Integrum AB granted premarket approval (PMA) by the United States Food and Drug Administration (FDA) for the OPRA™ Implant System.
Frame agreement worth 60 MSEK over five years signed with US Department of Defence.
The University Hospital in Vienna performs the first OPRA™ surgeries in Austria.
First deliveries to the US market in May and in October the first order from Department of Defence is received.
The University hospital in Gent performs the first OPRA™ surgery in Belgium.
A multi-center study for above-the-knee amputees will start in 2016. This multi- center study will be coordinated by the University of California San Francisco (UCSF), where Professor Rickard Brånemark has been appointed visiting professor. In addition, Integrum is part of a research program aiming to implement bone-anchored prostheses together with the
Department of Defense (DoD). Osseointegration is perceived as being uniquely suited to military patients with amputations. A research program between Integrum and the Regenerative Medicine Department, Naval Medical Research Center, at the Walter Reed National Military Medical Center, is planned for 2016. Integrum is participating in an EU grant aiming at restoring functionality for individuals with transradial amputations.
The U.S. Food and Drug Administration (FDA) announced that the OPRA™ Implant System was approved for adults who have amputations above the knee. Integrum is the first company in the world with a bone anchored prosthesis to be approved by FDA for use in the U.S.
A prospective study of 51 transfemoral amputees treated with the OPRA™ Implant System was published. The patients showed improved prosthetic use and mobility, as well as fewer problems, compared with socket prostheses. Enhanced quality of life was observed as a result of treatment with the OPRA™ Implant System. The success rate at 2 years follow up was 92 %. The first surgeries with the OPRA™ Implant System were performed in Jordan at the King Hussein Cancer Center in Amman.
In 2013, Dr Rickard Brånemark led the world’s first surgery in which neuromuscular electrodes were permanently implanted in an amputee. The new team at Centro Hospitalar do Porto in Portugal performed their first surgery with the OPRA™ Implant System.
The Axor, a connection device for the OPRA™ Implant System for lower limbs, was launched on the European market.
The Department of Orthopedic Surgery Hospital at the University Hospital of Aarhus in Denmark began to perform surgery with the OPRA™ Implant System. The Amputee Care Team at the University Hospital in Ghent in Belgium started to perform surgery with the OPRA™ Implant System.
The Hospital del Trabajador in Santiago, Chile, performed its first surgery with the OPRA™ Implant System.
The hospital Clinique Saint Roche in Montpellier, France, performed its first surgery with the OPRA™ Implant System.
The Orthopedic Surgery Department at the hospital Sant Cugat in Barcelona, Spain, performed its first surgery with the OPRA™ Implant System.
Integrum´s unique BioHelix surface was developed in collaboration with the Department of Biomaterials at the University of Gothenburg. Several experimental studies have shown more rapid healing and stronger osseointegration. The new surface will take osseointegration to the next level and will promote faster, stronger attachment to bone, thereby increasing the strength of the bone-to-implant interface.
The Plastic, Hand and Facio-Maxillary Surgery Unit at the Alfred Hospital in Melbourne, Australia, started to perform surgery with the OPRA™ Implant System.
Integrum’s OPRA™ Implant System was CE marked (OPRA™, Osseointegrated Prostheses for the Rehabilitation of Amputees). The Douglas Bader Unit at Queens Marys University Hospital in London, UK started to treat patients using the OPRA™ Implant System.
Integrum was founded by Rickard Brånemark and Per-Ingvar Brånemark in Gothenburg in Sweden.
Dr. Per-Ingvar Brånemark and Dr Björn Rydevik performed the world’s first surgery in which a patient was implanted with a transfemoral osseointegrated prosthesis in Gothenburg, Sweden.
The bone anchored hearing aid was awarded with the “Dagens Industri” innovation price.
Dental titanium implant was presented by Per-Ingvar Brånemark at an international conference in Toronto. The previous skepticism towards the osseointegration concept was finally overcome.
The first patient was treated with permanently skin penetrating implants to anchor an artificial ear.
A Swedish man, Gösta Larsson, became Per-Ingvar Brånemark’s first dental implant patient. Using a very cautious method that his research group had devised to show the greatest possible degree of respect to the living bone tissue, Brånemark inserted a set of titanium implants that Larsson would have for the rest of his life.
A Swedish professor, Per-Ingvar Brånemark, used a titanium implant chamber to study blood flow in rabbit bone and noted that the titanium implant could not be removed at the end of the experiment. He later coined the word “osseointegration” to describe the phenomenon when bone cells grow in direct contact with a titanium implant.