, and some patients cannot use a socket and need to rely on crutches or be bound to a wheelchair.
The OPRA Implant System provides direct connection of an artificial limb to the bone, thus eliminating most of the problems caused by socket use. The patients will benefit from increased prosthetic use, better mobility, fewer problems, simplified attachment of the prosthesis and improved quality of life.
Looking ahead, bone anchored prosthetics are a prerequisite for being able to use the new exciting robotic limb systems.
Where is OPRA available today? Where is it headed next?
Mr. René: OPRA is available in 14 different countries, including the U.S., where Integrum received a Humanitarian Device Exemption approval from FDA in 2015.
Walter Reed Army Medical Center has been evaluating the OPRA Implant System for many years, and when the FDA approval came, the time was right to start a collaboration together with Dr. Rickard Brånemark. In the public sector, the first hospital to start was the UCSF Medical Center. Ms. Maria Lopez, Integrum’s CEO in Sweden, and the U.S. team are focusing on further expansion in the U.S. and the rest of the world. We will present several new centers in the next months.
What is the vision for Integrum’s future? What would you like the orthopedic device companies to know about Integrum?
Mr. René: Integrum’s OPRA Implant System is the first and only implant with an FDA approval in the U.S. Integrum is also developing the e-OPRA™ Implant System, combining implanted electrodes and advanced power prosthetics using artificial intelligence for natural control of the prosthetic limb. e-OPRA Implant System is soon to become a reality for amputees. There is an ongoing clinical trial in Europe and a clinical trial will soon start in the U.S. including collaboration with MIT, Brigham and Women’s Hospital and UCSF.
What developments/trends/changes in the bone-anchored prosthesis industry excite you the most?
Mr. René: We are glad to see increased recognition of bone-anchored prostheses around the world as a viable treatment in amputees. Bone-anchored prostheses will become the primary option for select amputees, and our product offerings providing the most natural attachment and mind-controlled solutions will aim to support the best quality of life for amputees.
What developments/trends/changes in your industry are of most concern to you?
Mr. René: Medical care systems globally are increasing the focus on cost control. Current clinical studies in the U.S. show cost benefit data, and Integrum is confident that the improved quality of life using the OPRA will be evident. While cost advantage for the whole system is difficult to quantify, we believe that the cost efficiency of the overall patient care and the Implant System in combination will help us reach more patients.
You have served the medical device industry on the supplier side with some very well-known companies, like Arcam, and more recently SLM Solutions. What advice do you have for those just starting out in the orthopedic industry?
Mr. René: The orthopedic industry is highly regulated, and that may scare people off because of how long it takes to get new products and production technologies in use. However, that also means that once you have a product in production, it will be used for a long time.
The orthopedic industry is very innovative and open to new technology, and an observation is that a lot of the technology and materials used in the orthopedic industry were brought in from other industry sectors. So, inspiration from the outside is welcome.
Personally, what is your most significant professional accomplishment?
Mr. René: For sure, it was when at Arcam we took additive manufacturing to the implant industry together with partners in Italy, among them Michele Pressacco and his team at Lima. We managed to get additive into production in a relatively short time, and it is now hard to believe that just recently additive manufacturing was perceived as a technology only for prototyping. Today, additive manufacturing is well-established for manufacturing advanced implants and it is used by all the large manufacturers. The pioneer in the industry, LimaCorporate, has now more than 10 years of experience and data from their additively manufactured implants, and they are offering a wide range of product made by additive manufacturing.
Thank you for your time and consideration.
Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
